Oramed announces positive topline phase 2 results for oral insulin candidate ORMD-0801 – May 19, 2016

Oramed announced positive topline results from a phase 2b trial of its oral insulin candidate ORMD-0801. The double-blind, 28-day trial (n=180 patients with type 2 diabetes) met its unconventional primary endpoint by demonstrating a statistically significant 6.47% reduction in pooled night-time glucose (p=0.0268), as measured by a CGM, compared to placebo. The announcement stated that ORMD-0801 demonstrated a “good safety profile” in the trial with no drug-related serious adverse events. Oramed plans to present and publish the full results at a later date. We are fairly neutral on the positive topline results and will reserve enthusiasm until full results are made available as this compound has not been historically confidence-inspiring. Interpretation of previous phase 2 trials in type 1 and type 2 diabetes were hindered by small sample sizes (n=30 in type 2 and n=25 in type 1), variability in baseline insulin dose, and manufacturing malfunctions that altered the efficacy of some of the study doses. The study in type 1 diabetes also found a higher rate of hypoglycemia with ORMD-0801 than with placebo. The other main players in the oral insulin field are Novo Nordisk (candidates in phase 1 and phase 2) and Biocon (candidate in phase 1). Novo Nordisk’s success with its oral formulation of GLP-1 agonist semaglutide provides cause for optimism around oral peptide delivery. However, oral insulin is a much more challenging proposition than oral GLP-1 agonists due to the more complex dose titration requirements and narrower therapeutic window for insulin. We have just asked the company which CGM was used in the trial (out of curiosity) and will report back when we have this answer.

-- by Helen Gao, Emily Regier, and Kelly Close