REDWOOD CITY - Biomea Fusion, Inc. ('Biomea') (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the poster presentation of long-term 26 weeks follow-up data from the first two cohorts of adults with type 2 diabetes (T2D) enrolled in the ongoing Phase II clinical study (COVALENT-111) and data from preclinical ex-vivo human islet experiments of BMF-219, the company's investigational oral covalent menin inhibitor.

'Our goal with BMF-219 is to create a short-term treatment regimen for patients with diabetes that results in long term glycemic control. With the preclinical data we have published at the WCIRDC here in Los Angeles, we believe we have provided initial proof for menin's important role in diabetes, as it controls a highly relevant pathway known to reestablish beta cell health and function. We believe we have also shown that our investigational covalent agent, BMF-219, is a very targeted and effective menin inhibitor that has been generally well tolerated in our human studies to date. So far, we have only reported on patients in COVALENT-111 with our first dose of BMF-219 at 100 mg, at our first dose duration of 4 weeks. These early clinical results of improved glycemic control over time while patients are off treatment have been very impressive. Our preclinical data suggests that we should be able to improve them even further with longer dosing durations,' said Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board.

Clinical Update for COVALENT-111 at WCIRDC 2023

40 patients were enrolled in the first three Multiple Ascending Dose (MAD) cohorts of COVALENT-111, with the first cohort (Cohort 1) comprising 16 healthy volunteers (HVs); 12 HVs received 100 mg of BMF-219 once daily (QD) and 4 HVs received placebo QD for two weeks and thereafter followed off treatment for an additional six weeks. In Cohorts 2 and 3, T2D patients (n=12 per cohort with 10 patients treated with 100 mg BMF-219 QD and 2 placebo patients QD) were treated for four weeks with or without food, respectively, and then followed for 22 weeks after treatment. In these two treatment cohorts, enrolled patients had T2D diagnosed within the last 15 years, were between the ages of 18 to 65, had been treated with lifestyle management with up to three standard-of-care anti-diabetic medications, excluding sulfonylureas and insulin, with a stable dosing regimen for at least two months prior to screening, had a BMI 25 and 40 kg/m2, and had poorly controlled diabetes (HbA1c 7.0% and 10%). At baseline, diabetic patients in Cohorts 2 and 3 had a mean HbA1c of 8.0% and 8.1%, respectively.

Efficacy Data

26 Week Glycemic Data

At Week 26, 22 weeks after the last dose of BMF-219, participants in 100 mg BMF-219 QD (without food) cohort saw an improved placebo adjusted mean reduction in HbA1c of 0.8% [As reported in March 2023 at the end of the 4-week dosing period, 0.7% placebo adjusted mean reduction in HbA1c was achieved in 100 mg BMF-219 QD (without food) cohort]; Participants in 100 mg BMF-219 QD (with food) cohort saw an improved placebo adjusted mean reduction in HbA1c of 0.2% at Week 26

20% of patients from the 100mg dose cohorts displayed a reduction in HbA1c of 1% or more, compared to 0% of patients for placebo at Week 26

After only four weeks of dosing and 22 weeks off treatment, participants in BMF-219 100 mg QD without food cohort demonstrated an 80% response rate - with any reduction in HbA1c (40% response rate in 100 mg QD with food cohort)

26 Week Pharmacokinetic Data

Cohort 3 resulted in approximately 2.7-fold higher BMF-219 exposure than Cohort 2

Higher exposure resulted in greater reduction in HbA1c

Increase in mean HOMA-B and AUC C-peptide in Responders at Week 26

After 4 weeks of once daily BMF-219, responders (defined as HbA1c reduction 0.5% at Week 26) with baseline HOMA-B

(C) 2023 Electronic News Publishing, source ENP Newswire