Biosergen's BSG005 Shows Promise Against Resistant Fungal Infections in Clinical Trial
• Biosergen has successfully completed the second patient cohort in its BSG005 proof-of-concept trial, with eight of ten patients showing clinical improvement against life-threatening fungal infections.
• BSG005, a next-generation polyene antifungal, demonstrated fungicidal activity against resistant strains, offering hope for patients who have failed standard treatments.
• The company plans to advance to a third cohort in Q4 2025 and is preparing for global Phase II/III trials, with regulatory discussions ongoing with India's CDSCO and the U.S. FDA.
NPPA Sets Retail Prices for 84 Drugs Including Empagliflozin Combinations Following Patent Expiry
• India's National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 84 new drug formulations, including 36 combinations containing the recently off-patent diabetes medication empagliflozin.
• The price regulations follow the March 11, 2025 expiry of Boehringer Ingelheim's empagliflozin patent, opening the market to multiple pharmaceutical companies including Mankind Pharma, Lupin, and Alkem Laboratories.
• Beyond diabetes medications, the NPPA's pricing decisions also cover anti-hypertensive combinations containing telmisartan and metoprolol, as well as anti-inflammatory formulations with paracetamol and mefenamic acid.
Glenmark Expands Diabetes Care Portfolio with Launch of Empagliflozin and Fixed-Dose Combinations in India
• Glenmark Pharmaceuticals has launched Empagliflozin (Glempa) and its fixed-dose combinations in India, offering new treatment options for type 2 diabetes patients with cardiovascular risks.
• Clinical trials demonstrated Empagliflozin provides significant benefits including 14% reduction in major cardiovascular events, improved glycemic control, and weight loss of 2-3.8kg in combination therapies.
• The Glempa product range includes three formulations: standalone Empagliflozin, Empagliflozin+Linagliptin (Glempa-L), and Empagliflozin+Metformin (Glempa-M), addressing diverse patient needs with affordable treatment options.
Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost
• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility.
• Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet.
• The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.
CDSCO Panel Approves Phase III Trial of Semaglutide Injection with Enhanced Retinal Monitoring
• Sun Pharma and Alkem Laboratories receive CDSCO approval to proceed with Phase III clinical trials for their respective semaglutide injection solutions.
• The CDSCO's Subject Expert Committee (SEC) mandates retinal examinations (fundoscopies) at each visit during the Phase III trials to monitor potential retinal complications.
• Semaglutide, a GLP-1 receptor agonist, is used to manage type 2 diabetes by improving insulin secretion and reducing glucose production, also reducing cardiovascular risks.
• The trials aim to evaluate the bioequivalence and efficacy of semaglutide injections in controlling blood sugar levels and reducing cardiovascular risks in patients with type 2 diabetes.
Sonnet BioTherapeutics Advances SON-1010 Combination Trial for Sarcoma Treatment
• Sonnet BioTherapeutics expands Phase 1 SB101 trial to evaluate SON-1010 in combination with trabectedin for patients with unresectable, metastatic liposarcoma or leiomyosarcoma.
• The trial will enroll up to 18 patients, with a primary focus on safety, tolerability, and pharmacokinetics, utilizing the established maximum tolerated dose of 1200 ng/kg.
• SON-1010, a proprietary IL-12 formulation, aims to enhance immune response in the tumor microenvironment by converting 'cold' tumors to 'hot,' potentially improving treatment outcomes in earlier-stage patients.
Biosergen Completes Enrollment of First Cohort in BSG005 Proof-of-Concept Trial for Invasive Fungal Infections
• Biosergen has completed enrollment of the first cohort in its BSG005 proof-of-concept trial, evaluating the drug as a rescue therapy for severe fungal infections.
• The trial includes patients who have failed standard-of-care antifungal treatments or have kidney impairment, addressing a significant unmet medical need.
• Early results show promising signs, with one patient with mucormycosis avoiding lung surgery after BSG005 treatment, demonstrating potential life-saving impact.
• Biosergen plans to enroll up to 15 patients by January 2025, with Alkem Laboratories financing subsequent Phase 2 and 3 trials in India upon successful completion.
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