Icovamenib for Healthy Volunteers

Overseen By Biomea Fusion Inc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biomea Fusion Inc.

Must not be taking: QT prolonging drugs, Weight loss drugs

Disqualifiers: Hypertension, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Single residency period

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs a new treatment called icovamenib under different food conditions. The study tests icovamenib with a low-fat breakfast, a high-fat breakfast, or on an empty stomach. Healthy individuals not on medication and with a BMI between 18 and 27 might be suitable for this trial. Participants will help researchers understand how food affects icovamenib's effectiveness and safety. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or over-the-counter drugs or herbal remedies (except for hormonal replacement therapy, hormonal contraception, and up to 4 grams per day of acetaminophen) at least 14 days before starting the study medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that icovamenib has been well-tolerated in previous studies. One study found icovamenib to be safe over a year-long period, with participants experiencing no serious side effects. Another study confirmed these results, indicating that icovamenib was safe and well-tolerated.

There is less direct information about icovamenib HPMC. However, since icovamenib itself has demonstrated good safety, it suggests that icovamenib HPMC might also be safe. This trial is in its early phase, marking the first step in understanding how the body reacts to these treatments. Researchers are studying both forms of the treatment to ensure their safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about icovamenib and its HPMC variant because they offer a potentially new way to manage conditions that require targeted therapies, especially given the flexibility in administration relative to meal timing and composition. Unlike existing standard treatments that may not account for these variables, icovamenib is being explored in various regimens, including fasted states and different meal types, which could optimize its absorption and effectiveness. The HPMC version, in particular, might provide a unique formulation that enhances delivery and efficacy, potentially offering more consistent therapeutic outcomes. This trial aims to uncover whether these variations make a significant difference in how the body processes the drug, which could lead to more personalized treatment approaches.

What evidence suggests that this trial's treatments could be effective?

This trial will study different regimens of icovamenib in healthy volunteers. Research has shown that icovamenib may improve conditions like severe insulin-deficient diabetes. In earlier studies, patients experienced a 1.2% drop in HbA1c levels, which indicate blood sugar, over a year. This improvement persisted even nine months after stopping the treatment. Additionally, icovamenib has helped control blood sugar and support weight loss when combined with other treatments. These findings suggest that icovamenib could be an effective treatment option. ^{1 5 6 7 8}

Who Is on the Research Team?

Biomea Fusion Inc.

Principal Investigator

Biomea Fusion Inc.

Are You a Good Fit for This Trial?

Healthy volunteers who understand the study, will follow its rules, have a BMI of 18.0-27.0 kg/m2, normal blood sugar levels, and are not pregnant or breastfeeding can join. People with heart issues, abnormal lab results, liver problems, certain infections like HIV/HBV/HCV or a family history of specific tumors cannot participate.

Inclusion Criteria

Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures

Must be willing and able to comply with all study requirements

Body mass index (BMI) of 18.0 to 27.0 kg/m2 as measured at screening

Exclusion Criteria

Mean QTcF interval greater than 440 msec on triplicate ECGs

Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator

AST, ALT or bilirubin > ULN at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of icovamenib capsule in various fed and fasted states to assess food effect and PK profile

Single residency period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PK profile and safety assessments

2 weeks

Every other day monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Icovamenib
• Icovamenib HPMC

Trial Overview The trial is testing how food affects the body's response to two forms of icovamenib (a drug in capsule form), using an open-label design where everyone knows what treatment they're getting. Participants will try both versions at different times to compare effects.

How Is the Trial Designed?

Group I: Regimen I Experimental Treatment 1 Intervention

I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)

Group II: Regimen H Experimental Treatment 1 Intervention

H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast)

Group III: Regimen G Experimental Treatment 1 Intervention

G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast)

Group IV: Regimen F Experimental Treatment 1 Intervention

F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)

Group V: Regimen E Experimental Treatment 1 Intervention

E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast)

Group VI: Regimen D Experimental Treatment 1 Intervention

D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)

Group VII: Regimen C Experimental Treatment 1 Intervention

C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)

Group VIII: Regimen B Experimental Treatment 1 Intervention

B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast)

Group IX: Regimen A Experimental Treatment 1 Intervention

A - icovamenib capsule 100mg in fasted state

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+

Citations

1. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-announces-positive-52-week-results-phase-ii

Biomea Fusion Announces Positive 52-Week Results from ... Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07254286?aggFilters=status%3A%2CfunderType%3Aindustry

NCT07254286 | Food Effect Study in Healthy Volunteers This study is designed to evaluate the effect of meal time and fat content of food on the PK and safety of the icovamenib capsule and the icovamenib ...

3. globenewswire.com globenewswire.com/news-release/2025/10/06/3162080/0/en/Biomea-Fusion-Announces-Positive-52-Week-Results-from-Phase-II-COVALENT-111-Study-in-Type-2-Diabetes-Demonstrating-Non-Chronic-Treatment-with-Icovamenib-Benefits-Two-Distinct-Patie.html

Biomea Fusion Announces Positive 52-Week Results from ... Among these severe insulin-deficient patients, icovamenib achieved a durable HbA1c reduction of 1.2% (p=0.01) sustained through Week 52. The ...

4. firstwordpharma.com firstwordpharma.com/story/5975450

Biomea Fusion Presents New Preclinical and Clinical Data ... The studies presented at ADA demonstrate that icovamenib enhanced glycemic control and drove additional weight loss when used in combination with GLP-1 ...

5. finance.yahoo.com finance.yahoo.com/news/biomea-fusion-presents-data-demonstrating-110000875.html

Biomea Fusion Presents Data Demonstrating Enhanced ... In a rodent model of T2D, icovamenib in combination with low-dose semaglutide promoted enhanced glycemic control and body weight reduction ...

6. medchemexpress.com medchemexpress.com/menin-mll-inhibitor-21.html?srsltid=AfmBOorftocExL9GMIvUutiucTdLVljeMVpWscdVtCXwgtnvK_x7Xa4b

Icovamenib (BMF-219) | Menin-MLL Inhibitor Icovamenib (BMF-219) is a selective, orally active, irreversible Menin inhibitor. Icovamenib forms a stable and irreversible covalent bond with Menin.

7. sec.gov sec.gov/Archives/edgar/data/1840439/000119312524283008/d827448dex991.htm

EX-99.1 Overall, icovamenib was well tolerated and demonstrated a favorable safety profile in the COVALENT-111 study. The company used clinical ...

8. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-reports-new-preclinical-data-icovamenib

Biomea Fusion Reports New Preclinical Data on Icovamenib ... Validated Safety. Icovamenib in combination with semaglutide was well tolerated across multiple time points. “We believe these preclinical ...