A Phase 2 clinical trial for adults
with stage 3 Type 1 Diabetes
About COVALENT-112
This multi-arm trial includes an initial Part 1 – open label study followed by a Part 2 – randomized, double-blind, placebo-controlled Phase 2 study in adults with stage 3 Type 1 Diabetes. Both Part 1 and Part 2 accept participants with time to diagnosis less than 3 years and between 3 to 15 years.
What is the NCT number for COVALENT-112?
The National Clinical Trial reference number is: NCT06152042.
When you talk with your doctor or clinical trial team member, please have the national trial reference number available.
What does it mean to be randomized, double-blind, placebo-controlled study?
It means that 1 out of 3 patients will receive the BMF-219 at 100mg, 1 out of 3 patients will receive BMF-219 at 200mg, and 1 out of 3 patients will receive placebo. This allocation will be based on chance and neither the treating physician nor the patient will know their assignment during the treatment period.
What does it mean to be open label study?
It means all patients will receive the BMF-219, the study drug and that the dose level will be pre-allocated. There will be no placebo and the allocation will not be based on chance.
Will it cost me anything?
Study medication and study-related care will be provided at no cost.
Phase II Patient eligibility
Age:
18 – 70 years
18 – 70 years
Sex:
All
Conditions:
Stage 3
Type 1 Diabetes
Stage 3
Type 1 Diabetes
Patients would qualify for the trial if they meet the following criteria:
- Be 18 to 70 years of age
- All sexes included
- Diagnosed with Stage 3 Type 1 Diabetes
And also:
- HbA1c ≥ 6.5% and ≤ 10% at screening
- BMI ≤ 40 kg/m2
The science behind COVALENT-112
Loss of functional beta cell mass is a core component of the natural history in type 1 diabetes (mediated by autoimmune dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta-cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells.
BMF-219 was specifically designed to inhibit menin and has shown the potential to restore functional beta cell mass in preclinical studies. Biomea is exploring the potential for BMF-219-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of type 1 diabetes.
What is BMF-219?
BMF-219 is an investigational, orally bioavailable small molecule, which covalently binds to the scaffold protein menin, an important transcriptional regulator known to play a direct role in regulating beta cell growth.
Trial locations
Contact us
Phone:
1 (844) 245-0490
1 (844) 245-0490
If you think this clinical trial might be a good fit and you’re interested in taking part, fill out the form below or call our hotline to contact our clinical trials team.