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Emyria’s Specialist Psychiatrist Granted Authorised Prescriber Status in MDMA-Assisted Therapy for PTSD
Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) focused on delivering and developing new treatments for mental health and select neurological conditions, is pleased to announce the Company’s distinguished psychiatry specialist has been granted "Authorised Prescriber" status by the Therapeutic Goods Administration (TGA). The authorisation enables the prescribing of MDMA according to an ethics committee endorsed care model developed by Emyria 1 and within the strict regulatory framework established by the TGA for the treatment of Post-Traumatic Stress Disorder (PTSD). 2
HIGHLIGHTS
- Emyria's key specialist has been granted "Authorised Prescriber" approval from the TGA
- Authorisation reflects Emyria's dedication to mental health care under strict regulatory, ethical, and safety standards
- Achieving Authorised Prescriber status for MDMA-assisted therapy in PTSD care signifies a strategic step towards expanding Emyria's service offerings
Emyria’s expertise and track record in innovative clinical service development and Real-World Data capture uniquely positions us to evaluate new therapeutic options in a safe and responsible way. Achieving Authorised Prescriber status showcases Emyria's capacity for impactful and responsible growth in the field of mental health treatments."
Initial focus on Post-Traumatic Stress Disorder (PTSD):
PTSD affects approximately 1 million Australians 3. With up to one third of patients failing to benefit from conventional therapies, there is a growing need for more effective treatments. MDMA-assisted therapy (MDMA-AT) is being evaluated as a treatment for PTSD and multiple Phase 3 clinical trials have been conducted by MAPS in the USA. 4, 5
Emyria is currently studying MDMA-AT therapy for PTSD in an ethics-approved clinical trial (EMDMA-001). Experience with the trial has informed a unique delivery model for Emyria’s Authorised Prescriber program.
Authorised Prescribers must adhere to stringent TGA guidelines to ensure the highest level of patient care and safety. The authorisation is part of Emyria’s broader commitment to increasing options for mental health through robust clinical research and ethical practice.
A presentation explaining how the Authorised Prescriber milestone fits into Emyria’s broader strategy will be available on the ASX platform.
Risks associated with the use of MDMA
All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision.
Click here for the full ASX Release
This article includes content from Emyria 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.
Interim Data from Accent Pancreatic Cancer Trial Supports Continuation of Trial
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.
HIGHLIGHTS
- Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in combination with chemotherapy has been undertaken
- Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having been recorded along with four (4) unconfirmed PRs and five (5) SDs
- The median duration on trial is longer than for comparative trials of chemotherapy alone
- The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24 October 2024, 3 patients have been recruited
As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
- 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
- 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
- 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
- Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
- Median duration on trial at data cut-off is 136 days, which compares favourably with historical data for chemotherapy alone of 117 days
- Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."
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This article includes content from Amplia Therapeutics, 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.
InhaleRx Secures $38,500,000 Funding to Fully Fund Clinical Development Plans
InhaleRx Ltd (ASX: IRX) (‘InhaleRx’ ‘IRX’ or ‘the Company’), an Australian healthcare company developing unique drug-device products to address unmet medical needs in pain management and mental health sectors, is pleased to announce that it has entered into a significant funding agreement with Clendon Biotech Capital Pty Ltd (‘Clendon Biotech Capital’). This strategic partnership will provide the funding to cover all direct costs associated with the Phase 1 & 2 clinical development of the Company's key projects - IRX-211 and IRX-616a.
Highlights:
- Secured Funding: InhaleRx has secured a funding facility of up to $38.5 million from Clendon Biotech Capital to fully cover the clinical trial costs, including the associated non-clinical work and trial drug manufacturing costs for the IRX-211 and IRX-616a drug development plans through to the completion of Phase 2 clinical trials.
- Clinical Progress: This funding will enable InhaleRx to move forward with its clinical development plans for IRX211 and IRX616a, including non-clinical data. It will also enable IRX to address the requirements of the US Food & Drug Administration (‘FDA’) relevant to its recent IRX-616a Investigational New Drug (‘IND’) application.
- Focus on Transformational Therapeutics: With this strategic support, InhaleRx is well positioned to accelerate the development of breakthrough inhaled therapies for patients with unmet medical needs.
The funding agreement provides InhaleRx access to up to $38.5 million in funding, which is expected to allow the Company to reach the Phase 3 pivotal stage for both IRX-211 and IRX-616a within the next 2-3 years. The facility allows for the drawdown of funding as eligible expenditure is incurred.
Further details of the Clendon Biotech facility and options included within the proposed funding structure are included in Appendices 1 and 2.
Once approved, the Clendon Biotech Capital facility will allow the Company to immediately activate the specification adjustment and batch manufacturing work required in the manufacture of the requisite trial drugs for the proposed IRX616a (Phase 1), and IRX-211 (Phase 2) trials.
This partnership ensures that InhaleRx can move forward with the next stages of its clinical trials and non- clinical work, including addressing the further requirements outlined in FDA feedback related to its recent IND submission for IRX-616a.
While it is expected that this funding arrangement will cover all necessary clinical trial costs, InhaleRx will remain responsible for covering its operational and corporate overheads as these costs are specifically outside the scope of the funding arrangement. The Company remains confident in its ability to secure the necessary additional funding to meet these working capital costs and ensure continued operational sustainability.
About Clendon Biotech Capital
Clendon Biotech Capital is a Melbourne based venture capital investor which is keenly focused on small to mid-size bio-technology companies in its target therapeutic areas - neuroscience, gastroenterology, oncology and anti-aging.
The Board of InhaleRx views the partnership with Clendon Biotech Capital as a transformative step in securing the Company’s ability to execute its clinical development strategy, which will further position it as a leader in the inhaled therapeutics sector.
IRX’s CEO, Mr. Darryl Davies, said: "We are very excited to have Clendon Biotech Capital as a committed funding partner. This agreement enables InhaleRx to focus on advancing our key clinical programs, including addressing the requirements outlined in FDA feedback on our recent IRX616a IND application. While this partnership provides vital support for our clinical development program, we will continue to explore opportunities to fund our broader operational needs and ensure the long-term success of the Company."
The Drug Development Pathway for IRX-211
IRX-211 is a drug-device medication, specifically designed to target breakthrough cancer pain (‘BTcP’), a condition characterised by sudden, intense episodes of pain that occur despite otherwise controlled cancer related chronic pain.
IRX-211 delivers a precise dose of the medication designed to provide rapid onset relief, ensuring quick absorption and action when needed most.
BTcP can be particularly debilitating for cancer patients, and conventional treatments often fall short due to delayed onset of action or suboptimal dosing. IRX-211 aims to address this gap by providing fast, effective relief, leading to an improvement in the quality of life of individuals suffering with cancer-related pain. By offering a more targeted and efficient solution, IRX-211 expects to become a cornerstone in the pain management toolkit for cancer patients, enhancing their overall comfort and care.
With the Phase 1 clinical trial complete, the next stage for IRX-211 is to commence the planned Phase 2 Double-blind, Placebo-controlled, Multicenter, Cross-over Study with Titration Period to Evaluate the Efficacy and Safety of IRX211a for the Treatment of Breakthrough Cancer Pain (‘BTcP’) in opioid tolerant patients in order to assess safety and efficacy of IRX-211.
The trial has been strategically designed to mirror the registration trials used for the fentanyl products, which are the only FDA approved drugs for treating BTcP.
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This article includes content from InhaleRX, 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.
Positive results from Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) Study
TrivarX Limited (‘the Company’) (ASX: TRI) is pleased to announce positive top-line results from the Company’s recently completed Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study utilising its proprietary AI-backed algorithm, MEB-001. MEB-001 uses EEG and ECG signals recorded during sleep to identify current Major Depressive Episode (cMDE).
Highlights:
- Analysis of 400 patients in Phase 2 SAMDE study for current Major Depressive Episode (cMDE) study utilising MEB-001
- MEB-001 is TrivarX’s proprietary AI-driven algorithm which can assist with the effective screening of a cMDE
- MEB-001 performance results from Phase 2 SAMDE study reported high performance, marking a significant achievement in the Company:
- Sensitivity: 87% (95% CI 73-95%)
- Specificity: 72% (95% CI 66-77%)
- Positive Predictive Value: 35% (95% CI 27-45%)
- Negative Predictive Value: 97% (95% CI 93-99%)
- Results provide strong validation of MEB-001’s ability to assist in the screening and diagnosis of a cMDE – a condition which is commonly misdiagnosed
- There is currently no screening undertaken for cMDE in sleep centres in the US or globally, representing a major commercial opportunity for TrivarX
- Results advance TRI’s aim to become the first depression screening tool used in clinical practice in sleep centres
There is a well-established connection between mental health conditions, such as depression, and sleep disturbances. People with insomnia may have a tenfold higher risk of developing cMDE and among people with depression, 75% of sufferers have trouble falling or staying asleepi. Furthermore, misdiagnosis of major depressive disorder is estimated at upwards of 65% in the USii. Despite this, depression screening is not routinely included in sleep studies, even though up to 21% of people undergoing a sleep study have depressioniii.
Positive results from SAMDE study highlight MEB-001’s significant potential:
The objective of the study (ClinicalTrials.gov ID NCT05708222) was to use MEB-001 to detect the likelihood of a cMDE using Clinician Reporting Outcomes (CRO) assessment in individuals referred to a sleep clinic. A total of 400 patients were recruited across 15 sleep centres in the US. Out of these, 73 patients were excluded due to incomplete data or a split night/titration sleep study. MEB-001 also automatically identified 32 patients with significant anomalies in their sleep data. Notably, the MEB-001 algorithm was locked prior to the analysis ensuring no data from Phase 2 was used in its training.
Analysis of the results showed that MEB-001 reported promising performance across key parameters including sensitivity of 87% (95% CI 73-96%), specificity of 72% (95% CI 66-77%), positive predictive value (PPV) of 35% (95% CI 27-45%) and negative predictive value (NPV) of 97% (95% CI 93-99%) (refer table below).
These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.
Management commentary:
Non-executive Chairman, David Trimboli said: “We are very excited to share the results from our Phase2 study, which highlight the effectiveness of MEB-001 in screening for cMDE. This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which was increased from 71% in Phase 1, to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE. Our very high NPV validates MEB-001’s potential as a screening test, with the likelihood of having depression when testing negative to be less than 3%.
“There is currently no screening undertaken for cMDE in sleep centres in the US or globally. Our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres and marks a significant achievement in the Company’s history.”
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This article includes content from TrivarX, 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.
Positive Phase 2a Fibromyalgia Results Deliver Pain Reduction in 100% of Patients, Strengthening IP Position and Clinical Trial Strategy
Tryptamine Therapeutics Limited (‘Tryp’ or the ‘Company’) (ASX: TYP), a clinical-stage biotechnology company is pleased to advise it has received highly encouraging, positive results from its recently completed Phase 2a clinical trial conducted in collaboration with the University of Michigan (‘UOM’) (refer ASX announcement: 10 July 2024). The results are both significant and clinically meaningful, and were presented by UOM researchers at the International Association for the Study of Pain (‘IASP’) 2024 World Congress in the Netherlands on 9 August 2024.
- Phase 2a fibromyalgia trial undertaken with University of Michigan (“UOM’) with results presented at the IASP 2024 World Congress on Pain 9 August 2024 in the Netherlands
- All patients dosed with TRP-8802 (TYP’s oral psilocybin formulation), and administered psychotherapy reported an improvement in fibromyalgia pain severity, sleep, pain interference and at least 3 other endpoints measured one month after dosing
- Fibromyalgia is a condition associated with widespread pain – 1m people in Australiai and ~10m people in the USii suffer from it and there are currently limited treatment options
- Results highlighted that there was a clinically meaningful reduction in pain, pain interference and fatigue
- Patients also reported a number of other improvements including clinically meaningful improvements in quality-of-life measures such as sleep, physical activity, and the ability to participate in daily social activities
- Clinically meaningful reduction in anxiety and improved cognitive abilities were also reported in 4 out of 5 patients dosed
- In addition, one patient reported during follow-up that their sense of smell had returned following a COVID- 19 diagnosis in 2021
- Results highlight the significant potential for psychedelic-assisted therapy as a compelling treatment pathway for fibromyalgia when compared to the inadequacies of incumbent treatments
- Results considerably strengthen Tryp’s IP position and lay a strong foundation for a future trial using TRP- 8803 (IV-infused psilocin) – Phase 2 trial planning now underway and expected to commence H1 2025
- Additional clinical trials progressing well at MGH for patients with IBS, and the beginning of Cohort 3 in the TRP-8803 Healthy Volunteer Study expected to begin soon – updates to be provided in due course
The trial was designed to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia, a condition associated with widespread pain and comorbidities that significantly impact daily living and patient well-being. The trial was undertaken by the UOM, a top-ranked public university in the US in collaboration with Tryp.
Results highlighted that 100% of patients experienced reductions in fibromyalgia pain, sleep disturbance and pain interference (refer figures one and two below).
Whilst appreciating the limitations of the small number of patients and the open label nature of the ‘signal’ style study, the results are highly encouraging and considerably strengthen TYP’s intellectual property position. Further, the results validate Tryp’s clinical trial approach targeting nociplastic pain with an initial focus on fibromyalgia and will inform an additional clinical study utilising TRP-8803 (IV-infused psilocin), which is expected to commence H1 2025.
Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)
Trial background:
The study was an open-label clinical trial with psychotherapy, seeking to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with fibromyalgia. A total of five patients were recruited and were administered two doses of TRP-8802 in 15mg initial dose and 25mg second dose formats, two weeks apart. Patients were administered psychotherapy in concert with TRP-8802 and results were compared to baseline values one month following the completion of the second dose.
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This article includes content from Tryptamine Therapeutics 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.
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