MYK-224 / BMS - LARVOL DELTA

A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Hepatology

A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Novel β-MYH7 mutations Causing HCM among Indians (AHA 2025) - "Additionally, several rare compound variations in the β-MYH7 gene were observed in 4 HCM patients, specifically: HCM1, (G354G, M362L & G389K); HCM2, (splice site (SS8) & F244F); HCM3, (E525K & D896N); and HCM4, (A423T, V431M & N602K-fs)... We identified Novel Mutations in the β-MYH7 Gene that lead to HCM among Indians. We provided valuable insights about causative mutations and their impact on the β-MYH7 protein structure, which may facilitate the development of therapeutic strategies for personalised medicine."

Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy • MYH7

Cardiac Myosin Inhibitors in the Treatment of Hypertrophic Cardiomyopathy: Clinical Trials and Future Challenges. (PubMed, Biomolecules) - "Keywords included "cardiac myosin inhibitor", mavacamten", "aficamten", "MYK-224", and "hypertrophic cardiomyopathy." Inclusion criteria encompassed clinical trials and comprehensive reviews specifically addressing CMIs in cardiac applications. While mavacamten has established efficacy, next-generation agents like aficamten may offer improved safety and versatility. Further long-term studies are needed to clarify their role across broader patient populations."

Journal • Review • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertrophic Cardiomyopathy • Non-obstructive Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy • Pediatrics

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2026 ➔ Feb 2025 | Active, not recruiting ➔ Terminated; Business objectives have changed

Trial completion date • Trial termination • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

CV029-1018: Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion

AURORA-HFpEF: Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=198 | Recruiting | Sponsor: Bristol-Myers Squibb | N=48 ➔ 198

Enrollment change • Cardiovascular • Congestive Heart Failure • Heart Failure

Investigation of Flurbiprofen Pharmacokinetics in Rats Following Dermal Administration of Optimized Cyclodextrin-Based Nanogel. (PubMed, Eur J Pharm Sci) - "The optimized nanogel provided prolonged drug permeation and more sustained pharmacokinetic performance compared to FP-HPMC gel."

Journal • PK/PD data • Preclinical

AURORA-HFpEF: Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jan 2025 ➔ Jul 2026 | Trial primary completion date: Jan 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

CV029-1018: Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

CV029-1018: Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | N=36 ➔ 18

Enrollment change • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

Construction of dual sites on FeS2 surface for enhanced electrocatalytic reduction of nitrite to ammonia. (PubMed, J Colloid Interface Sci) - "Direct experimental evidence was provided afterward: an NH3 yield rate of 424.5 μmol/hcm-2 with a 92.4 % Faradaic efficiency was achieved. Our findings not only suggest a promising NO2ER catalyst through theoretical computations to guide experiments but also provide a comprehensive understanding of the structure-properties relationship."

Journal

Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Metformin attenuates high-carbohydrate diet-induced redox imbalance, inflammation, and mitochondrial dysfunction in Megalobrama amblycephala. (PubMed, Fish Physiol Biochem) - "Compared with the HC group, metformin treatment (especially the HCM2 group) significantly elevated tissue glycogen contents, muscle SOD activity, plasma and liver antioxidant enzymes activities, the transcriptions of tgfβ and il10, the sodium/potassium ATPase activity, the contents of mitochondrial protein and AMP, the level of p-AMP activated protein kinase (AMPK), and the p-AMPK/t-AMPK ratio, but lowered the HSI, tissue lipid contents, plasma levels of glucose, AGES and glycated serum protein, plasma, and liver MDA contents, the transcriptions of il1β, NADH dehydrogenase subunit 1 and ATP 6, the contents of ATP and cytochrome c, the ATP/AMP ratio, and the activities of complexes I and IV. In conclusion, metformin could attenuate the HC diet-induced redox imbalance, inflammation, and mitochondrial dysfunction in blunt snout bream."

Journal • Gastrointestinal Cancer • Inflammation • Metabolic Disorders • CAT • IL10 • IL1B • TGFB1

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

Investigation of the safety of GH treatment for Noonan syndrome -single center experience. (ENDO 2024) - "The treatment was continued in consultation with a cardiologist and completed at the age of 17 y and 4 m. Another patient was diagnosed as HCM 2 years and 3 months after the start of treatment...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • Cardiomyopathy • Cardiovascular • Genetic Disorders • Heart Failure • Hematological Disorders • Hypertrophic Cardiomyopathy • Oncology • Solid Tumor

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Bristol-Myers Squibb | Phase classification: P2a ➔ P2

Phase classification • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

AURORA-HFpEF: Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

AURORA-HFpEF: Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2a | N=48 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2a trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P2a | N=36 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial primary completion date: Jul 2026 ➔ Apr 2024

Trial primary completion date • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy