COSCIENS Biopharma Inc. Announces Successful Phase 1 Results Supporting Initiation of Phase 2a Clinical Efficacy Trial with Avenanthramides as a Potential Anti-Inflammatory Product
COSCIENS Biopharma (NASDAQ: CSCI) has announced successful Phase 1 results for its avenanthramides product, leading to the initiation of a Phase 2a clinical efficacy trial. The study, known as AvenActive, demonstrated no significant adverse events in Phase 1, which included 72 healthy subjects receiving doses from 30mg to 960mg per day.
The Phase 2a portion will evaluate 20 patients with mild to moderate inflammation, testing doses of 480mg and 960mg daily. The first patient treatment is scheduled for March 14, 2025, at the Montreal Heart Institute. Avenanthramides, di-phenolic compounds found exclusively in oats, have shown potential antioxidant and anti-inflammatory effects in previous studies.
The trial will assess inflammatory biomarkers in blood, including cytokines, chemokines, and high-sensitivity C-reactive protein. The company aims to pursue out-licensing opportunities and potential commercialization with a major pharmaceutical partner following the completion of Phase 2a.
COSCIENS Biopharma (NASDAQ: CSCI) ha annunciato risultati positivi della Fase 1 per il suo prodotto a base di avenantramidi, portando all'avvio di uno studio clinico di efficacia di Fase 2a. Lo studio, noto come AvenActive, non ha mostrato eventi avversi significativi nella Fase 1, che ha incluso 72 soggetti sani a cui sono state somministrate dosi da 30mg a 960mg al giorno.
La parte di Fase 2a valuterà 20 pazienti con infiammazione da lieve a moderata, testando dosi di 480mg e 960mg al giorno. Il primo trattamento del paziente è previsto per il 14 marzo 2025, presso l'Istituto Cardiologico di Montreal. Le avenantramidi, composti di di-fenolo presenti esclusivamente nell'avena, hanno mostrato potenziali effetti antiossidanti e anti-infiammatori in studi precedenti.
Il trial valuterà i biomarcatori infiammatori nel sangue, inclusi citochine, chemokine e proteina C-reattiva ad alta sensibilità. L'azienda mira a perseguire opportunità di licenza e potenziale commercializzazione con un importante partner farmaceutico dopo il completamento della Fase 2a.
COSCIENS Biopharma (NASDAQ: CSCI) ha anunciado resultados exitosos de la Fase 1 para su producto de avenantramidas, lo que lleva al inicio de un ensayo clínico de eficacia de Fase 2a. El estudio, conocido como AvenActive, no mostró eventos adversos significativos en la Fase 1, que incluyó a 72 sujetos sanos que recibieron dosis de 30mg a 960mg por día.
La parte de Fase 2a evaluará a 20 pacientes con inflamación leve a moderada, probando dosis de 480mg y 960mg diarios. El primer tratamiento del paciente está programado para el 14 de marzo de 2025, en el Instituto Cardiaco de Montreal. Las avenantramidas, compuestos di-fenólicos que se encuentran exclusivamente en la avena, han mostrado efectos antioxidantes y antiinflamatorios potenciales en estudios anteriores.
El ensayo evaluará biomarcadores inflamatorios en sangre, incluidos citoquinas, quimioquinas y proteína C-reactiva de alta sensibilidad. La empresa tiene como objetivo buscar oportunidades de licencias y comercialización potencial con un importante socio farmacéutico tras la finalización de la Fase 2a.
COSCIENS Biopharma (NASDAQ: CSCI)는 아베난트라미드 제품의 1상 시험에서 성공적인 결과를 발표하며 2a상 임상 효능 시험을 시작한다고 밝혔습니다. AvenActive로 알려진 이 연구는 30mg에서 960mg까지의 용량을 받는 72명의 건강한 피험자를 포함한 1상에서 유의미한 부작용이 없음을 보여주었습니다.
2a상 부분에서는 경증에서 중등도의 염증이 있는 20명의 환자를 평가하며, 하루 480mg 및 960mg의 용량을 시험합니다. 첫 번째 환자 치료는 2025년 3월 14일 몬트리올 심장 연구소에서 예정되어 있습니다. 아베난트라미드는 귀리에서만 발견되는 디페놀 화합물로, 이전 연구에서 잠재적인 항산화 및 항염 효과를 보여주었습니다.
이 시험은 혈액 내 염증 바이오마커를 평가할 것이며, 여기에는 사이토카인, 케모카인 및 고감도 C-반응성 단백질이 포함됩니다. 회사는 2a상 완료 후 주요 제약 파트너와의 라이선스 기회 및 상용화를 추구할 계획입니다.
COSCIENS Biopharma (NASDAQ: CSCI) a annoncé des résultats positifs de la Phase 1 pour son produit à base d'avénanthramides, conduisant au lancement d'un essai clinique d'efficacité de Phase 2a. L'étude, connue sous le nom d'AvenActive, n'a montré aucun événement indésirable significatif lors de la Phase 1, qui a inclus 72 sujets sains recevant des doses de 30mg à 960mg par jour.
La partie de la Phase 2a évaluera 20 patients présentant une inflammation légère à modérée, testant des doses de 480mg et 960mg par jour. Le premier traitement du patient est prévu pour le 14 mars 2025, à l'Institut Cardiaque de Montréal. Les avénanthramides, des composés di-phénoliques présents exclusivement dans l'avoine, ont montré des effets antioxydants et anti-inflammatoires potentiels dans des études antérieures.
L'essai évaluera les biomarqueurs inflammatoires dans le sang, y compris les cytokines, les chimiokines et la protéine C-réactive à haute sensibilité. L'entreprise vise à rechercher des opportunités de licence et une commercialisation potentielle avec un grand partenaire pharmaceutique après l'achèvement de la Phase 2a.
COSCIENS Biopharma (NASDAQ: CSCI) hat erfolgreiche Ergebnisse der Phase 1 für sein Avenanthramide-Produkt bekannt gegeben, was zur Einleitung einer klinischen Wirksamkeitsstudie der Phase 2a führt. Die Studie, bekannt als AvenActive, zeigte in Phase 1 keine signifikanten unerwünschten Ereignisse, die 72 gesunde Probanden umfasste, die Dosen von 30mg bis 960mg pro Tag erhielten.
Der Teil der Phase 2a wird 20 Patienten mit leichter bis moderater Entzündung bewerten und Dosen von 480mg und 960mg täglich testen. Die erste Patientenbehandlung ist für den 14. März 2025 am Montreal Heart Institute geplant. Avenanthramide, di-phenolische Verbindungen, die ausschließlich in Hafer vorkommen, haben in früheren Studien potenzielle antioxidative und entzündungshemmende Effekte gezeigt.
Die Studie wird entzündungsbezogene Biomarker im Blut bewerten, darunter Zytokine, Chemokine und hochsensitives C-reaktives Protein. Das Unternehmen zielt darauf ab, nach Abschluss der Phase 2a Lizenzierungsmöglichkeiten und potenzielle Kommerzialisierung mit einem großen Pharmaunternehmen zu verfolgen.
- Successful completion of Phase 1 trial with no significant adverse events
- Phase 2a trial approved to proceed based on positive safety data
- Clear development pathway with defined dosing ranges (480mg and 960mg)
- Partnership potential with major pharmaceutical companies
- Early-stage development with efficacy yet to be proven
- Small patient sample size (20) for Phase 2a trial
- Commercial success dependent on future partnership agreements
Insights
COSCIENS Biopharma's announcement represents a significant clinical milestone with the successful completion of their Phase 1 trial and advancement to Phase 2a for their avenanthramide product. The company has demonstrated a favorable safety profile with no significant adverse events across 72 healthy subjects who received doses ranging from
This progression to Phase 2a efficacy testing substantially de-risks the early clinical development pathway, though it's important to recognize that efficacy remains unproven at this stage. The upcoming trial involving 20 patients with mild to moderate inflammation will assess potential anti-inflammatory activity at doses of
The involvement of the Montreal Heart Institute and Dr. Jean-Claude Tardif, a respected cardiovascular researcher, suggests potential applications in cardiovascular inflammation, though specific indications remain undefined. This collaboration adds scientific credibility to the program.
The company's strategic positioning of this natural compound with pharmaceutical-grade development standards appears designed to attract potential licensing partners. Management clearly views this asset as potentially transformative, likely due to the growing market interest in natural anti-inflammatory compounds with favorable safety profiles.
While this news demonstrates meaningful pipeline progress, investors should maintain measured expectations regarding timeline to market and ultimate commercial potential, as substantial clinical and regulatory hurdles remain before commercialization becomes possible.
The advancement of COSCIENS' avenanthramide program from Phase 1 to Phase 2a represents a classic de-risking event in pharmaceutical R&D. The clean safety profile across multiple ascending dose cohorts removes a important early hurdle in drug development, particularly important for natural compounds where establishing a formal pharmacokinetic profile can be challenging.
The pharmacokinetic data established in Phase 1 has enabled rational dose selection for efficacy testing, with the higher range doses (
Mechanistically, avenanthramides' potential to modulate pro-inflammatory gene expression and cytokine production aligns with current understanding of inflammation biology. The emphasis on biomarker assessment in Phase 2a, including cytokines, chemokines, and high-sensitivity C-reactive protein, provides a scientifically sound approach to detecting anti-inflammatory activity before pursuing larger indication-specific trials.
The company's methodical approach—applying rigorous pharmaceutical development standards to a naturally-derived compound—differentiates this program from typical nutraceutical development. This pharmaceutical-grade development strategy enhances partnership potential with larger pharmaceutical companies who require robust clinical data.
While the small Phase 2a sample size (20 patients) indicates this is primarily a signal-finding study, positive biomarker results could accelerate development in specific inflammatory conditions. The initiation of patient dosing on March 14 suggests efficient clinical operations and trial execution.
- No significant clinical adverse event observed in Phase 1clinical study
- Pharmacokinetic profile established and range of doses selected for Phase 2a Clinical Efficacy Study
- First patient expected to be treated in the Phase 2a Clinical Efficacy Study on March 14, 2025 at the Montreal Heart Institute
TORONTO, ONTARIO, March 13, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced Initiation of its Phase 2a clinical efficacy study of its flagship avenanthramides product being developed for potential applications in managing conditions related to inflammation.
Avenanthramides are di-phenolic compounds found exclusively in oats. They have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitro and in vivo.
The Company initiated a clinical trial (Phase 1-2a) in November 2023 referred to as the AvenActive study. That trial is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of the Company’s avenanthramide product. A total of 72 healthy subjects have completed the Phase 1 portion of the AvenActive study which included 48 healthy subjects in a single ascending dose (SAD) arms and 24 healthy subjects in multiple ascending dose (MAD) arms. Subjects received doses ranging from 30 mg to 960 mg per group per day. No significant adverse events were reported during the Phase 1 portion of the AvenActive study.
Given the favorable safety profile of the Company’s avenanthramide product seen to date in the AvenActive study, the Data Safety and Monitoring Board recommended the Phase 2a portion of the AvenActive study be initiated with patients presenting evidence of mild to moderate inflammation. A total of 20 patients will be enrolled in the Phase 2a portion of the AvenActive Study which is designed to assess potential efficacy in two arms with patients receiving selected doses of 480 mg and 960 mg per day. Dr.Tardif’s team at the Montreal Heart Institute has already recruited the first patients and initial dosing is expected to occur on March 14, 2025.
Dr. Jean-Claude Tardif, principal investigator of the study and Director of the Research Center at the Montreal Heart Institute, stated, "The Phase 1 portion of the AvenActive study has been very encouraging, demonstrating an excellent safety profile with no significant adverse events to date. With these positive results, we are now enthusiastically advancing into Phase 2a to assess whether the Company’s avenanthramide product exhibit signs of activity in subjects with low-grade inflammation. The findings from this next phase could provide critical insights into the potential role of avenanthramides in reducing vascular inflammation and improving cardiovascular health."
Published data suggests that polyphenols like avenanthramides may influence signal transduction pathways and exhibit anti-inflammatory effects. They modulate pro-inflammatory gene expression, including key cytokines and enzymes. The AvenActive study will assess inflammatory biomarkers in blood, focusing on cytokines, chemokines, and high-sensitivity C-reactive protein.
"COSCIENS Biopharma is advancing this groundbreaking research with a natural product with the highest scientific rigor. The successful completion of Phase 1 clinical study represents a critical milestone for this biopharmaceutical development program. With Phase 2a now launched, we believe we are strategically positioned to seek potential out-licensing opportunities and future commercialization with a major pharmaceutical partner. Given its significant therapeutic and market potential, we believe our avenanthramide product could become a transformative product for COSCIENS which aspires to become a global leader in natural-based products for health and wellness,” concluded Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS Biopharma.
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the Université de Montréal and has more than 2000 employees, including 245 physicians and more than 85 researchers. For more information, please visit https://www.icm-mhi.org/en. The Montreal Health Innovations Coordinating Center (MHICC) is a leading full-service academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing (https:/www.mhicc.org).
About COSCIENS Biopharma Inc.
COSCIENS is a life science company resulting from the merger of Aeterna Zentaris and Ceapro Inc. COSCIENS develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. We are focused on leveraging our proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt's Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals.
The Company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol "CSCI". For more information, please visit COSCIENS' website at www.cosciensbio.com.
Forward-Looking Statements
Certain statements in this news release, referred to herein as "forward-looking statements", constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and "forward-looking information" under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as "anticipate", "assume", "believe", "could", "expect", "forecast", "future", "goal", "guidance", "intend", "likely", "may", "would" or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release include, but are not limited to, statements relating to: our goals and expectations regarding our plans related to the potential to develop, out-license and/or commercialize our avenanthramide product, the potential outcome of the AvenActive study and the ability of our avenanthramide product could become a transformative product for COSCIENS, our plans to drive revenues from our products, our expectation we have the potential to become a global leader in natural-based products for health and wellness.
Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them.
Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the combined Company's present and future business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products, product development and related clinical trials and validation studies; results from our avenanthramide product and other products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in CGHD may impact the market for macimorelin (Macrilen®; Ghryvelin®) in AGHD and the existing relationships we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on sales by and revenue from our main distributor of our legacy Ceapro products and its customers, the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; and our ability to continue to list our common shares on the NASDAQ Capital Market.
Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this news release.
Issuer:
Gilles R. Gagnon
President & CEO
+1 (780) 421-4555
E: ggagnon@cosciensbio.com
Investor Contact:
Jenene Thomas
JTC TeamT (US): +1 (908) 824-0775
E: csci@jtcir.com
FAQ
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