BMEA - Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26 after BMF-219's 28-Day Treatment Cycle Supporting Improved Pancreatic Function | Benzinga
Three Clinical Data Sets from the Dose Escalation Phase of COVALENT-111 to be Presented at the 17th Annual ATTD Conference Highlighting BMF-219's Novel Mechanism of Action in Patients with Type 2 Diabetes
- Patients in COVALENT-111 are displaying improved glycemic control while off therapy out to Week 26 following the 28-day treatment with BMF-219, supporting enhanced pancreatic islet function as the mechanism of action
- BMF-219 was generally well tolerated with no serious adverse events and no adverse event-related study discontinuations, and no symptomatic or clinically significant hypoglycemia
- 100mg and 200mg dose levels have been selected for the first 3 Arms of the Expansion Phase, which will dose patients up to 12 weeks (compared to 4 weeks in the Escalation Phase) and extended follow-up to Week 52
- The Expansion Phase of COVALENT-111 is currently enrolling on schedule with initial 26-week data expected during 2H24
- Biomea Fusion to announce an update on the first two patients with Type 1 Diabetes, from the COVALENT-112 Study, in the Q4 2023 Earnings Release
REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024. This clinical data from all dosing cohorts initiated to date as of February 12, 2024 from the Escalation Phase of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD. Biomea will showcase the following three e-poster presentations:
- Durable Glycemic Control with BMF-219 During Off-Treatment Period at Week 26: A Phase 1/2 Trial of BMF-219 in Patients with Type 2 Diabetes (COVALENT-111) (Poster Discussion Session, March 7th, 10-10:30 am CET.)
- Case Studies from COVALENT-111, A Phase 1/2 Trial of BMF-219, a Covalent Menin Inhibitor, in Patients with Type 2 Diabetes (Poster Viewing Session)
- Key Observations from the Dose Escalation Portion of COVALENT-111, a Phase 1/2 Trial of the Covalent Menin Inhibitor BMF-219 in Patients with Type 2 Diabetes (Poster Viewing Session)
All e-Posters will be available for viewing through the conference virtual platform once the conference commences. Please find a link here to our website where the poster presentations and discussion will be available.
"We aim to cure diabetes and believe we are on the path to do so. Notably, after receiving a short, 4-week course of BMF-219, patients with type 2 diabetes are displaying durable glycemic control, and in some cases displaying continued improvement in glycemic control while off therapy. The Escalation Phase of our first in human study was quite successful, generating strong clinical data with a novel mechanism of action and importantly providing us with proof-of-concept data to support the design of the Expansion Phase which is now enrolling. The Expansion Phase will dose patients for longer treatment periods with the goal of broadening and deepening BMF-219's effect across the type 2 patient population. As presented at the ATTD conference, we believe the observations from biomarkers including HbA1c, HOMA-B, and C-peptide analysis for responders vs. non-responders, together with pharmacokinetic dose response data all point to strong evidence that BMF-219 is specifically proliferating beta cells in pancreatic islets of uncontrolled type 2 diabetes patients," said Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board. "I am also excited about the potential this pathway may provide patients with type 1 diabetes. We are enrolling our open label arm (n=40) of our Phase II COVALENT-112 study in adults with stage 3 type 1 diabetes first which will give us initial response data before embarking on a larger, potentially registrational study."
Data Highlights from ATTD Presentations
Efficacy Findings
- Patients in COVALENT-111 are displaying improved glycemic control while off therapy, supporting improved pancreatic function following BMF-219 treatment. Patients who demonstrated the greatest HbA1c reduction at Week 26 (22 weeks off treatment), had the greatest improvement in beta cell function as ...