- In Cohort 3, after 4 weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c.
- Initial observations of continued glycemic control were seen in follow up visits in patients that had already reached week 8 in the study (4 weeks after the last BMF-219 dose) at the time of this publication.
- BMF-219 demonstrated a well-tolerated safety profile. No patients on BMF-219 discontinued dosing and all patients completed 4 weeks of treatment.
- Biomea continues dose escalation of BMF-219 in COVALENT-111 and plans to explore additional dosing periods greater than 4 weeks in order to evaluate the optimal duration of glycemic control.
- Biomea plans to explore the potential clinical utility of BMF-219 in other diabetic patient populations, including type 1 diabetes.
- Biomea to host conference call on Tuesday, March 28th at 8:30 AM EDT.
REDWOOD CITY, Calif., March 28, 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 initial positive topline data for the first two cohorts of patients with type 2 diabetes mellitus (T2DM) enrolled in the Phase II portion of its ongoing Phase I/II clinical study (COVALENT-111) of BMF-219, the company’s novel, investigational covalent menin inhibitor.
Beta cell loss has been observed to be a critical component of the etiology and pathogenesis of both type 2 and type 1 diabetes; menin is thought to be a key inhibitory regulator that limits beta cell recovery in the pancreas. Using its proprietary FUSION™ System, Biomea designed BMF-219 to specifically inhibit menin to release the brakes on beta cells, and potentially enable their regeneration, reactivation, and preservation. This is the first clinical observation of patients with diabetes having a robust glucose-lowering response driven by an investigational menin inhibitor with a potentially disease-modifying mechanism of action, which may allow for continued glycemic control for prolonged periods even after treatment is stopped.
“Our goal with BMF-219 is to deliver the first disease-modifying treatment for patients with diabetes by addressing the root biological cause of the disease and its inevitable progression: the loss of insulin-producing beta cells. Today, we are seeing indications that we are achieving that goal and that BMF-219 may indeed be capable of regenerating, preserving, and reactivating healthy, functional beta cells. Moreover, we are seeing this impact and high level of glycemic control after just 4 weeks of treatment, a remarkably short timeframe, and at the first dose level, with highly favorable safety and tolerability,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “More than 50% of the 27 million patients in the US diagnosed with type 2 diabetes have an A1c higher than 7%, indicating that their current treatments are not able to control their disease and their increased sugar levels may lead to harming their organs. With BMF-219, we believe we have the potential to radically transform the treatment of type 2 diabetes and help millions of patients – and these initial data certainly support that belief and excitement.”
Mr. Butler continued, “We are now exploring the various dose levels in the escalation portion of the study and will select the two most promising dose levels, to investigate the treatment length and with the goal of optimizing treatment responses and durability for the majority of diabetes patients. Importantly, these initial data also give us the confidence to continue our plans to move forward with evaluating BMF-219 as a potential treatment for patients with type 1 diabetes. This is an exciting day for the Biomea team, but most importantly an exciting day for patients with diabetes.”
Dr Jose E. Rodriguez, Internal Medicine & Medical Director at the Southwest General Healthcare Center (Fort Myers, Florida), a treating physician in COVALENT-111, added, “my patients had great benefits being included in COVALENT-111. The study drug showed hardly any side effects and was easily accepted. My patients are seeing positive health improvements, and I can literally say they are generally feeling better, overall happy and are enthusiastic, with more energy than they had before they started the study.”
Preliminary Clinical Data
40 patients were enrolled in the first three cohorts of COVALENT-111, with the first cohort (Cohort 1) comprising 16 healthy volunteers (HVs); 12 HVs were exposed to 100 mg BMF-219 once daily (QD) for two weeks and 4 HVs were exposed to placebo. In Cohorts 2 and 3, T2DM patients (n=12 per cohort with 10 patients treated with BMF-219 and 2 patients on placebo) received BMF-219 once daily for 4 weeks with or without food, respectively. In the two active treatment cohorts, enrolled patients had T2DM diagnosed for 0.5% reduction in A1c
- 30% of patients achieved a >0.5% to