Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 48

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 48
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rilen™ (macimorelin)

Macrilen™ (macimorelin) is a novel orally available
peptidomimetic ghrelin receptor agonist that stimulates the secretion of growth hormone by binding to the ghrelin receptor (GHSR-1a)
and has potential uses in both endocrinology and oncology indications. Macrilen™ (macimorelin) was granted orphan-drug designation
by the FDA for use in the diagnosis of growth hormone deficiency (“GHD”).

Competitors for Macrilen™ (macimorelin) as
a product for the diagnosis of AGHD are principally the diagnostic tests currently performed by endocrinologists, although none of these
tests are approved by the FDA for this purpose. The most commonly used diagnostic tests for GHD are:

  The Insulin Tolerance Test (“ ITT”), which has historically                                                                               
  The Glucagon Stimulation Test (“ GST”) is considered relatively                                                                           
  The growth hormone releasing hormone-arginine stimulation test (“ GHRH                                                                    

  34  

Oral administration of Macrilen™ (macimorelin)
offers convenience and simplicity over the current GHD tests used, all of which require either IV or IM administration. Additionally,
Macrilen™ (macimorelin) may demonstrate a more favorable safety profile than existing diagnostic tests, some of which may be inappropriate
for certain patient populations (e. g. patients with diabetes mellitus or coronary heart disease) and have demonstrated a variety of side
effects, which Macrilen™ (macimorelin) has not thus far. These factors may be limiting the use of GHD testing and may potentially
enable Macrilen™ (macimorelin) to become the product of choice in evaluating AGHD. We believe that Macrilen™ (macimorelin)
is well-positioned to displace the ITT as the preferred means by endocrinologists of evaluating AGHD for the following reasons:

  it is safer and more convenient than the ITT because it does not require  
  Macrilen™ (macimorelin) is administered orally, while the ITT             
  Macrilen™ (macimorelin) is a more robust test than the ITT leading        
  Macrilen™ (macimorelin) results are highly reproducible;                  
  the evaluation of AGHD using Macrilen™ (macimorelin) is less              
  the evaluation can be conducted in the physician’s office rather          

Macimorelin