Lyon, France-(Business wire)-Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris: ADOC) is a clinical stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and other metabolic disorders. Today, a Phase 2 study comparing M1 Pram and Humalog in patients with type 1 diabetes.
A fixed ratio combination of 100 units / mL of M1 human insulin analog and 600 µg / mL of pramlintide, the only FDA-approved amylin analog (Symlin)®, AstraZeneca) showed statistically superior weight loss compared to insulin lispro 100 units / mL. The full topline results will be announced in EASD2022.
“”Pramlintide is the only FDA-approved insulin adjunct for people with type 1 diabetes, so I’m really happy to see that M1 Pram ensures weight loss in overweight type 1 patients.“Adsia’s President and Chief Executive Officer, Gerard Surah, said:”Our first goal is to partner with a pharmaceutical company engaged in diabetes with this product.”
CT041 Top line results
This parallel-arm study, conducted by Profil in Germany, evaluated the efficacy, safety, and patient satisfaction of M1Pram for weight loss and glycemic control compared to insulin lispro (Humalog).®Eli Lilly) After 16 weeks of outpatient treatment in patients with type 1 diabetes with a BMI of 25-35 kg / m2.. Both products were administered at mealtime and in combination with basal insulin once daily. 71 patients completed the study.
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The 4-month weight loss of M1 Pram and Humalog is -2.13 kg (p = 0.0155) in the total population -3.1 kg (p = 0.0155) in the subpopulation of patients with BMI> 28 kg / m.2.. Continuous weight loss was observed during the period and was still ongoing at the end of the study.
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Both treatments maintained HbA1c and Time-in-Range in the patient population, with a mean HbA1c at baseline of 7.4%.
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The number of hypoglycemic events is similar between the two treatments, and there is no difference in severe hypoglycemia.
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M1Pram shows an overall excellent safety profile. The total number of adverse events (excluding hypoglycemia) M1 Pram vs Humalog, 76 vs. 38, as expected, is primarily caused by gastrointestinal side effects and is described in the pramlintide literature.
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The daily reduction in dietary insulin dose for M1Pram treatment compared to baseline was> 10% (no change in Humalog arm).
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The Treatment Satisfaction Questionnaire clearly shows that M1Pram can better control appetite for 82.4% of patients (43.2% in Humalog).
“This Phase 2 study of M1 Pram shows that a single injection at each meal is as easy and efficient as Humalog for glycemic control without increasing the incidence of hypoglycemia. increase.” Dr. Matthew Riddle, a professor of medicine in endocrinology, diabetes, and clinical nutrition at Oregon Health & Science University, declared:In addition, weight management is difficult for T1D patients and may limit glycemic control and add cardiovascular risk. M1Pram improved appetite control while reducing insulin requirements, with beneficial effects especially on the weight of obese type 1 diabetic patients. These features support the future role of this combination formulation of T1D.”
“”The results emphasize that M1Pram can provide people with type 1 diabetes with the only insulin that improves appetite control and loses weight.“Olivier Soula, Deputy CEO and R & D Director of Adocia, said:This is very encouraging and deserves a larger and longer study to fully uncover the potential of M1Pram in weight loss, HbA1c, and Time-in-Range... ”
Pramlintide is the only weight-loss product approved by the FDA as an insulin adjunct to people with type 1 diabetes. GLP1-RA is only approved for type 2 diabetes. Weight management and obesity are a major burden for people with type 1 diabetes in the United States, who are 65% overweight or obese.
About M1 Pram, an insulin / amyrin combination
M1Pram is a combination of fixed proportions of insulin and amylin analogs, two hormones that are deficient or dysfunctional in diabetics. In healthy people, insulin plays a role in hypoglycemia and glucagon acts as a hyperglycemic agent, while amylin is centrally in control of gastric emptying, well-being, and glucagon secretion. In people with type 1 diabetes, insulin and amylin are absent due to the destruction of β-cells by the immune system. In type 2 diabetes, patients gradually lose their ability to produce endogenous insulin and amylin as the disease progresses.
Pramlintide, an amylin analog, has been on the market since 2005 and when given with insulin, restores this deficient hormone, significantly improving glycemic control, weight loss in overweight patients, and health. Has been proven to be effective.
M1 Pram, as a combination of pramlintide and a fixed ratio of insulin, can reduce daily injections compared to over-the-counter pramlintide treatment schemes that require injection over insulin. In addition, M1Pram improves the safety profile of the use of pramlintide.
Based on 15 years of experience in protein preparations and diabetes, Adocia has overcome the technical challenge of co-formulating pramlintide and insulin in one product. These two hormones are usually incompatible with one formulation.
About Adoshia
Adocia is a biotechnology company specializing in the discovery and development of therapeutic solutions primarily in the areas of metabolic disorders such as diabetes and obesity. The company has a broad portfolio of candidate drugs based on three proprietary technology platforms.
1) Bio chaperone® Techniques for developing new generations of insulin and products that combine insulin with other classes of hormones. 2) AdOral®Oral peptide delivery technology; 3) AdoShell® Islets, an immunoprotective biomaterial for cell transplantation with the first application in pancreatic cell transplantation in “fragile” diabetic patients.
Adocia has more than 25 patent families.
Based in Lyon, the company has 115 employees.Adoshia is listed on EuronextTM Paris market (Euronext: ADOC; ISIN: FR0011184241).
Disclaimer
This press release contains statements regarding specific future prospects for Adoshia and its business. This forward-looking statement is based on the assumption that Adocia considers reasonable. However, there is no guarantee that the estimates contained in such forward-looking statements will be achieved. This estimate is exposed to a number of risks, including those listed in the “Risk Factors” section of the Universal Registration document submitted. Financial Institutions of Autorité des marchés in France on April 21, 2022 (a copy available at www.adocia.com), in particular the uncertainty context associated with R & D, future clinical data, analysis, and economic evolution, Financial markets and markets operated by Adocia.
The forward-looking statements contained in this press release are also exposed to risks that are not yet known to Adocia or are not considered significant by Adocia as of today. If all or part of these risks occur, Adocia’s actual results, financial position, performance, or performance may differ materially from those described in the forward-looking statements.
This press release and the information contained herein do not constitute an offer to sell or buy Adocia shares in any jurisdiction.
