Photo: Exterior of FDA Maryland Headquarters/iStock, Grandbrothers
BioMare Fusion announced on Thursday that the FDA had halted all clinical trials of its drug candidates for type 1 and type 2 diabetes, causing the company’s shares to plummet more than 60% on Friday morning.
Biomere’s menin inhibitor candidate, BMF-219, is being studied in two separate Phase I/II trials for diabetes type 1 and type 2. According to Biomere, the reason for the hold is that the FDA cited deficiencies based on the level of “potential drug-induced hepatotoxicity” that was being observed during the dose-escalation phase of the type 2 diabetes trial COVALENT-111.
The biotechnology company said the high dose of the drug candidate, dietary habits, medical history and other medications during the dose-escalation phase “may have contributed to the observed elevations in liver enzymes.”
At the same time, BioMare said the majority of adverse events with BMF-219 in the COVALENT-111 and COVALENT-112 trials were “mild to moderate,” with no serious adverse reactions observed.
BioMare CEO Thomas Butler said in a statement that BMF-219 has been “generally well tolerated” so far and that based on the “totality” of the candidate’s safety and efficacy data, the company remains committed to developing the drug.
“We respect the FDA’s decision and agree that patient safety is our top priority. We are cooperating fully with the FDA and working diligently to implement plans to ensure patient safety as quickly as possible, and look forward to resuming the study as soon as we receive clearance from the FDA,” Butler said.
In March 2024, Biomare announced data from the Phase 2 COVALENT-111 trial, showing that BMF-219 improved glycemic control during a treatment break and supported improved pancreatic function after treatment. Patients who had failed current standard of care experienced a mean change in HbA1C of -0. -0.2% when taking BMF-219 with meals at 100 mg, -0.8% when taking 100 mg, and -1.4% when taking 200 mg.
In addition to diabetes clinical trials, the biotechnology company is also conducting early-stage clinical trials of BMF-219 in oncology applications, including leukemia, lymphoma, colon cancer and lung cancer.
Tyler Patchen: Bio SpaceContact him at tyler.patchen@biospace.com. Follow him on LinkedIn.
