What is the mechanism of action of this treatment?

Common treatments for Type 1 Diabetes (T1D) that focus on beta cell preservation and immune modulation aim to protect and restore the function of insulin-producing beta cells in the pancreas. Beta cell preservation strategies, such as the use of imatinib, work by reducing inflammation and oxidative stress, thereby improving beta cell function and insulin secretion. Immune modulation treatments, like abatacept, target the autoimmune response that destroys beta cells by inhibiting T cell activation. These approaches are crucial for T1D patients as they address the root cause of the disease—autoimmune destruction of beta cells—potentially leading to better glycemic control and reduced dependence on exogenous insulin.

What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes that focus on beta cell preservation or immune modulation include teplizumab and otelixizumab. Teplizumab has been shown to slow the loss of beta-cell function and improve glycemic control, but it can cause mild and limited-duration adverse events. Otelixizumab has demonstrated better maintenance of residual beta-cell function and reduced insulin dose requirements, but specific side effects were not detailed. Broadly, immune modulation therapies can lead to risks such as infections and other immune-related adverse effects.

What prior FDA approvals exist?

Teplizumab is an immune-modulating therapy that has shown promise in slowing the rate of beta-cell loss in patients with new-onset Type 1 Diabetes, as evidenced by Phase I/II trials. Abatacept, another immune-modulating drug, has demonstrated the ability to delay the loss of beta-cell function in newly diagnosed patients by blocking T cell activation. Both therapies aim to preserve beta-cell function, aligning with the goals of treatments like BMF-219, which focuses on beta-cell preservation and regeneration.

What other types of research exist?

Promising novel alternatives to BMF-219 for Type 1 Diabetes patients include abatacept, which modulates T cell costimulation to slow beta-cell destruction, and caspase inhibitors like IDN-6556, which improve islet engraftment and survival post-transplantation. Both therapies have shown potential in clinical trials and could be considered for treatment in 2024.

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BMF-219 for Type 1 Diabetes (BF-MNN-112 Trial)

Phase 2

Waitlist Available

Research Sponsored by Biomea Fusion Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females, age ≥18 and ≤60 years.

Treated with insulin only (no other diabetes medications) for at least 2 months prior to screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Summary

This trial tests BMF-219, an oral medication that blocks a protein called menin, in people with Type 1 Diabetes. The goal is to see if it can help their insulin-producing cells work better and improve how their bodies handle sugar and fats.

Who is the study for?

Adults aged 18-60 with Type 1 Diabetes diagnosed within the last 3 years are eligible for this trial. They must be using only insulin to manage their diabetes, have an HbA1c level between 6.5% and 10%, a BMI of up to 40 kg/m2, and certain levels of C-peptide.

What is being tested?

The trial is testing BMF-219 in people with Type 1 Diabetes to see how effective it is. Participants will receive BMF-219 under controlled conditions to monitor its impact on their blood sugar control and overall health.

What are the potential side effects?

Specific side effects of BMF-219 aren't listed here, but common drug-related side effects may include nausea, low blood sugar episodes (hypoglycemia), headaches, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have been using insulin exclusively for my diabetes for at least 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the effect on endogenous insulin secretion

Secondary study objectives

Incidence of adverse events

Rate of symptomatic hypoglycemic episodes

To assess hypoglycemia events

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2Experimental Treatment1 Intervention

Part 2 Part 2 uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio: * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks

Group II: Part 1Experimental Treatment1 Intervention

Part 1 uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The Part 1 Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms: * Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks * Cohort 2: Participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L. * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks

Group III: Placebo ComparatorPlacebo Group1 Intervention

Part 2 Study Double Blind Arm C matching placebo for 12 weeks.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes (T1D) that focus on beta cell preservation and immune modulation aim to protect and restore the function of insulin-producing beta cells in the pancreas. Beta cell preservation strategies, such as the use of imatinib, work by reducing inflammation and oxidative stress, thereby improving beta cell function and insulin secretion. Immune modulation treatments, like abatacept, target the autoimmune response that destroys beta cells by inhibiting T cell activation. These approaches are crucial for T1D patients as they address the root cause of the disease—autoimmune destruction of beta cells—potentially leading to better glycemic control and reduced dependence on exogenous insulin.

Hypoxia-inducible factors and diabetes.Beta-Cell Mass in Obesity and Type 2 Diabetes, and Its Relation to Pancreas Fat: A Mini-Review.B lymphocytes protect islet β cells in diabetes prone NOD mice treated with imatinib.