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Clinical Trial News

FDA Grants Fast Track Status to BBO-8520 for KRAS G12C-Mutated NSCLC

  • The FDA has granted fast track designation to BBO-8520, an oral agent under investigation for treating KRAS G12C-mutated metastatic non-small cell lung cancer.
  • This designation aims to expedite the development and review of BBO-8520, addressing an unmet need in previously treated NSCLC patients.
  • The decision was based on the drug's potential to improve outcomes in this specific genetic subgroup of lung cancer, where treatment options are limited.

BD Completes 50-Subject Clinical Trial for Libertas Wearable Injector System

  • BD has completed a 50-subject human clinical trial evaluating the performance of its BD Libertas Wearable Injector, a subcutaneous drug delivery system designed for biologics administration.
  • The study assessed the 5-mL device configuration's tissue effects, skin reactivity, and patient acceptance, with results expected to be announced in early 2020.
  • This trial represents the latest in a series of over 50 BD-conducted preclinical and clinical studies aimed at demonstrating the feasibility of 2-10 mL biologic injections into subcutaneous tissue.
  • The award-winning device is designed to require no patient assembly and can deliver biologics with viscosities up to 50 cP in both 2-5 mL and 5-10 mL configurations.

Ensifentrine Shows Promise in Improving Lung Function and COPD Symptoms

• A Phase 2b trial of ensifentrine demonstrated statistically significant improvements in lung function in COPD patients. • The study also met clinically relevant secondary endpoints, showing improvements in COPD symptoms. • Ensifentrine is a first-in-class, inhaled, dual inhibitor of phosphodiesterase 3 and 4, acting as both an anti-inflammatory and bronchodilator. • Verona Pharma anticipates an End-of-Phase 2 meeting with the FDA to discuss Phase 3 program design.

Chinese CDC Initiates Animal Testing for Novel Coronavirus mRNA Vaccine

  • Chinese researchers have begun animal testing of an mRNA vaccine targeting the novel coronavirus, with over 100 mice receiving injections in the initial screening phase.
  • The vaccine was co-developed by the Chinese CDC, Tongji University School of Medicine, and Stermirna Therapeutics Co Ltd, just two weeks after successfully isolating the first coronavirus strain.
  • Officials emphasize that animal testing represents a very early stage of vaccine development, with toxicity testing in larger animals and human clinical trials still required before potential use.
  • The mRNA vaccine platform offers a shorter development and production cycle compared to traditional vaccine approaches, as global research efforts intensify against the coronavirus outbreak.

J&J Hit with $187M Punitive Damages in Landmark Talc Cancer Trial

  • A New Jersey jury initially awarded $750 million in punitive damages against Johnson & Johnson in a talc-cancer case, later reduced to $187 million due to state law limitations.
  • Four plaintiffs who developed cancer after using J&J's talc products were previously awarded $37 million in compensatory damages in the same trial.
  • J&J's CEO Alex Gorsky made his first-ever jury trial appearance regarding talc litigation, while the company faces approximately 16,000 talc-related lawsuits amid ongoing safety concerns.

Immunology Market Evolution: Interleukin Inhibitors Rise as Biosimilars Reshape Treatment Landscape

  • The immunology market has witnessed a significant shift with increasing sales of interleukin inhibitors and declining TNF inhibitor revenues, driven by biosimilar competition and improved safety profiles.
  • Breakthrough research has expanded treatment options for previously underserved conditions, with notable approvals like Dupixient for atopic dermatitis and Benlysta for systemic lupus erythematosus.
  • Biosimilars have generated over $3.4 billion in sales by 2019, with Pfizer's Inflectra leading at $671 million, though market access challenges persist, particularly in the US.

PARP Inhibitors Show Similar Efficacy in BRCA-Mutated Ovarian Cancer, Cost-Effectiveness Varies

  • A network meta-analysis reveals no significant differences in efficacy among PARP inhibitor regimens for BRCA-mutated ovarian cancer patients in upfront or relapsed settings.
  • The ASCO value framework suggests similar clinical benefits and toxicity profiles across PARP inhibitor regimens in both upfront and relapsed settings.
  • Cost-effectiveness analysis indicates that adding bevacizumab to olaparib increases the cost per unit net health benefit compared to olaparib monotherapy in the upfront setting.
  • Upfront PARP inhibitor regimens demonstrate lower toxicity scores compared to those used in the relapsed setting, influencing treatment choice considerations.

RESMAIN Trial of Resminostat for CTCL Maintenance Continues After Positive Safety Review

  • The Data Safety Monitoring Board (DSMB) recommended the RESMAIN study of resminostat continue without modifications after reviewing safety data from the first 150 patients.
  • The RESMAIN trial evaluates resminostat as a maintenance treatment for advanced-stage cutaneous T-cell lymphoma (CTCL) patients who have achieved disease control with prior systemic therapy.
  • Enrollment in the RESMAIN study has been increased to 190 patients to minimize the time to unblinding, with top-line results expected by mid-2021.
  • A Phase II study of resminostat in biliary tract cancer in Japan, conducted by Yakult Honsha, has been discontinued, with no financial impact on 4SC.

US Biosimilar Market Reaches Critical Milestone: Key Learnings from 5 Years of Growth

  • The US biosimilar market has evolved significantly since Sandoz's Zarxio launch five years ago, with six major biosimilar launches occurring in recent months and potential cost savings of $54 billion through 2026.
  • Physician confidence remains a significant barrier to biosimilar adoption, with 74% of surveyed physicians citing it as a major challenge, highlighting the critical need for enhanced educational initiatives.
  • Strategic planning, comprehensive provider education, and continued advocacy efforts have emerged as crucial factors for successful biosimilar market penetration and sustainability.

Psilocybin Therapy Shows Sustained Mental Health Benefits for Cancer Patients Years After Single Dose

  • A single dose of psilocybin, combined with psychotherapy, shows significant, sustained improvements in emotional and existential distress in cancer patients.
  • Benefits from psilocybin therapy, including reduced anxiety, depression, and death anxiety, can last up to 4.5 years after administration.
  • Between 60% and 80% of participants experienced clinically significant reductions in depression or anxiety at the 4.5-year follow-up.
  • Participants reported the psilocybin-assisted therapy as one of the most meaningful and spiritually significant experiences of their lives.

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