Mr. Gilles Gagnon reports

CEAPRO INC. INITIATES PHASE 1-2A STUDY ASSESSING ITS FLAGSHIP PRODUCT AVENANTHRAMIDES FOR POTENTIAL APPLICATIONS IN INFLAMMATION BASED DISEASES

Ceapro Inc. has initiated its phase 1 study evaluating its flagship product, avenanthramides, for potential applications in managing conditions related to inflammation.

Avenanthramides, di-phenolic compounds found exclusively in oats, have garnered significant interest due to their suggested bioactivities, including potent anti-oxidant and anti-inflammatory effects both in vitro and in vivo.

This phase 1-2a study 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 avenanthramide. Seventy-two healthy subjects will be enrolled in the phase 1 portion of the trial. The single ascending dose (SAD) arm will include six cohorts of eight healthy subjects, while the multiple ascending dose (MAD) arm will include three cohorts of eight healthy subjects. Following the phase 1 portion, pending successful results, the AvenActive protocol also includes a phase 2a portion for patients presenting evidence of mild to moderate inflammation. Twenty-four patients would be enrolled in the phase 2a portion. Dr. Jean-Claude Tardif's team is now actively screening healthy subjects for the first SAD cohort. Subjects will be under observation in a clinical setting and initial dosing is anticipated in early December, 2023.

Dr. Tardif, the principal investigator of the study and director of the research centre at the Montreal Heart Institute, stated: "We are excited to explore the potential therapeutic benefits of avenanthramides and believe results from this study could mark a significant step forward in understanding the potential of avenanthramides in cardiovascular disease. Not only will the study assess safety of avenanthramides in healthy subjects, but it could also provide early signs of activity in subjects with low-grade inflammation as part of the phase 2a component. The results of such studies will provide valuable insights into the potential role of avenanthramides in reducing vascular inflammation and may have implications for cardiovascular health."

Published data have indicated that polyphenols, such as avenanthramides, may act as modifiers of signal transduction pathways, exhibiting beneficial effects. These natural compounds are known to express anti-inflammatory activity by modulating the expression of pro-inflammatory genes, including cyclo-oxygenase, lipoxygenase, nitric oxide synthases and key cytokines. The AvenActive study will focus on evaluating biomarkers of inflammation in blood, with a particular emphasis on pro-inflammatory cytokines, chemokines and other inflammatory markers such as high sensitivity C-reactive protein.

"Ceapro is thrilled to advance this groundbreaking research. A number of studies have suggested that avenanthramides may exert anti-inflammatory effects on the vascular system through various mechanisms and we look forward to better decipher those pathways. Initiation of this study marks another step in expanding our business as a biopharmaceutical company. Pending successful results in the phase 1 and potential phase 2a study, we believe we will be well positioned for outlicensing opportunities for later stage development and commercialization. With significant market potential and patient benefit, we believe avenanthramides is poised to be the biggest product for Ceapro," concluded Gilles Gagnon, MSc, MBA, president and chief executive officer of Ceapro.

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, ultraspecialized care, professional training and prevention. It houses the largest cardiology research centre in Canada, the largest cardiovascular prevention centre in the country and the largest cardiovascular genetics centre in Canada. The institute is affiliated with the Universite de Montreal and has more than 2,000 employees, including 245 physicians and more than 85 researchers. 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 4,500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials and drug repurposing.

About Ceapro Inc.

Ceapro is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and active ingredients from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical and therapeutics products for humans and animals. The company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.