Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 Demonstrated a 90% Response Rate and 70% Maintained or Improved Time in (Normal Glucose) Range, While Off-Treatment
- Eight weeks after completing treatment with BMF-219, patients with type 2 diabetes (T2D) showed an increase of C-peptide and an improvement of HOMA-B, measured during oral glucose tolerance testing (OGTT), supporting improved beta cell function for these patients
- Observations of durable and continued improvement in glycemic control were seen in follow-up visits through Week 12 compared to Week 4, eight weeks after the last dose of BMF-219:
- 70% of Cohort 3 (n=10) patients (100 mg BMF-219 without food) maintained or improved their time in range during continuous glucose monitoring (CGM), while off treatment
- 50% of Cohort 3 patients showed continued improvement in their HbA1c levels while being off treatment through Week 12
- 50% of Cohort 3 patients saw a continued mean reduction in HbA1c of 1.49% at Week 12, an additional 62% reduction compared to the mean reduction of 0.9% at the end of the 4-week dosing period
- Target HbA1c of ≤7% achieved by 60% of subjects in Cohort 3 at the end of Week 12, compared to 30% at the end of dosing period (Week 4) and 10% at the end of Week 1
- Biomea to host a conference call on Monday, June 26th at 8:30 AM ET
REDWOOD CITY, Calif., June 23, 2023 (GLOBE NEWSWIRE) -- 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 presentation of new clinical data from the first two cohorts of patients with T2D enrolled in the Phase II portion of its ongoing Phase I/II clinical study (COVALENT-111) of BMF-219, the company’s investigational oral covalent menin inhibitor.
Beta cell loss is a critical component of the etiology and pathogenesis of both type 2 and type 1 diabetes; menin is thought to function as a key regulator of beta cell mass and health in the pancreas. BMF-219, discovered and designed by Biomea using its FUSION™ platform to specifically inhibit menin, has shown in pre-clinical studies three modes of action: the regeneration, reactivation, and preservation of functional beta cells. This is the first clinical observation of an investigational menin inhibitor dosed in patients with diabetes, showing continued improvements in glycemic control after cessation of therapy. Along with safety and efficacy, COVALENT-111 is evaluating BMF-219’s disease-modifying potential, which has now shown initial proof of concept for continued glycemic control even after treatment is stopped.
“The data released at the ADA Scientific Sessions is a significant milestone for Biomea and for patients with diabetes as it further supports BMF-219’s ability to address a root cause of the disease, beta cell loss. Patients achieved an improvement in glycemic control even after dosing of BMF-219 has stopped, which we believe is caused by an improvement in pancreatic islet function through the disruption of menin. These landmark findings support the potential disease-modifying impact of BMF-219,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “This is the first time an investigational agent for the treatment of diabetes has resulted in an increase in levels of C-peptide that is maintained after the treatment has stopped. These historic data support our goal for BMF-219 to become the first disease-modifying treatment for patients with diabetes. We are working to address an underlying biological cause of the disease and its inevitable progression: the loss and decrease in function of insulin-producing beta cells. Today, we have shared additional early observations from our ongoing clinical trial – COVALENT-111. What is particularly exciting is that we are seeing this impact and glycemic control after just four weeks of treatment, a short timeframe, and at the first dose level of BMF-219 with encouraging tolerability data. We are evaluating additional dose levels and will also test various dosing durations to explore these potential benefits in the largest possible patient population. Diabetes is a heterogenous disease, we are excited to explore where BMF-219 may have the biggest impact for patients.”
Late Breaking Clinical Update for COVALENT-111 at ADA 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 for