Adocia Announces Positive Topline Results of the Exploratory Phase 1b Study of ADO09 (M1Pram) in People With Type 1 Diabetes - Seite 2

In the standardized meal test in clinics at day 24, treatment with individualized doses of M1Pram resulted in a 39% decrease of the glycemic excursion vs. Novolog over the first 4 hours after the meal (primary endpoint, DeltaAUC-PG0-4h, 24±139 mg.h/dL vs 49±145 mg.h/dL, LSMratio 0.61, p=0.5). This effect and its amplitude are consistent with a significant decrease of the same parameter observed in a previous meal test of M1Pram³, as well as during the meal test administered on Day 1 of the present study (DeltaAUC-PG0-4h, -25±179 mg.h/dL vs 60±164 mg.h/dL, LSMratio -0.48, p=0.021). Additionally, the pharmacological effect of M1Pram is further confirmed by a statistically significant decrease of the glycemic excursion by more than 100% vs. Novolog over the first 2 hours after the meal (DeltaAUC-PG0-2h, -11±48 mg.h/dL vs 71±69 mg.h/dL, LSMratio -0,14, p<0.0001). The pharmacological effect of M1Pram was similar at Day 1 and Day 24, as assessed by the meal tests, demonstrating a sustained effect over three weeks.

Over the 23 days of treatment, average daily Time-in-Range (TIR, time spent within a range of blood glucose of 70-180 mg/dL), as assessed by CGM, was statistically improved for patients treated with M1Pram vs. Novolog by 5% (+51 min, p=0.013). Average daily “tight” TIR (tighter range of 80-140 mg/dL, similar to the physiological range observed in people without diabetes) was statistically improved by 14% (+70 min, p=0.002).

At the end of the treatment period, a statistically significant average weight loss of 0.7 kg compared to baseline was observed in people treated with M1Pram (p=0.012). No weight loss was observed in people treated with Novolog.

In terms of safety, both treatments were well tolerated, and no serious adverse event related to the treatments was reported. M1Pram demonstrated good local tolerance. In line with the known effects of pramlintide, gastro-intestinal side-effects were observed with M1Pram. Most of them were mild and tended to decrease after 10 days. Incidence of inpatient and outpatient hypoglycemic episodes were numerically higher, but not statistically different, in M1Pram arm compared to the Novolog arm. No severe hypoglycemic event was observed in either arm throughout the trial.