▎WuXiEdited by Kant Content Team

Reducing RSV-related hospitalization rates by over 80%, FDA accepts Merck's long-acting antibody therapy for market application

MSD announced today that the U.S. FDA has accepted the company’s Biologics License Application (BLA) for clesrovimab (MK-1654), an investigational preventive long-acting monoclonal antibody, aimed at protecting infants from RSV disease during their first respiratory syncytial virus (RSV) season. The FDA is set to complete its review by June 10, 2025.Clesrovimab is an investigational extended half-life monoclonal antibody used as a passive immunization method to prevent RSV disease.

This application is based on the results of the pivotal Phase 2b/3 clinical trial CLEVER, a randomized, placebo-controlled trial evaluating the effects of a single dose of clesrovimab in healthy preterm and full-term infants; as well as interim results from the ongoing Phase 3 clinical trial SMART, which assesses the safety and efficacy of clesrovimab compared to palivizumab in high-risk infants and children. Data from these trials were presented at the IDWeek 2024 conference held in October 2024.Data show that clesrovimab reduced RSV-related hospitalization rates and RSV-related lower respiratory tract infection (LRI) hospitalization rates by 84% and over 90%, respectively, within five months.

Prevent Weight Rebound, Verge Genomics Nominates Potential "First-in-Class" Therapy

Verge Genomics, a clinical-stage biotechnology company leveraging artificial intelligence (AI) and human data to drive drug discovery and development, today announced the nomination of its second candidate drug, VRG201, aimed at long-term weight management and metabolic homeostasis.VRG201 is a potential “first-in-class” oral therapy designed to correct underlying metabolic dysfunction that leads to obesity, helping individuals maintain weight loss without significant lifestyle changes.

Obesity has become a global health crisis, affecting more than 650 million adults worldwide and significantly impacting cardiovascular health, diabetes, and liver disease. While glucagon-like peptide-1 (GLP-1) receptor agonists have revolutionized weight management by reducing calorie intake, their effects are often difficult to sustain. Up to 50% of patients discontinue GLP-1 medications within the first year of treatment, leading to subsequent weight regain.

VRG201 selectively inhibits CD38, a key enzyme that regulates cellular nicotinamide adenine dinucleotide (NAD+) levels and energy metabolism.By restoring NAD+ balance and inhibiting CD38 upregulation, VRG201 can improve metabolic function and prevent excess calories from being converted into fat. This mechanism gives VRG201 the potential to complement GLP-1 drugs and provide a new approach for treating metabolic diseases.

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