MENIN'S ROLE IN DIABETES


Associated tags: Insulin, Diabetes, Patient, Syndrome, Hyperglycemia, Regeneration, Type 2 diabetes, Pancreas, Natural history, Cancer, Pharmaceutical industry, DSM-IV codes, Safety, Phase, Food, Osteopathic medicine in Canada, Week, C-peptide

Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

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Monday, April 1, 2024
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REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function

Retrieved on: 
Wednesday, March 6, 2024
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REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024. This clinical data from all dosing cohorts initiated to date as of February 12, 2024 from the Escalation Phase of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD. Biomea will showcase the following three e-poster presentations:

Key Points: 
  • Please find a link here to our website where the poster presentations and discussion will be available.
  • A higher proportion of patients treated with 200mg QD achieved a clinically significant reduction in HbA1c compared to 100mg QD dosing.
  • A durable glycemic response (≥1.0% HbA1C reduction) was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively.
  • A PK study further assessing the optimal use of BMF-219 to ensure minimal variability of exposure is currently under way.

Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts

Retrieved on: 
Saturday, December 9, 2023
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At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%.

Key Points: 
  • At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%.
  • As presented at the conference, we have shown for the first time the long-term follow-up data of our 100 mg patient cohorts.
  • By increasing the dose from 100 mg to 200 mg, we are excited about nearly doubling the percentage of patients treated with BMF-219 having a robust HbA1c reduction of 1% or more, 22 weeks after the last dose.
  • Phase II consists of multiple ascending dose (MAD) cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.

Biomea Fusion Presents Long-Term Follow-Up Data Showing Improved Glycemic Control after 22 Weeks Off Treatment in Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes in a Poster Presentation at the World Congress Insulin Resist

Retrieved on: 
Friday, December 8, 2023
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REDWOOD CITY, Calif., Dec. 08, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the poster presentation of long-term 26 weeks follow-up data from the first two cohorts of adults with type 2 diabetes (T2D) enrolled in the ongoing Phase II clinical study (COVALENT-111) and data from preclinical ex-vivo human islet experiments of BMF-219, the company’s investigational oral covalent menin inhibitor.

Key Points: 
  • “Our goal with BMF-219 is to create a short-term treatment regimen for patients with diabetes that results in long term glycemic control.
  • These early clinical results of improved glycemic control over time while patients are off treatment have been very impressive.
  • Phase II consists of multiple ascending dose (MAD) cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance, Diabetes & Cardiovascular Dis

Retrieved on: 
Thursday, December 7, 2023
Phase, C-peptide, Insulin resistance, Poster session, Insulin, Diabetes, Disease, QD, Menin, Glycated hemoglobin, Week, DSM-IV codes, CCNA2, Cancer, Food, PBK, Poster, A1C, Patient, Safety, Gene expression, Pharmaceutical industry

REDWOOD CITY, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the full abstract, titled “BMF-219: A novel therapeutic agent to reestablish functional beta cells and provide long-term glycemic control”, will be presented during the Abstract Oral Presentation Session as well as the Poster Session of the 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place in Los Angeles, California on December 7-9, 2023.

Key Points: 
  • BMF-219 is the first investigational agent to show durable glycemic control during off-treatment period after four weeks of dosing.
  • These data also further support the potential for BMF-219 as a disease modifying agent in type 2 diabetes.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion Announces Acceptance of Three Abstracts for its Novel Menin Inhibitor Highlighting Durable Glycemic Control in Diabetes Patients at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in 2024

Retrieved on: 
Monday, November 27, 2023
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These abstracts further validate the mechanism of action of covalently inhibiting menin in people with type 2 diabetes to potentially provide long-term improvement in glycemic control through beta cell regeneration.

Key Points: 
  • These abstracts further validate the mechanism of action of covalently inhibiting menin in people with type 2 diabetes to potentially provide long-term improvement in glycemic control through beta cell regeneration.
  • Biomea will disclose additional information about the presentations in accordance with the ATTD abstract embargo policies.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion Abstract “BMF-219: A Novel Therapeutic Agent to Reestablish Functional Beta Cells and Provide Long-term Glycemic Control" Selected as One of Six Oral Presentations at 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease

Retrieved on: 
Thursday, November 16, 2023
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The abstract “BMF-219: A Novel Therapeutic Agent to Reestablish Functional Beta Cells and Provide Long-term Glycemic Control" was selected as one of six oral presentations by the WCIRDC Abstract Committee.

Key Points: 
  • The abstract “BMF-219: A Novel Therapeutic Agent to Reestablish Functional Beta Cells and Provide Long-term Glycemic Control" was selected as one of six oral presentations by the WCIRDC Abstract Committee.
  • In the completed Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts to ensure safety at the prospective dosing levels for people with type 2 diabetes.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion to Present New Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

Retrieved on: 
Wednesday, November 8, 2023
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COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study.

Key Points: 
  • COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study.
  • In the completed Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts to ensure safety at the prospective dosing levels for type 2 diabetic patients.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 D

Retrieved on: 
Saturday, June 24, 2023
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These landmark findings support the potential disease-modifying impact of BMF-219,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board.

Key Points: 
  • These landmark findings support the potential disease-modifying impact of BMF-219,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board.
  • These historic data support our goal for BMF-219 to become the first disease-modifying treatment for patients with diabetes.
  • Phase II consists of multiple ascending dose (MAD) cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes at ADA 2023

Retrieved on: 
Tuesday, June 20, 2023
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Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.

Key Points: 
  • Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.
  • In March 2023, Biomea announced initial topline clinical data for the first two cohorts of patients with type 2 diabetes enrolled in the Phase II portion of the trial.
  • A link to the press release can be found here and a link to webcast can be found here .