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Clinical Trial News

Metsera's Monthly Amylin Injection Achieves 8.4% Weight Loss in Phase I Trial

  • Metsera's ultra-long-acting amylin injection MET-233i demonstrated 8.4% placebo-adjusted weight loss at 36 weeks in Phase I trial with once-monthly dosing.
  • The drug showed a 19-day half-life supporting monthly administration and patients maintained weight loss for over four weeks after treatment.
  • MET-233i exhibited a clean safety profile with mild gastrointestinal side effects limited to the first week, suggesting rapid tolerance development.
  • The company plans to continue monotherapy studies and test combination therapy with its GLP-1 drug MET-097i, with results expected by year-end 2025.

Glenmark Pharmaceuticals Receives DCGI Approval to Launch BRUKINSA for Five B-Cell Malignancies in India

Drug ApprovalOncology
  • Glenmark Pharmaceuticals has received DCGI approval to launch zanubrutinib (BRUKINSA) in India, marking the first BTK inhibitor approved for treating five distinct B-cell malignancies.
  • BRUKINSA is approved for chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma.
  • The drug is already approved in more than 70 countries globally and is supported by clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA.
  • The launch represents a significant expansion of innovative oncology treatments for Indian patients through Glenmark's partnership with BeiGene (now BeOne Medicines).

Everest Medicines Reports Promising Phase 1b/2a Results for EVER001 BTK Inhibitor in Primary Membranous Nephropathy

  • Everest Medicines presented positive Phase 1b/2a trial results for EVER001, a next-generation covalent reversible BTK inhibitor, showing significant efficacy in treating primary membranous nephropathy at the 62nd European Renal Association Congress.
  • The trial demonstrated substantial reductions in anti-PLA2R autoantibodies (up to 93% at week 24) and proteinuria (78% reduction sustained through week 52 in low-dose cohort), with favorable safety profile and no serious adverse events associated with earlier BTK inhibitors.
  • EVER001 addresses a critical unmet medical need as no drugs are currently approved globally for primary membranous nephropathy, which affects approximately 2.2 million patients worldwide and represents the second most common cause of primary glomerulonephritis.

EMA Extends Shelf Life of Veterinary Cancer Drug MASIVET to 48 Months

Oncology
  • The European Medicines Agency has approved extending the shelf life of MASIVET, a veterinary cancer treatment, from 36 months to 48 months for the 50mg tablet formulation.
  • MASIVET is specifically indicated for treating non-resectable mast cell tumors in dogs with Grade 2 or 3 severity and confirmed c-kit tyrosine kinase receptor mutations.
  • The shelf-life extension provides greater inventory management flexibility for veterinarians and caregivers while reducing product expiration risks across all EU countries.
  • This regulatory approval ensures continued treatment availability and supports veterinarians in providing optimal care for canine cancer patients.

Advent International Invests $175 Million in Animal Health Generics Company Felix Pharmaceuticals

  • Advent International has signed a definitive agreement to invest $175 million for a significant minority stake in Felix Pharmaceuticals, a Dublin-based company developing generic medicines for companion animals.
  • Felix Pharmaceuticals operates in the nascent animal health generics market where generic players hold less than 10% market share, providing substantial long-term growth opportunities.
  • The company has achieved rapid growth since its 2015 founding, securing 14 US FDA-approved products and serving 200 clients globally through its specialized veterinary manufacturing facilities.
  • The global animal pharmaceutical market is projected to reach $96.56 billion by 2033, growing at a CAGR of 5.13% from 2025 to 2033, driven by increasing pet ownership and healthcare spending.

Philippines FDA Expands VAT-Free Medicine List to Include New Cancer, Diabetes, and Cardiovascular Treatments

Drug Approval
  • The Philippines FDA has expanded its VAT-exempt medicine list to include additional treatments for cancer, diabetes, hypertension, and other conditions under President Marcos's directive to reduce medicine costs.
  • New cancer medications include Tegafur combination capsules and established treatments like Bortezomib, Docetaxel, Lenvatinib, Lenalidomide, and Paclitaxel.
  • Diabetes treatments now include Metformin-Teneligliptin combinations and Saxagliptin-Dapagliflozin tablets, while cardiovascular medicines feature new combination therapies.
  • The expansion covers 10 additional medications across multiple therapeutic areas including mental health treatments with Lamotrigine formulations.

Otsuka Pharmaceutical Challenges Vera Therapeutics in Kidney Disease Race as GLP-1 Drugs Face Eye Safety Scrutiny

  • Otsuka Pharmaceutical is advancing efforts to challenge Vera Therapeutics in developing effective treatments for kidney diseases, with both companies focusing on innovative approaches to address unmet medical needs.
  • New data has emerged linking GLP-1 receptor agonists to potential eye-related complications, prompting increased scrutiny from regulatory bodies and healthcare professionals.
  • The safety concerns involve GLP-1 drugs widely prescribed for managing Type 2 diabetes and obesity, with reports suggesting a potential association with retinal issues.

Samsung Bioepis Partners with NIPRO to Commercialize Biosimilars in Japan, Including Ustekinumab Candidate

  • Samsung Bioepis has entered into a strategic partnership with NIPRO Corporation for the development and commercialization of multiple biosimilar candidates in Japan, including SB17, a ustekinumab biosimilar.
  • Under the agreement, Samsung Bioepis will handle development, manufacturing and supply while NIPRO will be responsible for commercialization activities in the Japanese market.
  • The partnership aims to expand treatment access and bring cost savings to Japan's healthcare system across multiple therapeutic areas including immunology, oncology, and endocrinology.

Chronic GVHD Treatment Evolution: Biomarker-Guided Therapy and Steroid-Free Approaches Show Promise

  • Steroid response rates in chronic graft-vs-host disease remain at approximately 50%, prompting research into combination therapies and earlier introduction of newer drugs to improve treatment outcomes.
  • Biomarker-guided therapy represents a revolutionary approach that could replace current generalized treatment algorithms with personalized care protocols for chronic GVHD patients.
  • Clinicians are increasingly using off-label combination therapies, such as combining Rexona and belimumab, to achieve steroid-sparing regimens and reduce long-term toxicity risks.
  • The development of steroid-free first-line treatments is a critical research priority to eliminate cardiovascular complications, osteoporosis, and diabetes associated with long-term steroid use.

Revolutionary Gene Therapy and BBB-Penetrating Treatments Transform Hunter Syndrome Treatment Landscape

Rare DiseaseDrug Approval
  • RGX-121, a one-time gene therapy using AAV vector technology, is expected to receive regulatory approval in the second half of 2025, potentially offering lifelong benefits from a single infusion for Hunter Syndrome patients.
  • Tividenofusp alfa and Verenafusp alfa represent breakthrough therapies designed to cross the blood-brain barrier, addressing both CNS and somatic symptoms that current treatments like Elaprase cannot reach.
  • The Hunter Syndrome treatment paradigm is shifting from weekly enzyme replacement therapy costing over $500,000 annually to potentially curative single-dose treatments targeting neurological decline.
  • IZCARGO, launched in Japan in 2021, currently stands as the only approved therapy addressing both somatic and CNS symptoms by crossing the blood-brain barrier, though availability remains limited to the Japanese market.

Safety and Efficacy of HMI-203 in ERT-Treated Adults With MPS II

NCT05238324WithdrawnPhase 1
Homology Medicines, Inc
Posted 9/8/2022

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