US FDA lifts clinical hold on Biomea's diabetes trials after safety review

By Puyaan Singh

(Reuters) -The U.S. Food and Drug Administration lifted a clinical hold on Biomea Fusion's ongoing studies of its experimental drug for type 1 and type 2 diabetes, the drug developer said on Thursday.

The regulator had placed a hold on two trials of its lead drug, BMF-219, in June due to liver toxicity concerns. Biomea's shares have declined 22% since, but closed 9.1% higher at $9.57 on Thursday.

The drug is being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study for type 1 diabetes.

Biomea said the FDA conducted a safety review of an "expanded" ongoing study for the drug. Data from this study did not show any concerning safety signals seen earlier in type 2 diabetes patients, who received progressively higher doses.

CEO Thomas Butler said on a call with investors that high levels of liver enzymes occurred in the first 30 days in patients who started treatment with a 200 milligram dose.

"These patients typically had high baseline blood glucose levels and experienced a rapid drop in their blood sugar," he said.

Patients who started with a 100 milligram dose and were progressed to 200 milligrams after 60 days did not experience high levels of liver enzymes, Biomea said.

"FDA has recommended and we have implemented a single step (dose) escalation ... and increased monitoring (of patients)," said Biomea's medical chief Juan Pablo Frías.

Frías added that a vast majority of patients on the highest 400 milligram dose did not discontinue treatment.

Biomea said that the FDA recommended patients who were on certain antibiotics to be excluded from studies, or wait until their antibiotic course was completed.

BMF-219 works by increasing, preserving and reactivating patients' own healthy insulin-producing cells.

Biomea expects to release initial data from its type 1 diabetes trial and from an expansion phase of the type 2 diabetes study in the fourth quarter.

(Reporting by Puyaan Singh in Bengaluru; Editing by Alan Barona)