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Clinical Trial News

MindBio Therapeutics Advances MB22001 Microdosing for Depression with Phase 2 Trials

  • MindBio Therapeutics has completed a Phase 2a trial of MB22001 for major depressive disorder, showing a 60% reduction in depressive symptoms and a 53% remission rate.
  • The company has initiated a Phase 2b trial of MB22001, a proprietary form of LSD, involving take-home microdosing for patients with major depressive disorder.
  • MindBio is also exploring a dual listing on a senior exchange in the United States or Australia, following positive clinical trial results.
  • Prior trials of MB22001 showed statistically significant improvements in sleep quality, mood, and overall well-being, suggesting potential as a disruptive treatment for depression.

Newron's Evenamide Shows Breakthrough Results in Treatment-Resistant Schizophrenia Phase II/III Trials

  • Newron Pharmaceuticals' evenamide demonstrated clinically significant improvements in treatment-resistant schizophrenia patients, with 70% showing meaningful reductions in disease severity and 25% achieving remission in Phase II trials.
  • The company's Phase II/III study in 291 chronic schizophrenia patients met primary and secondary endpoints, showing statistically significant symptom improvements when added to second-generation antipsychotics.
  • Newron is preparing for a potentially pivotal Phase III trial in at least 400 treatment-resistant schizophrenia patients beginning in 2025, while actively exploring partnerships to fund development.
  • The drug demonstrated a favorable safety profile with only 25% of participants experiencing adverse events, positioning it as a potential breakthrough therapy for underserved patient populations.

Chime Biologics and Mabgeek Achieve PPQ Milestone for MG-K10, Advancing Atopic Dermatitis and Asthma Therapies

  • Chime Biologics and Mabgeek completed Process Performance Qualification (PPQ) for MG-K10, a humanized anti-IL-4Rα monoclonal antibody, crucial for regulatory compliance and manufacturing validation.
  • MG-K10 targets Th2-mediated inflammatory diseases like atopic dermatitis and asthma, with Phase III clinical trials underway, and is designed for once-monthly dosing.
  • The collaboration focuses on commercial manufacturing and CMC development to accelerate MG-K10's commercialization in American and European markets, emphasizing strong efficacy and patient adherence.
  • MG-K10 has shown potential as a best-in-class treatment, improving clinical signs and lung function in Phase II trials for atopic dermatitis and asthma, respectively.

University of Florida mRNA Vaccine Shows Rapid Immune Response Against Glioblastoma in First Human Trial

  • A personalized mRNA vaccine developed at the University of Florida triggered a strong immune response against glioblastoma within 48 hours in a first-ever human clinical trial of four patients.
  • The vaccine uses patients' own tumor cells to create personalized treatment and employs a novel lipid nanoparticle delivery system that clusters particles to enhance immune activation.
  • Results showed tumors shifted from "immune cold" to "hot" states rapidly, with patients living disease-free or surviving longer than expected, leading to expansion into a Phase 1 trial of 24 patients.
  • The breakthrough represents a potential new paradigm for treating the most aggressive brain cancer, which has a median survival of only 12-18 months with current standard care.

Jacobio Pharma's Glecirasib Shows Promise in KRAS G12C-Mutated NSCLC

  • Jacobio Pharma's glecirasib demonstrated a confirmed objective response rate (cORR) of 47.9% in second-line non-small cell lung cancer (NSCLC) patients.
  • The Phase II registrational study of glecirasib showed a median progression-free survival (mPFS) of 8.2 months and a median overall survival (mOS) of 13.6 months.
  • Glecirasib has a manageable safety profile, with only 5.0% of patients discontinuing treatment due to treatment-related adverse events (TRAEs).
  • Glecirasib received orphan drug designation for pancreatic cancer from the FDA and breakthrough therapy designation from China's CDE.

GSK Reports Strong Q1 2024 Driven by Pipeline Progress and Key Therapeutic Areas

  • GSK's Q1 2024 demonstrates robust performance, fueled by advancements in its pipeline and positive Phase III data across multiple therapeutic areas.
  • The company highlights strengthened growth prospects in infectious diseases, HIV, respiratory/immunology, and oncology, indicating a diversified approach.
  • GSK anticipates continued momentum throughout 2024, projecting meaningful growth in both sales and earnings based on recent R&D achievements.
  • The report emphasizes forward-looking statements are subject to uncertainties, including market conditions and regulatory changes, advising investor caution.

Eton Pharmaceuticals Submits NDA to FDA for ET-400 (Hydrocortisone Oral Solution)

  • Eton Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for ET-400, a patented hydrocortisone oral solution, aimed at treating adrenocortical insufficiency.
  • The FDA review is expected to take 10 months, potentially leading to approval and market launch in the first quarter of 2025, addressing a critical need for children.
  • ET-400 is protected by a U.S. patent expiring in 2043, with additional patent applications pending, highlighting its unique formulation and market exclusivity.
  • Eton anticipates that ET-400, along with Alkindi Sprinkle, could achieve combined peak sales exceeding $50 million annually, reflecting strong demand from patients and physicians.

FDA Updates LUPKYNIS® Label with Three-Year Data and Modified Kidney Function Monitoring Guidelines for Lupus Nephritis

  • The FDA has updated the label for LUPKYNIS® (voclosporin) to include three-year data from the AURORA 2 extension study, demonstrating sustained complete renal response in patients with lupus nephritis (LN).
  • The updated label provides new guidance for monitoring kidney function, recommending quarterly eGFR assessments after the first year of treatment, aligning with standard clinical care.
  • The safety profile of LUPKYNIS® remains consistent with previous findings from the AURORA clinical program, with no new safety concerns identified in the long-term data.
  • A post hoc analysis showed that 20.1% of patients on LUPKYNIS achieved sustained complete renal response compared to 11.8% on placebo, highlighting the drug's long-term efficacy.

FDA Implements Historic Regulation of Laboratory-Developed Tests with New Final Rule

  • The FDA has issued a final rule to regulate laboratory-developed tests (LDTs), marking a significant shift from its previous enforcement discretion approach to comprehensive oversight.
  • The new regulation introduces a 4-year phase-out period and will require LDTs to meet the same standards as other in vitro diagnostic devices, with exceptions for certain existing tests and unmet needs.
  • The rule aims to ensure test accuracy and patient safety, particularly for critical applications like cancer risk assessment and disease diagnosis, though it faces mixed reactions from industry stakeholders.

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