Biomea Fusion’s Phase 1/2 covalent menin inhibitor program in diabetes has been placed on full clinical hold due to “possible” drug-related hepatotoxicity.
Liver enzyme elevations were flagged in the completed dose-escalation portion of the COVALENT-111 trial in type 2 diabetes. The combination of higher doses of up to 400 mg, different food intake schedules, patients’ medical histories and concomitant drugs may be contributing factors, the California biotech said Thursday.
Biomea’s stock $BMEA plummeted by as much as 60% in premarket trading on Friday morning.
The company reported safety data from COVALENT-111 in March. It noted that BMF-219 was well tolerated with no serious adverse events and no side effect-related discontinuations. At that time, Biomea said it was waiting for data analysis from the trial’s 400 mg cohort.
Thomas ButlerBiomea said Thursday it will continue to collect safety and efficacy data while the diabetes program is on hold. Another trial, the COVALENT-112 study, is investigating 100 mg and 200 mg doses of BMF-219 in type 1 diabetes, according to ClinicalTrials.gov.
“We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA,” CEO Thomas Butler said in a statement.
BMF-219 is an oral drug designed to improve glycemic control in diabetes patients. According to Biomea, blocking menin could help beta cells in the pancreas regenerate and proliferate, which in turn would boost insulin production.
The menin inhibitor is also under investigation in two separate Phase 1 basket cancer trials. The hematological cancer trial is a dose-escalation and dose-expansion study, while the solid tumor trial is a dose-finding investigation.
Biomea’s fifth clinical trial is looking into a different asset, named BMF-500, that acts on FMS-like tyrosine kinase 3 as a potential treatment for acute leukemia.