- AustraliaNorth AmericaWorld
Investing News NetworkYour trusted source for investing success
- Lithium Outlook
- Oil and Gas Outlook
- Gold Outlook Report
- Uranium Outlook
- Rare Earths Outlook
- All Outlook Reports
- Top Generative AI Stocks
- Top EV Stocks
- Biggest AI Companies
- Biggest Blockchain Stocks
- Biggest Cryptocurrency-mining Stocks
- Biggest Cybersecurity Companies
- Biggest Robotics Companies
- Biggest Social Media Companies
- Biggest Technology ETFs
- Artificial Intellgience ETFs
- Robotics ETFs
- Canadian Cryptocurrency ETFs
- Artificial Intelligence Outlook
- EV Outlook
- Cleantech Outlook
- Crypto Outlook
- Tech Outlook
- All Market Outlook Reports
- Cannabis Weekly Round-Up
- Top Alzheimer's Treatment Stocks
- Top Biotech Stocks
- Top Plant-based Food Stocks
- Biggest Cannabis Stocks
- Biggest Pharma Stocks
- Longevity Stocks to Watch
- Psychedelics Stocks to Watch
- Top Cobalt Stocks
- Small Biotech ETFs to Watch
- Top Life Science ETFs
- Biggest Pharmaceutical ETFs
- Life Science Outlook
- Biotech Outlook
- Cannabis Outlook
- Pharma Outlook
- Psychedelics Outlook
- All Market Outlook Reports
Execution of Variation to Facility Agreement with PURE Asset Management, Company to Seek a Sale Transaction
Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (Hydralyte North America or the Company) advises that today it has signed a variation to its facility agreement with boutique asset manager and existing substantial shareholder PURE Asset Management Pty Ltd as trustee for The Income and Growth Fund (PURE or PURE Asset Management) as previously announced to the market on 17 October 2022 (Original PURE Facility).
KEY HIGHLIGHTS
- Variation provides A$1.7m in new funding, subject to the requirement of a waiver of ASX Listing Rule 10.1 in order to amend the Original PURE Facility
- Variation includes the potential for two additional tranches valued at A$1.5m each, which can be accessed at the discretion of PURE Asset Management
- New funding will be used in order to seek to implement a sale of the Company or the Company’s business (‘Sale Transaction’) for the benefit of stakeholders
- Hydralyte to operate in the ordinary course of business as it progresses a Sale Transaction
The Company intends to use the funding available under the Amended PURE Facility to progress a Sale Transaction.
While the Company advances opportunities associated with a Sale Transaction, it will continue to operate in the ordinary course of business. Hydralyte has sufficient inventory on hand to satisfy retail demand and remains actively engaged with existing and potential new stockists. The Board and management are continuing to review additional cost reductions measures, which will allow the Company to prolong its existing cash balance, which at 26 March 2024 is US$1.2m.
A detailed summary of the terms of the Amended PURE Facility and the ‘Second Warrant Deed’ entered into between the Company and PURE is provided below.
Company to seek a Sale Transaction
The Company is not expected to be cashflow positive in the near-term and requires significant additional capital to execute on its market opportunity in North America and Canada.
Market conditions are presently very challenging for emerging companies that are yet to become cash flow positive. The Company’s leveraged balance sheet adds further complexity and difficulty in raising capital.
The Board engaged New York-based Two Roads Capital in 2H2023 in order to seek to procure a strategic equity investor, change of control transaction or asset divestment for the benefit of shareholders (refer Appendix 4E of 29 February 2024). The Company is currently in progressed discussions with certain potential acquirers, however no binding or non-binding offer has been received in writing and there is no guarantee that any Sale Transaction will eventuate. The Company will update the market as and when required in accordance with the Listing Rules.
The Company has assessed and sought to execute on a range of different funding options in order to capitalise the business. It has been unable to garner sufficient support from shareholders for an equity capital raising and has been unable to procure new equity investors.
The Board is of the view that the Company is unable to access the level of capital required to get the business to breakeven or better in a short period of time, resulting in the Board’s decision to seek a Sale Transaction to maximise shareholder returns.
PURE Asset Management, which holds 11.4% of the Company’s issued shares, has agreed to vary the Original PURE Facility in order to advance the Company an additional A$1.7m (for a total of A$8.2m of senior secured debt which would be owed to PURE), in order to fund the business while it seeks a Sale Transaction for the benefit of all stakeholders. The Amended PURE Facility requires a waiver of ASX Listing Rule 10.1 in order to take effect. If the Amended PURE Facility does not take effect then the Original PURE Facility will not be amended and the additional funding will not be available.
The Amended PURE Facility also includes two new additional tranches, valued at A$1.5m each, which can be accessed at the discretion of PURE Asset Management. The Amended PURE Facility also provides for a ‘Second Loan’ of $5.5m, which can be accessed at the discretion of PURE Asset Management until 31 December 2024. The Second Loan was provided for in the Original PURE Facility and the terms of the Second Loan were amended as announced on 3 August 2023.
Assuming drawdown of the $1.7m, this amount, plus net cash at bank is expected to be exhausted in July 2024.
In the event that the Company is unable to procure a Sale Transaction by July 2024, additional debt or equity capital would be required in order for the Company to continue operations as a going concern. While the Amended PURE Facility contemplates two additional tranches of a total of A$3.0m of debt available (in addition to the ‘Second Loan’ of $5.5m), the availability of those additional tranches (and the Second Loan) is at PURE’s discretion. If additional capital was required, there is no guarantee that the Company would be able to raise it.
The Company has chosen to obtain the debt from PURE (a ‘Listing Rule 10.1 party’ by virtue of its 11.4% shareholding in the Company) via the Amended PURE Facility because it is unable to raise any meaningful level of equity capital from existing shareholders or new investors in the time period required. After assessing a range of options, the Board considers that the debt being provided by PURE is the only funding available within the current time requirements.
Given the above comments including the lack of success with alternative funding, the Board considers that the terms of the Amended PURE Facility are fair and reasonable for shareholders.
Click here for the full ASX Release
This article includes content from The Hydration Pharmaceuticals Company Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Hydralyte International Investor Kit
- Corporate info
- Insights
- Growth strategies
- Upcoming projects
GET YOUR FREE INVESTOR KIT
Hydralyte International
Overview
Hydralyte International (ASX:HPC) is an ASX-listed rapid hydration solutions business focused on the lucrative North American market. With an established supply chain in Canada and the United States, the company consolidated its market position in FY23 with a 10 percent increase in net sales to $10 million. The impressive increase in group sales was achieved with a disciplined cost focus which flowed through to a significant US$5.7 million in cash savings. And there was ongoing momentum in the first quarter of FY24, with consistent growth in net sales to US$2.17 million on strong gross margins of 56 percent.
Hydralyte’s multi-channel distribution strategy includes a targeted growth through ecommerce. Its rapid rehydration product has been the number one SKU in the hydration category on Amazon Prime Day in Canada, where it's the number two hydration brand overall with a 21 percent market share. Starting on Prime Day, Hydralyte delivered ~US$140,000 in gross sales over 48 hours.
It's also worth noting that all this revenue growth – alongside a partnership with Shay Mitchell – occurred with an ongoing reduction in marketing expenditure. In 2024, marketing costs as a percentage of net revenue decreased to 37 percent from 48 percent in Q1 2023. This is due in part to the company's solid leadership team, featuring professionals with decades of expertise in health and wellness, as well as heavy brand investments which have been made throughout 2022.
In Australia, New Zealand and parts of Southeast Asia, Prestige Consumer Healthcare (NYSE:PBH) holds the exclusive sales and distribution rights to Hydralyte products. PBH is an American over-the-counter healthcare marketing and distribution company, dating back more than 100 years.
Hydralyte International's robust supply chain, sales trajectory, manufacturing approach and product strategy are far from the only reasons it shows such promise as an investment. Current market trends also significantly favor the company's core value proposition. Valued at US$1.68 billion in 2023, the global electrolyte hydration drinks market is expected to reach US$2.78 billion by 2033 as consumers turn away from high-sugar, low-electrolyte drinks and towards more clinical hydration products.
Roughly 75 percent of Americans are dehydrated at any given time. The reasons are many and varied, ranging from travel and exercise to alcohol and illness. Its symptoms are something many of us have simply learned to live with – irritability, brain fog, dizziness, increased thirst, dry mouth and fatigue, to name just a few.
Hydralyte fits the bill perfectly for these consumers. Founded with the goal of making a difference through better hydration, Hydralyte is able to treat dehydration more effectively than the majority of sports drinks on the market. Thanks to its proprietary formula – which uses a precise ratio of water, electrolytes and glucose based on the World Health Organization's recommended formula for rapid rehydration.
Hydralyte is available in three forms: ready-to-drink, tablet and dissolvable powder stick. All three are widely accepted in the medical community. Hydralyte is also frequently used by professional athletes as an alternative to sports drinks.
In short, thanks to its market position, strong leadership and science-based formula, Hydralyte represents the perfect opportunity for investors to enter the lifestyle sports market.
Company Highlights
- Hydralyte International is a rapid hydration drink business with a focus on North America and established supply chains in both the United States and Canada.
- The company’s latest financials show a consistent upward trajectory with respect to its key growth targets:
- 10 percent increase in FY2023 net sales to US$10 million
- 2ppt increase in gross margin to 54 percent resulting in a 15 percent increase in gross profit from US$4.7 million to $5.4 million
- Net sales of US$2.17 million in Q1 2024, up 2 percent on in Q4 2023 with an uplift in gross margins to 56% (adjusted for one-off items)
- Strong momentum in FY24 with underlying sales growth for Q1 2024 of US$2.62 million, an increase of 23 percent from the previous quarter.
- Appointment of leading health and wellness products broker LeBeau Excel as new national sales broker for Canada, giving Hydralyte the ability to significantly expand its footprint in the Canadian market.
- Ongoing product development with a focus on high-margin growth channels, including Hydralyte Rapid Rehydration, a unique formula to take advantage of the lucrative ready-to-drink category for hydration products
- In addition to a solid manufacturing base and supply chain, Hydralyte is supported by leaders with decades of experience in health and wellness.
- Hydralyte products are widely accepted in both the medical and athletic communities. As a result, the company is well-positioned to leverage the fast-growing electrolyte hydration drinks market.
Core Product Offering
Hydralyte Rapid Rehydration
Hydralyte is based on the World Health Organization's recommended formula for rapid rehydration. Made from all-natural ingredients, it contains the precise ratio of glucose and electrolytes necessary to rehydrate. Its innovative formula contains up to 75 percent less sugar and four times more electrolytes than the majority of sports drinks.
Highlights:
- Multiple SKUs: Available as a tablet, powder and premade drink, Hydralyte comes in a range of different flavors and formulations, including:
- Liver Support: 7 key electrolytes, six antioxidants, ginger, turmeric, milk thistle and prickly pear.
- Apple Cider Vinegar: 4 key electrolytes, apple cider vinegar, vitamins B12, B6 and C.
- Collagen: 5 key electrolytes, Verisol collagen, vitamin C and zinc.
- Immunity with Elderberry: 7 key electrolytes, vitamin C, magnesium and zinc.
- SPORT: Launched in 2022, these tablets are designed with the needs of athletes in mind.
- Under development: Hydralyte Rapid Rehydration, a unique formula with inherent advantages in comparison to competitor products in the lucrative ready-to-drink product category
- Promising Partnerships: In December 2022, Hydralyte launched a brand partnership with Shay Mitchell, a Canadian actress and entrepreneur with over 36 million Instagram followers. The two parties launched a co-branded product through HPC eCommerce channels and Amazon USA to leverage Ms Mitchell’s high profile in the North American wellness market.
- Strategic Agreements: Recently appointed LeBeau Excel as its new sales broker to significantly expand Hydralyte’s footprint in the Canadian market. Along with a strong sales team and in-store support, the Lebeau Excel appointment is expected to generate additional margin growth through more streamlined distribution.
Management Team
Oliver Baker – CEO
Oliver Baker is the former general manager of Swisse Wellness USA, a vitamin, supplement and skincare brand that in 2015 sold for US$1.7 billion. During his tenure at Swisse, Baker employed a dedicated eCommerce strategy that enabled a successful US launch. He also led the integration team in Guangzhou, migrating ~US$73 million in sales and building a local team in the Chinese market.
Prior to his position at Swisse, Baker worked in multiple global and national sales and marketing roles with a focus on sports sponsorships.
Adem Karafili – Independent, Non-executive Chairman
A registered CPA and business professional with more than 15 years of experience, Adem Karafili has operated in leadership positions across a range of different sectors and industries. Most recently, he spent several years at Swisse Wellness, beginning as chief financial officer before becoming chief operating officer and managing director. While there, he helped to establish Swisse as a leading global health and wellness brand. Karafili holds a Bachelor of Business Administration in accounting and is chairman of multiple health and wellness corporations.
Chris Kavanaugh – CFO
Chris Kavanaugh has over 20 years of experience running finance and operations for growing startups from inception to US$30M+ in revenue. He has worked with Hydralyte for over five years, starting as a controller before being promoted to chief financial officer in 2021. Prior to his position at Hydralyte, he served as a director of finance for companies including Fullbridge, Education Incorporated and OneVision Resources. Kavanaugh has a bachelor's degree in accounting and management with a double major in information systems from Indiana University of Pennsylvania.
Nick Berry – Non-executive Director
Nick Berry brings over 19 years of experience in the Australian finance industry, specialising in equity and debt capital markets, mergers and acquisitions and strategic planning. With a proven track record in raising capital and structuring and negotiating complex financial transactions, Nick has demonstrated extensive expertise and leadership in the field. He previously served as an Executive Director at Nomura Australia and is currently a Director of PURE Asset Management Pty Ltd.
Margaret Hardin – Independent, Non-executive Director
Margaret Hardin has served as CEO and CFO for numerous major product companies in the United States including Baby Super Brands, ERGObaby Carrier Incorporated and Munchkin. With over two decades of experience, Hardin has a well-established reputation for driving growth through innovation, strategic acquisitions and geographic expansion. She holds a BBA from New Mexico State and an MBA from the Booth Graduate School of Business at the University of Chicago.
Brandon Fishman – US Advisor
Brandon Fishman is the Founder and CEO of VitaCup, a vitamin-infused functional coffee and tea brand that surpassed US$20 million in sales in five years. Fishman has worked with multiple Fortune 500 brands in a range of different capacities, in the process building up considerable entrepreneurial wisdom. Other companies founded by Fishman include NewCondosOnline and Internet Marketing Incorporated. Fishman holds a Bachelor of Business Administration and Finance from Emory University and a Master's in Real Estate & Business from the University of San Diego.
StickIt Technologies Inc. Announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults for 2025
StickIt Technologies Inc.(the" Company "or "StickIt") (CSE: STKT), an Israeli Canadian technology company, announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults and start the research in 2025 once fund raising will be completed.
Stickit Technologies has developed a straw plus cartridge for delivering vitamins and/or medications for children and/or adults who have difficulty swallowing pills or for children who regularly miss medications and/or vitamins. The company, which filed a patent for a straw plus cartridge for transporting cannabinoids and/or medications, decided to develop a model of a medical straw for transporting vitamins and medications for children and adults.
The company intends to raise 1.5 million Canadian dollars for the new medical straw project during Q1 and Q2 2025. StickIt Technologies will establish a new subsidiary named "Stickit Pharma Ltd". and will be owned by the public company and the new investors who will join.
The company intends to seek partnerships with generic pharmaceutical companies globally that are interested in being part of the research and submission for FDA approval.
"This is a significant breakthrough for our company and the investors." says Eli Ben Haroosh, CEO of StickIt Technologies Inc. "We are looking for every opportunity to develop our technology and lead the global market. I believe that if we will raise the necessary fund and also succeed in raising partnerships with generic pharmaceutical companies, making Stickit a pharma leader very soon." concluded Ben Haroosh.
About StickIt Technologies Inc
StickIt is a technology company that invented and manufactures innovative products ("devices") that can contain varying quantities of Catabolites or Vitamins for recreational and medical users. Its operating model is to establish joint ventures/licensees ("partners") in countries around the world that will establish a production facility in which they will add the cannabinoid content to the "sticks" and "straws" produced and supplied by StickIt. The Company's precise dosing options cater to a wide range of effects, including painkilling, energizing, focus, sleep improvement, etc., and can be tailored to meet local preferences and regulations. StickIt Technologies serves customers worldwide.
For more information, please contact:
StickIt Technologies Inc.
Eli Ben Haroosh, CEO
E: info@stickit-labs.com
Sophie Galper , CFO
E: sophie@stickit-labs.com
Website: www.stickit-labs.com
Facebook: @Stickit
Twitter "X": @STICKIT74776509
LinkedIn: @Stickit-labs
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by StickIt Technologies Inc. Readers are cautioned not to place undue reliance on forward-looking statements.
Invion Doses First Patient in Phase I/II Non-Melanoma Skin Cancer Trial
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce the dosing of the first patient in its Phase I/II non- melanoma skin cancer (NMSC) trial conducted at Veracity Clinical Research (Veracity) in Brisbane.
Highlights:
- First patient has been dosed in Invion’s open label Phase I/II non-melanoma skin cancer (NMSC) trial using topical INV043.
- The study is being conducted at Veracity Clinical Research’s facilities, based in Queensland Australia.
- Skin cancer is one of the world’s most common cancers and NMSC constitutes >98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322.
- Preclinical studies indicate INV043 may have distinct advantages over current NMSC treatments, such as efficacy without scarring and with minimal pain.
- The NMSC trial follows the release of promising Phase II prostate cancer trial results using INV043, and Invion plans to leverage the NMSC data into a planned Phase II anogenital cancer trial
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.
Currently, the mainstream treatment for SCC and BCC is surgery, which can lead to permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
Click here for the full ASX Release
This article includes content from Invion Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Resonance Contracted by Major Global Pharma Company for Clinical Drug Trial Worth $13.775 Million over 24 Months
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global operations (Customer) to be the local Australian sponsor, and to provide clinical research organisation (CRO) services, trial site services, and imaging analysis services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $13.775 million in revenue to the Resonance group over the next ~24 months, with the first payment of AUD $2.066 million due within 30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO Services), will serve as CRO and Local (Australian) Sponsor for the Customer and will engage and make payment to the institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of regulatory approvals to commence the Clinical Trial including human research ethics committee approval (Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along with clinical trial site services through its recently acquired TrialsWest business. It is notable that trial sites are among the largest vendors for clinical trials of this nature, so a benefit of the TrialsWest acquisition is that a significant portion of the revenues payable to trial sites will now stay within the Resonance group.
The Company expects patient recruitment for the Clinical Trial could commence in early 2025, subject to receipt of Regulatory Approvals, with both TrialsWest sites expected to play a key role in the recruitment of subjects and the conduct of the Clinical Trial.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning and highly technical global pharma and clinical trials markets.
The material commercial terms of the Agreement are set out at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct result of the incredible work the team have done in executing the existing clinical trial with the customer and more broadly the Company’s focus on winning more work in the global clinical trials ecosystem. This illustrates our ability to win repeat work from customers, and our capacity to scale the size of contract wins.”
This announcement has been authorised for release in accordance with the delegated authority of the Board of Directors of Resonance Health Ltd.
Click here for the full ASX Release
This article includes content from Resonance Health Ltd, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
ISLA-101 Phase 2a/b PROTECT Clinical Trial Progress Update
Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to announce progress on its ISLA-101 Phase 2a/b clinical trial in dengue fever.
- All key data samples have been collected following dosing of all subjects in the Phase 2a (prophylactic) trial as part of Island’s ISLA-101 Phase 2a/b PROTECT clinical trial in dengue fever
- Data currently being consolidated for review by the Safety Review Committee (SRC) in the coming weeks
- On track to release SRC recommendation on advancing the trial to Phase 2b by end of this calendar year
Following the announcement (ASX: 3 October 2024) that all subjects in the Phase 2a cohort of the trial had been dosed, Island confirms it has now collected the required samples to analyse how the viremia (viral load) levels in the blood of trial subjects have changed through the study. Other samples are being analysed for pharmacokinetic data as well as other blood analyses.
This data is currently being consolidated for review by the Safety Review Committee (SRC), who will meet in the coming weeks. The SRC will evaluate the safety of ISLA-101 in dengue infected individuals and consider if there is evidence of anti-dengue activity. They will then make a recommendation regarding advancing the trial to the Phase 2b cohort before the end of the calendar year.
Island’s CEO and Managing Director, Dr David Foster commented, “We are very pleased to be able to report that 46 days into the trial, we’ve collected the key data required for evaluation by the Safety Review Committee. From here, while we will continue to check in with patients up to 90 days post dosing, we look forward to providing all the data to the SRC for evaluation in the coming weeks. Importantly, this means we remain on track to report data before the end of the year from our Phase 2a component, and next steps for the Phase 2b cohort before the end of the year.”
Phase 2b will include 10 subjects randomised 8:2 (active: placebo) and will examine if ISLA-101 has activity as a treatment against dengue infection. This is the first time a potential countermeasure to combat the dengue virus, which afflicts more than 400 million individuals a year and for which there is no therapeutic option, is being investigated as both a preventative and therapeutic measure.
To subscribe to Island’s monthly newsletter, IslandWatch, and other forms of email communications, please visit this page of our website.
Click here for the full ASX Release
This article includes content from Island Pharmaceuticals, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Latest News
Hydralyte International Investor Kit
- Corporate info
- Insights
- Growth strategies
- Upcoming projects
GET YOUR FREE INVESTOR KIT
Latest Press Releases
Related News
TOP STOCKS
Investing News Network websites or approved third-party tools use cookies. Please refer to the cookie policy for collected data, privacy and GDPR compliance. By continuing to browse the site, you agree to our use of cookies.