The FDA lifted a clinical hold on two trials testing Biomea Fusion’s diabetes treatment.
The news, announced Thursday, sent the company’s shares $BMEA up by about 4% to $9.11, inching closer to its June stock price of $11.84 when the hold was first announced. At that time, the biotech said the full hold was placed due to “possible” drug-related toxicity in the liver.
Thomas Butler“We are encouraged from the safety review of the ongoing Phase 2b expansion study, where the concerning safety signals seen in the Phase 2a escalation study did not translate over to the larger expansion study,” CEO Thomas Butler said Thursday in a statement.
He said the lab results did not translate to actual liver injury or impairment. The toxicity issues arose in the dose escalation portion of the company’s Phase 1/2 COVALENT-111 trial, which is testing a menin inhibitor called BMF-219 in patients with type 2 diabetes.
Biomea said the issues could have stemmed from a number of factors, including the highest doses of the drug, food intake regimens, medical history and concomitant drugs. BMF-219 is also being tested in a Phase 1/2 study for patients with type 1 diabetes.
Biomea expects to have topline readouts from both ongoing diabetes trials, including week 26 data for around 200 patients in the type 2 diabetes study, by the end of the year. It’s also slated to have initial results from approximately 20 patients in the Phase 2a portion of the type 1 diabetes trial.
The company previously said it plans to enter the GLP-1 market, and it expects to announce an oral, small molecule candidate before the end of the year.