Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”), a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today is pleased to report further clinical efficacy and the safety results for all 14 female paediatric patients who have now completed 20 weeks of daily oral treatment with NTI164 under the Company’s one year extension period of the Phase I/II clinical trial investigating the use of NTI164 in Rett Syndrome.
Key Points:
Dr Thomas Duthy, Executive Director of Neurotech International said “We are pleased to see these patients continue to do very well on extended treatment with NTI164, with zero safety events recorded relating to diarrhoea and nausea/vomiting from week 12 to week 20 with zero weight loss recorded. Our safety and efficacy to 20 weeks is trending favourably when compared to the current FDA approved treatment, DAYBUE™ (trofinetide). Rett Syndrome represents an attractive market opportunity for NTI164, with a potential annual market opportunity of approximately US$2.0 billion. We are currently working with our clinical advisors and Professor Ellaway (our newly appointed Chief Medical Officer) on the design of a registration directed Phase III clinical trial.”
A caregiver of a patient in the NTIRTT1 trial commented after 20 weeks of treatment with NTI164“Increased use of eye gaze technology and increased ability to use the eye gaze accurately when making choices.”
Clinical Improvement Continues on NTI164
Clinical improvement was assessed by the clinician using the gold standard, Clinical Global Impression - Improvement (CGI-I), which measures how much the patient's illness has improved or worsened relative to a baseline state at the beginning of NTI164 treatment and ranges from 1 – “Very Much Improved” to 7 - “Very Much Worse”. A decrease in CGI-I score indicates improvement. Based on the CGI-I primary endpoint at 12 weeks Neurotech has four core domains of interest – communication skills, mental alertness, socialisation/eye contact and anxiety – which will likely form the basis of the CGI-I measures required for a registration-directed Phase III clinical trial of NTI164 versus placebo.
There was a statistically significant difference (improvement) in CGI-I in these four core domains at 20 weeks versus baseline; with a mean difference of -1.3 (p=<0.001), versus mean difference of -0.9 (p=0.001) at 12 weeks. Overall, the 20 week data showed an improvement of 33% versus baseline (compared to 23% improvement at 12 weeks). Between 12 to 20 weeks, there was an additional CGI-I improvement of -0.4, representing a significant, additional improvement of 13% (p=0.007), which continues the downward trajectory of clinical improvement overall.
At 20 weeks, 100% of patients showed improvement (versus 93% of patients at 12 weeks) with; 57% very much or much improved (versus 36% at week 12) as shown below.
The individual measures of CGI-I in the four core composite measures at 20 weeks all showed continued improvement from 12 weeks: Communication Skills (mean difference -0.2), Mental Alertness (mean difference -0.6), Socialisation/ Eye Contact (mean difference -0.3) and Anxiety (mean difference -0.3).
Rett Syndrome symptoms via RSBQ were stable
The Rett Syndrome Behavioural Questionnaire (RSBQ) consists of 8 domains/subscales that reflect the core features of the disease: General Mood; Breathing Problems; Hand Behaviours; Repetitive Face Movements; Body Rocking and Expressionless Face; Nighttime Behaviours; Fear/Anxiety; and Walking/Standing.
At 20 weeks, patients receiving NTI164 showed a clinically meaningful 24% improvement in total RSBQ score versus baseline (p<0.001). There was no further improvement in RSBQ scores between week 12 and week 20 with RSBQ measures relatively stable (mean difference 2.9, p=0.08). At commencement the average RSBQ total score for the patients was 44.6 compared to 31.2 at 12 weeks and 34.1 at 20 weeks.
Click here for the full ASX Release
This article includes content from Neurotech International 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.
Completed enrollment in the study lead-in for the VERITAC-3 Phase 3 trial in the first-line setting; continued enrollment globally in multiple clinical trials of vepdegestrant in ER+HER2- metastatic breast cancer, including the VERITAC-2 Phase 3 trial in the second-line setting–
– Completion of enrollment in VERITAC-2 expected in 4Q24 and topline data readout now expected 4Q24/1Q25 –
– Received $150 million upon close of ARV-766 license agreement and sale of preclinical AR-V7 program to Novartis; potential for up to an additional $1.01 billion based on achievement of development, regulatory and commercial milestones and future royalties –
– Strengthened executive team with the appointment of Andrew Saik as Chief Financial Officer and the promotions of Ian Taylor to President of R&D, Angela Cacace to Chief Scientific Officer, and Randy Teel to Chief Business Officer –
NEW HAVEN, Conn., July 30, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.
"During the second quarter, we continued making meaningful progress across our entire portfolio, with upcoming milestones that will further support our mission to improve patient lives with pioneering therapies from our revolutionary PROTAC ® protein degradation platform," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "The readout of VERITAC-2, our first Phase 3 clinical trial, will be a landmark event for Arvinas. We are on-track to complete enrollment in the fourth quarter of the year, with topline data anticipated in either the fourth quarter of 2024 or first quarter of 2025. If positive, we believe these results will support our first new drug application filing and our transition to a commercial-stage company, assuming regulatory approval."
"We are well on our way to becoming a multi-product, commercial-stage organization with strong leadership and a robust pipeline across several indications," continued Dr. Houston. "Our first PROTAC degrader with the potential to treat neurodegenerative diseases, ARV-102, was recently cleared to initiate the multiple ascending dose portion of our Phase 1 clinical trial. In addition, we initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with our PROTAC BCL6 degrader ARV-393. I'm excited by the progress we have made and the ongoing confidence we have in our PROTAC platform, which was further validated by our recent strategic transaction with Novartis. We believe Novartis will accelerate and broaden the development of ARV-766 as a potential best-in-class treatment for patients with prostate cancer."
Recent Developments and 2Q Business Highlights
Vepdegestrant
Strategic Transaction with Novartis
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader
ARV-393: Oral PROTAC BCL6 degrader
Corporate
Anticipated Upcoming Milestones and Expectations
Vepdegestrant (ARV-471)
As part of Arvinas' global collaboration with Pfizer, the companies plan to:
Pipeline
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027.
Second Quarter Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position : As of June 30, 2024, cash, cash equivalents, restricted cash and marketable securities were $1,234.2 million as compared with $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents, restricted cash and marketable securities of $32.3 million for the six months ended June 30, 2024 was primarily related to cash used in operations of $36.0 million (net of $150.0 million received from the Novartis agreements), unrealized losses on marketable securities of $0.7 million and the purchase of lab equipment and leasehold improvements of $0.8 million, partially offset by proceeds from the exercise of stock options of $5.3 million.
Research and Development Expenses: Research and development expenses were $93.7 million for the quarter ended June 30, 2024, as compared with $103.4 million for the quarter ended June 30, 2023. The decrease in research and development expenses of $9.7 million for the quarter was primarily due to decreases in expenses related to our ER program (which includes the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer) of $6.6 million and our platform and exploratory programs of $5.7 million, partially offset by an increase in our AR program (which includes ARV-766 and bavdegalutamide (ARV-110)) of $2.6 million.
General and Administrative Expenses: General and administrative expenses were $31.3 million for the quarter ended June 30, 2024, as compared with $25.7 million for the quarter ended June 30, 2023. The increase in general and administrative expenses of $5.6 million for the quarter was primarily due to an increase in personnel and infrastructure related costs of $4.0 million and professional fees of $1.6 million.
Revenues: Revenues were $76.5 million for the quarter ended June 30, 2024, as compared with $54.5 million for the quarter ended June 30, 2023. Revenue for the quarter is related to the license agreement and the asset purchase agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, and revenue related to our Oerth Bio joint venture. The increase in revenue of $22.0 million was primarily due to revenue from the Novartis agreements, which were entered into during the quarter, of $45.4 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $22.2 million and a decrease of $1.3 million of previously constrained deferred revenue related to our Oerth Bio joint venture.
About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.
The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.
About Arvinas
Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC ® (PROteolysis Targeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102, targeting LRRK2 for neurodegenerative disorders; and ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the expected timing in connection with the completion of enrollment and readout of topline data from the VERITAC-2 clinical trial, submission of Arvinas' first new drug application filing and transition to a commercial-stage company, assuming regulatory approval, the availability and timing of data from other clinical trials, the receipt of milestone and royalty payments in connection with the transaction with Novartis and the future development, potential marketing approval and commercialization of ARV-766, the potential of Arvinas' PROTAC protein degrader platform and its potential to deliver new treatments, Arvinas' and Pfizer's plans to determine the recommended palbociclib dose to be combined with vepdegestrant in the planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer, and statements regarding Arvinas' cash, cash equivalents, restricted cash and marketable securities. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas' and Pfizer's performance of the respective obligations with respect to Arvinas' collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates and including whether Arvinas initiates and completes clinical trials for its product candidates and receive results from its clinical trials on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' and Novartis' performance of their respective obligations under the license agreement; whether Novartis will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-766; Arvinas' ability to protect its intellectual property portfolio; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other important factors discussed in the "Risk Factors" section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release.
Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com
Media:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com
| Arvinas, Inc. | ||||||
| Condensed Consolidated Balance Sheets (Unaudited) | ||||||
| (dollars and shares in millions, except per share amounts) | June 30, 2024 | December 31, 2023 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 154.8 | $ | 311.7 | ||
| Restricted cash | 5.5 | 5.5 | ||||
| Marketable securities | 1,073.9 | 949.3 | ||||
| Other receivables | 10.0 | 7.2 | ||||
| Prepaid expenses and other current assets | 12.5 | 6.5 | ||||
| Total current assets | 1,256.7 | 1,280.2 | ||||
| Property, equipment and leasehold improvements, net | 9.8 | 11.5 | ||||
| Operating lease right of use assets | 1.5 | 2.5 | ||||
| Collaboration contract asset and other assets | 11.6 | 10.4 | ||||
| Total assets | $ | 1,279.6 | $ | 1,304.6 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable and accrued liabilities | $ | 78.1 | $ | 92.2 | ||
| Deferred revenue | 267.9 | 163.0 | ||||
| Current portion of operating lease liabilities | 1.2 | 1.9 | ||||
| Total current liabilities | 347.2 | 257.1 | ||||
| Deferred revenue | 331.3 | 386.2 | ||||
| Long term debt | 0.7 | 0.8 | ||||
| Operating lease liabilities | 0.2 | 0.5 | ||||
| Total liabilities | 679.4 | 644.6 | ||||
| Stockholders' equity: | ||||||
| Preferred stock, $0.001 par value, zero shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | — | — | ||||
| Common stock, $0.001 par value; 68.6 and 68.0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 0.1 | 0.1 | ||||
| Accumulated deficit | (1,437.3 | ) | (1,332.7 | ) | ||
| Additional paid-in capital | 2,041.2 | 1,995.7 | ||||
| Accumulated other comprehensive loss | (3.8 | ) | (3.1 | ) | ||
| Total stockholders' equity | 600.2 | 660.0 | ||||
| Total liabilities and stockholders' equity | $ | 1,279.6 | $ | 1,304.6 | ||
| Arvinas, Inc. | ||||||||||||
| Condensed Consolidated Statements of Operations (Unaudited) | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| (dollars and shares in millions, except per share amounts) | 2024 | 2023 | 2024 | 2023 | ||||||||
| Revenue | $ | 76.5 | $ | 54.5 | $ | 101.8 | $ | 87.0 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 93.7 | 103.4 | 178.0 | 198.6 | ||||||||
| General and administrative | 31.3 | 25.7 | 55.6 | 50.7 | ||||||||
| Total operating expenses | 125.0 | 129.1 | 233.6 | 249.3 | ||||||||
| Loss from operations | (48.5 | ) | (74.6 | ) | (131.8 | ) | (162.3 | ) | ||||
| Interest and other income | 13.5 | 9.0 | 27.5 | 15.5 | ||||||||
| Net loss before income taxes and loss from equity method investment | (35.0 | ) | (65.6 | ) | (104.2 | ) | (146.8 | ) | ||||
| Income tax (expense) benefit | (0.2 | ) | 0.3 | (0.3 | ) | 0.7 | ||||||
| Loss from equity method investment | — | (1.3 | ) | — | (2.4 | ) | ||||||
| Net loss | $ | (35.2 | ) | $ | (66.6 | ) | $ | (104.6 | ) | $ | (148.5 | ) |
| Net loss per common share, basic and diluted | $ | (0.49 | ) | $ | (1.25 | ) | $ | (1.46 | ) | $ | (2.78 | ) |
| Weighted average common shares outstanding, basic and diluted | 71.9 | 53.4 | 71.7 | 53.4 | ||||||||
News Provided by GlobeNewswire via QuoteMedia
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces the results from its annual general and special meeting of shareholders (the "Meeting") held virtually via live audio webcast, on June 26, 2024. Shareholders voted in favour of all management resolutions proposed in the Company's management information circular dated May 13, 2024.
Resolutions proposed and approved at the Meeting were:
The election of the following directors for the ensuing year: David Elsley, Peter Pekos, Dr. Guillermo Torre-Amione, Colin Stott, Michael Willner, Jennifer Chao, Chris Waddick, Teri Loxam.
The appointment of BDO Canada LLP as auditors of the Company until the next annual meeting and the authorization of the directors of the Company to fix the remuneration to be paid to the auditors.
The approval of the unallocated awards under the Company's Omnibus Equity Incentive Plan.
The results of the voting on the election of directors are as follows:
| Nominees | Number of Shares For | Percentage of Votes Cast |
| David Elsley | 17,994,588 | 99.66% |
| Peter Pekos | 17,336,814 | 96.01% |
| Dr. Guillermo Torre-Amione | 17,345,669 | 96.07% |
| Colin Stott | 17,349,964 | 96.09% |
| Michael Willner | 17,348,726 | 96.08% |
| Jennifer Chao | 17,346,733 | 96.07% |
| Chris Waddick | 17,352,587 | 96.10% |
| Teri Loxam | 17,348,275 | 96.08% |
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/214672
News Provided by Newsfile via QuoteMedia
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the Company's virtual Annual General and Special Meeting of Shareholders (the "AGM") will be webcast on June 26, 2024, at 4:30 p.m. EDT.
Cardiol Therapeutics 2024 AGM
When: June 26, 2024, at 4:30 p.m. EDT
Where: Virtual meeting only via live audio webcast online at: web.lumiagm.com/253136217
Additional information on the AGM, including details on how to participate and vote, is available on the Company's website at cardiolrx.com/investors/events-presentations/.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/214271
News Provided by Newsfile via QuoteMedia