Biomea claims disease modification in diabetes
But investors aren’t buying it.
June 26, 2023
The menin blocker BMF-219 could be a disease-modifying treatment for diabetes, Biomea Fusion claimed today after results suggested that diabetic patients’ blood sugar remained low even after they stopped taking the agent.
The data are a new cut from the phase 2 Covalent-111 trial of BMF-219, results from which in March had caused the company’s value to double. This time, however, investors are more sceptical, perhaps because disease modification is a brave claim to make in this disease. After climbing in the premarket Biomea stock opened down 16% today.
The data from Covalent-111 so far come from three cohorts. Cohort 1, consisting of 16 healthy volunteers, made up the phase 1 part of the trial. Cohorts 2 and 3 each consisted of 12 patients who had been diagnosed with type 2 diabetes at least 15 years earlier, and whose condition was poorly controlled despite treatment with up to three antidiabetic medications. The patients had BMIs of 25-40kg/m2, making them overweight or obese.
Cohort 2 received 100mg BMF-219 or placebo daily for four weeks, taken with food; cohort 3 the same but without food. At the four-week point impressive cuts to blood sugar were seen in these groups, though placebo response was also high.
The new data cut, presented as a late-breaker at the annual meeting of the American Diabetes Association on Friday, is from 12 weeks, with the patients having received no further BMF-219 treatment since the four-week point. Blood sugar control was maintained in most patients, with the number in the normal range actually increasing. Biomea attributed this to BMF-219’s theoretical ability to regenerate healthy insulin-producing cells.
Biomarker data too were encouraging, with the company claiming that this was the first time an investigational agent for the treatment of diabetes had caused an increase in levels of C-peptide that was maintained after treatment stopped.
Asked if anything other than beta cell proliferation could explain the findings, Dr Juan Pablo Frias, a scientific advisor to Biomea, said:
“In that short a period of time, I would say no, it would be extremely unusual. There's nothing else really that would be a feasible explanation for the improvement in glucose.”
There was a toxicity signal in another cohort that led to the company rethinking dosing as the trial continues. Patients given BMF-219 200mg along with food had more mild to moderate nausea compared with the group given 200mg without food. The former cohort will be moved to 100mg twice daily.
Otherwise safety was good, with two healthy volunteers given BMF-219 and one patient given placebo having mild treatment-emergent adverse events.
Disease modification in diabetes is a huge claim to rest on such a tiny, short study, and Biomea will have to back this up in a major way with much more data. The next steps are to complete the dose escalation, and Biomea will explore longer treatment duration – up to 12 weeks – in two more cohorts. It will also study the project in type 1 diabetes, where the likes of Vertex and Sernova are shooting for a functional cure. Updates will be watched with interest, but for now it seems not everyone is a true believer.
