Company: ENTXW
Filing Date: 2025-05-09
Form Type: 10-Q
Source: 0001178913-25-001674
Chunk: 10

Company: Entera Bio Ltd.
Filing Date: 2025-05-09
Form: 10-Q
Item: Part I, Item 1
Chunk 10
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 peptide and certain oxyntomodulin (OXM) analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology. Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

                  In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology. The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
                   
                  OXM is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated safety in over 430 subjects and significant reductions in weight loss and decreased plasma triglyceride levels in over 110 subjects in completed phase 2 studies.
                     
                    In September 2024, we jointly announced with OPKO topline pharmacokinetic/pharmacodynamic (PK/PD) results for the OXM program. The program is focused on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab™ platform. Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.

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                    Additionally, in March 2025, we and OPKO entered into the 2025 Collaboration Agreement (as defined and further described below under “Recent Developments Potentially Affecting Our Business—Collaboration and License Agreement with OPKO”) with respect to the preclinical and clinical development and decision making related to the oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans.

                    Given the scarcity of oral peptide treatments and potential safety challenges