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Clinical Trial News

AIIMS-Led Study Demonstrates Equal Efficacy of Three Two-Drug Hypertension Combinations in South Asian Patients

  • The TOPSPIN trial, led by AIIMS Delhi, found that three commonly used two-drug combination pills for hypertension showed equal effectiveness in reducing blood pressure among South Asian patients, with all combinations achieving approximately 14/8 mmHg reduction in 24-hour ambulatory measurements.
  • Nearly 70% of the 1,981 participants achieved blood pressure control below 140/90 mmHg after 6 months of treatment, representing a significant improvement over current national control rates in India.
  • All three combinations (amlodipine-perindopril, amlodipine-indapamide, and perindopril-indapamide) demonstrated similar safety profiles with less than 3% of participants discontinuing therapy due to side effects.
  • The study provides the first robust evidence for optimal dual combination therapy in South Asian populations, who represent a quarter of the world's population and face an enormous hypertension burden with poor control rates.

FDA Approves Doptelet for Pediatric Immune Thrombocytopenia with New Sprinkle Formulation

Drug Approval
  • The FDA has approved Doptelet (avatrombopag) for treating thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia who have had insufficient response to prior therapy.
  • The approval includes a new pediatric-friendly sprinkle formulation for children ages one to less than six years, offering flexible oral administration with no food restrictions.
  • In the pivotal AVA-PED-301 phase 3 study, 27.8% of patients receiving Doptelet achieved durable platelet response compared to 0% in the placebo group, with 81.5% achieving alternative platelet response endpoints.
  • The oral thrombopoietin receptor agonist was generally well-tolerated, with the most common side effects being viral infections, nasopharyngitis, cough, fever, and sore throat.

Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

NCT04516967Active, Not RecruitingPhase 3
Sobi, Inc.
Posted 3/5/2021

Kintor Pharma's KX-826 Hair Loss Treatment Achieves Primary Endpoint in Phase II Trial

  • Kintor Pharma's KX-826 tincture 1.0% achieved its primary endpoint in a Phase II clinical trial for male androgenetic alopecia treatment.
  • Both 0.5% and 1.0% twice-daily dosing groups showed statistically significant hair growth improvements compared to placebo after 24 weeks.
  • The treatment demonstrated satisfactory safety profile with no drug-related sexual dysfunction adverse events reported.
  • An independent Data Monitoring Committee recommended proceeding to Phase III without modifications to study design or sample size.

Plant Virus Nanoparticles Show Promise as Novel Cancer Immunotherapy in Preclinical Studies

  • Researchers at UC San Diego have demonstrated that cowpea mosaic virus (CPMV) nanoparticles derived from black-eyed pea plants can effectively stimulate immune responses against cancer in preclinical models.
  • The treatment showed remarkable success in improving survival rates and suppressing metastatic tumor growth across colon, ovarian, melanoma, and breast cancer models when administered systemically.
  • CPMV uniquely activates type I, II, and III interferons and toll-like receptor 7 (TLR7), creating both immediate and long-lasting anti-tumor immune responses.
  • The plant virus-based therapy offers a cost-effective alternative to traditional immunotherapies, as it can be cultivated using molecular farming with basic agricultural resources.

European Regulators Recommend Expanding Novo Nordisk's Alhemo for Hemophilia A and B Without Inhibitors

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending label expansion of Alhemo (concizumab) to treat severe hemophilia A and moderate/severe hemophilia B without inhibitors.
  • Phase 3 explorer8 trial results showed Alhemo prophylaxis reduced bleeding episodes by 86% in hemophilia A patients and 79% in hemophilia B patients compared to no prophylaxis treatment.
  • The label expansion would make Alhemo available to approximately 12,000 EU patients with hemophilia A and B without inhibitors, representing 79.2% of the market segment.
  • Patient-reported outcomes demonstrated 70.9% of participants preferred Alhemo over their previous hemophilia treatment, with improvements in quality of life and reduced treatment burden.

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

NCT04083781Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 10/21/2019

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

NCT04082429Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 11/13/2019

MilliporeSigma and Washington University Strengthen 90-Year Partnership to Accelerate Life Sciences Innovation

  • MilliporeSigma and Washington University in St. Louis have signed a memorandum of understanding to expand their nearly century-long collaboration, focusing on joint research initiatives and technology development.
  • The partnership aims to build a robust research and development talent pipeline in St. Louis, where MilliporeSigma employs approximately 2,300 people across production and R&D facilities.
  • The collaboration will provide university researchers with access to MilliporeSigma's portfolio of over 300,000 products and technical expertise to accelerate the transition from laboratory discoveries to clinical applications.
  • MilliporeSigma has invested more than $250 million in its St. Louis operations over the past five years and previously contributed nearly $14 million worth of laboratory equipment to WashU scientists.

Adocia's Ultra-Rapid Insulin BioChaperone Lispro Meets Primary Endpoint in Phase 3 Trial for Type 2 Diabetes

  • BioChaperone Lispro (THDB0206) demonstrated non-inferior HbA1c reduction compared to Humalog in a Phase 3 trial of 1,040 Chinese adults with Type 2 diabetes.
  • The ultra-rapid insulin formulation showed statistically significant reduction in post-meal blood glucose rise and improved daily glucose control versus standard care.
  • The trial results support Adocia's partnership with Tonghua Dongbao and advance the innovative insulin toward potential regulatory approval in China.

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes

NCT05834868RecruitingPhase 3
Tonghua Dongbao Pharmaceutical Co.,Ltd
Posted 5/6/2022

Fermented Stevia Extract Shows Selective Cytotoxicity Against Pancreatic Cancer Cells in Laboratory Study

  • Researchers at Hiroshima University discovered that fermented stevia extract demonstrates significantly greater cytotoxicity against pancreatic cancer cells compared to non-fermented stevia extract.
  • The fermentation process with Lactobacillus plantarum SN13T creates chlorogenic acid methyl ester (CAME), which selectively kills cancer cells while sparing healthy kidney cells.
  • Laboratory tests showed fermented stevia extract blocks cancer cells at specific life cycle phases and triggers apoptosis, offering potential for targeted cancer therapy development.
  • The findings represent early-stage research requiring animal and human studies before clinical applications can be considered.

EU Regulatory Approval Advances Pfizer-BioNTech LP.8.1-Adapted COVID-19 Vaccine for 2025-2026 Season

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Pfizer and BioNTech's LP.8.1-adapted COMIRNATY vaccine targeting XFG and NB.1.8.1 variants.
  • The updated vaccine demonstrates improved immune responses against emerging SARS-CoV-2 sublineages and maintains a safety profile consistent with prior formulations.
  • European Commission authorization is expected to enable vaccine deployment as early as fall 2025 for the 2025-2026 season, with manufacturing already underway at risk.
  • The global mRNA vaccines and therapeutics market is projected to grow at 13.3% CAGR, expanding from $53.14 billion in 2025 to $144.31 billion by 2033.

Everest Medicines Raises HK$1.57 Billion to Accelerate AI+mRNA Platform and Pipeline Development

CAR-TOncology
  • Everest Medicines completed a significantly oversubscribed share placement raising approximately HK$1.57 billion to fund global R&D and commercialization efforts.
  • The company will allocate 50% of proceeds to advance its AI+mRNA platform, including EVM14 and EVM16 cancer vaccines that have achieved regulatory milestones.
  • EVM14 became Everest's first mRNA therapeutic vaccine to receive dual IND acceptance from both China's NMPA and the U.S. FDA.
  • The funding will also support commercialization of existing products including NEFECON for IgA nephropathy and the anticipated approval of VELSIPITY for ulcerative colitis.

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