Adocia Announces Positive Topline Results of the Exploratory Phase 1b Study of ADO09 (M1Pram) in People With Type 1 Diabetes

Regulatory News:

ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC, ­the “Company”), the biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of proteins and peptides, announced today positive preliminary results of a Phase 1b study of M1Pram (“ADO09”), a ready-to-use, fixed ratio co-formulation of pramlintide (Symlin, AstraZeneca), the only FDA-approved analog of amylin, and A21G human insulin analog (“M1”), a mealtime insulin with a similar time-action profile to human insulin and also the main circulating metabolite of insulin glargine. M1Pram is intended as a replacement to prandial insulin therapy; in enabling the combination of two complementary hormones, it aims to improve post-meal glucose control and long-term outcomes.

“Remarkably, after only three weeks of treatment with M1Pram, all known pharmacological effects of pramlintide were observed in this clinical trial in people with type 1 diabetes,” said Prof. Thomas Pieber, Professor of Medicine at the Medical University of Graz, Austria. “This trial confirmed the strong reduction of the postprandial glucose excursion previously observed in a clinical trial with M1Pram. Furthermore, the outpatient period showed improvement in time in target glycemic range without increasing the risk of hypoglycemia, as well as an improvement in weight control, two key medical benefits for people with type 1 diabetes.”

“We are pleased to be able to share the impressive results of this exploratory study, which confirm the strong potential of M1Pram to improve the lives of people with type 1 diabetes, by delivering a significant benefit over the standard of care in insulin therapy while also removing the burden of additional injections,” commented Olivier Soula, Director of R&D and Deputy CEO. “The positive results obtained across multiple endpoints motivated us to rapidly advance this program to a three- month, Phase 2 study. Additionally, the US patent for M1Pram was recently granted, which protects our pioneering position in the field in this territory.”

This randomized, double-blind, active-controlled, 2 period cross-over clinical trial aimed to assess the safety and efficacy of M1Pram. 24 subjects with type 1 diabetes received multiple daily doses of M1Pram and Novolog (insulin aspart, Novo Nordisk) over two periods of 24 days each (including 4 days in the clinic and 20 outpatient days), following a run-in period to optimize basal insulin regimen. Subjects received an open continuous glucose monitoring (CGM) system which was used for safety and efficacy assessment throughout trial participation. At day 1 and day 24, pharmacokinetic, pharmacodynamic and gastric emptying profiles were measured after bolus injections of M1Pram or Novolog, administered immediately before a standardized mixed meal. The primary objective was to compare post-meal glucose profiles at day 24. Additionally, the study documented the safety and efficacy of M1Pram in an outpatient setting, as well as plasma glucose control as assessed by CGM over the entire period.