Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 47

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 47
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 without infringing
on the proprietary rights of others or have others infringe on its rights. Although the Company expends resources and efforts to patent
its discoveries and innovations, there can be no assurance that patent applications will result in the issuance of patents, or that any
patents issued to the Company will provide it with adequate protection or any competitive advantages, or that such patents will not be
successfully challenged by third parties. As an intellectual property strategy, the Company intends to prepare and file “application
patents” from the use of its products. However, the Company cannot be assured competitors will not independently develop products
similar to the Company’s Products designed to circumvent exclusive rights granted to the Company.

Pharmaceutical

The Company is also dedicated to the development
of its pharmaceutical therapeutic assets and has established a commercial and clinical development pipeline to potentially address unmet
medical needs across a number of indications, including:

  Avenanthramides                                                   
  Macrilen™                                                         

Avenanthramides for Potential Applications in
Inflammation Based Diseases

Avenanthramides have garnered significant interest
due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitroand in
vivo. In November 2023, the Company initiated its Phase 1 safety study evaluating its flagship product, avenanthramides, for potential
applications in managing conditions related to inflammation. The Phase 1-2a study (“ AvenActive”) 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. 72 healthy subjects have completed the Phase 1 portion of the trial which included 48 healthy subjects
in a single ascending dose (SAD) arm and 24 healthy subjects in a multiple ascending dose (MAD) arm.

Subjects received doses ranging from 30mg to 960mg
per group per day. Given that no significant adverse reactions have been observed during SAD and MAD phases, The Data Safety and Monitoring
Board gave the green light to start the Phase 2a with patients suffering from mild inflammation. A total of 24 patients will be enrolled
in the Phase 2a portion which is designed to gather initial insights into its potential efficacy. As the trial progresses, the Company
remains focused on collaborating with regulatory authorities, healthcare professionals, and patient communities to bring this innovative
therapy to market.

Mac