(BFM Bourse) – A clinical trial has shown that Adocia’s “M1Pram” compound, which combines amylin with insulin (two hormones lacking in type 1 diabetic patients, “innate” diabetes), led to weight loss average of more than 2 kgs and better appetite control, compared to insulin alone.
“Luck, you see… it doesn’t exist”, as François Capella (played by Belmondo) declared to Roch Siffredi (Delon) in the final scene of Borsalino, Jacques Deray’s seminal film released in 1970. Bad luck , it is perhaps at work in any case for Adocia this Wednesday. The Lyon-based biotechnology company specializing in diabetes treatments saw its 5.9% rise at the opening turn into a decline of almost 4% in the afternoon, the general decline in the market taking precedence over the announcement of the success of a phase 2 trial on its compound M1Pram.
In people with type 1 diabetes, called insulin-dependent diabetes (or even “innate” compared to diabetes of middle age, type 2), the liver does not secrete this famous insulin, the hormone allowing the absorption of glucose from food and for a hundred years now, the treatment strategy has been based on the addition of different forms of insulin. But it is unfortunately not the only hormone insufficiently or not secreted in these patients. Lack of amylin is also detrimental in diabetics because of its central role in controlling gastric emptying. The duration of digestion is reduced (the pylorus opens too early), leading to digestive difficulties, a lack of satiety leading to cravings for snacking and therefore a risk of overweight (65% of T1 diabetics are affected in the States States) and a range of comorbidities.
Since 2005 an amylin analogue, pramlintide, has been marketed by AstraZeneca under the brand name Symlin. Restoring this missing hormone has dramatically beneficial effects: improved glycemic control, weight loss in overweight patients, and improved overall well-being. It is now the only weight loss product approved by the FDA as an insulin adjuvant for people with type 1 diabetes.
But the problem is that insulin and pramlintide are not compatible (differences in stability and solubility profiles) in the same formulation… which implies that the patient adds three additional injections per day in addition to (at least ) four injections of insulin, a chore that makes compliance with the treatment very difficult in practice.
With M1Pram, resulting from its 15 years of experience in the formulation of proteins and more particularly in the field of diabetes, Adocia is the only one to have overcome the technical challenge of combining pramlintide (analog of amylin) with insulin in a single injection compound. And a trial conducted in Germany by Profil, a specialized company, with 71 patients showed that the administration of M1Pram resulted in an average weight loss of -2.13 kg (p-value of 0.0045) over 4 months compared to insulin lispro (Humalog from Eli Lilly in this case), and even -3.1 kg (p value of 0.0155) on average among patients suffering from greater overweight (BMI of more than 28 kg/m2 A continuous decrease in weight was observed over the period, and was still ongoing at the end of the study.
Assessed by a patient questionnaire, the M1Pram combo also clearly showed better appetite control (82.4% of patients versus 43.2% with Humalog). In addition, patients in the M1Pram group were also able to benefit from a reduction of more than 10% in the daily dose of prandial insulin compared to the starting dose, whereas no change was observed in the arm of insulin alone.
In terms of glycemic control (maintenance of HbA1c level and therapeutic “time in target”) the experimental treatment of Adocia was shown to be equivalent to insulin, without increasing the rate of hypoglycemia, underlined Dr. Matthew Riddle, Professor of Medicine in the Division of Endocrinology, Diabetes & Clinical Nutrition at Oregon Health & Science University. “In addition, being overweight has a potentially deleterious effect on glycemic control, it increases cardiovascular risk and represents a therapeutic challenge for type 1 diabetic patients. While reducing the need for insulin, M1Pram improves appetite control and has beneficial effects on weight, especially in type 1 diabetic patients with obesity. These characteristics confirm the role of this combination for type 1 diabetics in the future”, indicated the practitioner.
For people with type 1 diabetes, M1Pram could become “the only insulin that improves appetite control and reduces weight”, said Olivier Soula, deputy CEO and R&D manager of Adocia. “This is very encouraging and motivates a larger, longer study to uncover the full potential of M1Pram for weight loss, HbA1c control and time to target therapy.” A study that the company is seeking to have financed by an industrial partner, the first objective now being to license the product to a major player in diabetes.
Guillaume Bayre – ©2022 BFM Bourse
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