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Clinical Trial News

Brain Training Game Shows Promise for Drug-Free Nerve Pain Treatment in First Clinical Trial

  • Researchers from the University of New South Wales developed PainWaive, an interactive brain training system that teaches patients to alter their brainwaves through neurofeedback games for nerve pain management.
  • In the first clinical trial, three out of four participants with corneal neuropathic pain experienced significant pain reductions five weeks after completing 20 treatment sessions over four weeks.
  • The system combines an EEG headset that records brain activity with an app featuring neurofeedback games, offering a potential non-invasive, in-home alternative to opioid treatments.
  • The promising results could lead to a new generation of drug-free treatments for chronic nerve pain conditions that rarely respond to current therapies.

Affinia Therapeutics Partners with DCM Foundation to Advance BAG3 Dilated Cardiomyopathy Awareness and Genetic Testing

Rare Disease
  • Affinia Therapeutics has partnered with the DCM Foundation and Genetic Cardiomyopathy Awareness Consortium to raise awareness about BAG3 dilated cardiomyopathy, a devastating monogenic heart disease affecting over 70,000 patients across the U.S., Europe, and U.K.
  • The collaboration aims to promote early diagnosis and genetic testing for BAG3 DCM, addressing the critical gap where only a fraction of cardiomyopathy patients receive genetic testing despite nearly 50% having a genetic basis.
  • The partnership will establish a BAG3 Patient Advisory Council and educational webinars while advancing Affinia's lead gene therapy candidate AFTX-201, a potential best-in-class AAV therapy delivered as a one-time intravenous injection.
  • Despite current standard of care, almost 25% of BAG3 DCM patients require heart transplant, highlighting the urgent need for innovative treatments and improved diagnostic approaches.

Jasper Therapeutics to Present Briquilimab Clinical Data at EAACI Congress 2025

Monoclonal Antibody
  • Jasper Therapeutics will present four abstracts on briquilimab at the EAACI Congress 2025 in Glasgow, featuring initial clinical data from the SPOTLIGHT Phase 1b/2a study.
  • The company will showcase results from the 180mg cohort evaluating briquilimab in cold urticaria and symptomatic dermographism patients who remain symptomatic despite antihistamine treatment.
  • Briquilimab is a novel anti-c-Kit monoclonal antibody that depletes mast cells through apoptosis, targeting the underlying inflammatory source in chronic urticaria and asthma.
  • The presentations will include both clinical trial data and preclinical studies demonstrating briquilimab's efficacy in mast cell-driven diseases including chronic spontaneous urticaria.

Zydus Lifesciences Secures Exclusive Rights to Agenus' BOT/BAL Cancer Immunotherapy for India and Sri Lanka

Monoclonal AntibodyOncology
  • Zydus Lifesciences has signed an exclusive licensing agreement with US-based Agenus Inc to commercialize the investigational cancer therapy combination of Botensilimab (BOT) and Balstilimab (BAL) in India and Sri Lanka.
  • The BOT/BAL combination therapy is currently in advanced clinical trials and has demonstrated significant clinical activity across nine cancer types in over 1,200 patients, including late-stage and neoadjuvant settings.
  • Under the agreement, Zydus will pay Agenus a 5% royalty on net sales following regulatory approval and will take responsibility for clinical development and regulatory approvals in the specified territories.
  • Zynext Ventures, the venture capital arm of Zydus, has also made a strategic investment in Agenus to accelerate development of the BOT/BAL programme and expand into high-unmet need indications.

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

NCT06251973RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 2/1/2024

Antheia Secures $56M Series C to Scale Synthetic Biology Platform for Critical Drug Manufacturing

  • Antheia raised $56 million in Series C funding led by Global Health Investment Corporation and EDBI to expand commercialization of its biosynthetic pharmaceutical ingredients platform.
  • The company's engineered yeast technology converts sugars into complex pharmaceutical ingredients, reducing production timelines from years to weeks while addressing global drug shortages.
  • Antheia achieved a commercial milestone with its first shipment of thebaine, a vital component in overdose-reversal medication Narcan, demonstrating scalability of its biomanufacturing platform.
  • The funding will support expansion of U.S. manufacturing operations and launch of 1-2 new products annually from a pipeline of over 70 biosynthetic pharmaceutical ingredients across seven therapeutic areas.

Sun Pharma Discontinues Psoriasis and Eczema Drug SCD-044 After Phase 2 Trial Failures

  • Sun Pharma's experimental oral drug SCD-044 (Vibozilimod) failed to meet primary endpoints in Phase 2 trials for both psoriasis and atopic dermatitis, missing the 75% improvement target in PASI and EASI scores at 16 weeks.
  • The company has discontinued further clinical development of SCD-044, which was considered one of the more promising assets in SPARC's specialty pipeline for inflammatory disorders.
  • SPARC shares plunged 19% following the disappointing results, while Sun Pharma and its R&D arm will reassess the compound's future despite the drug being generally safe and well tolerated.

Russia's Personalized mRNA Cancer Vaccine Set for Clinical Launch by October 2025

AI
  • Russia's Gamaleya Center plans to begin treating cancer patients with its personalized mRNA vaccine by September-October 2025, following regulatory approval expected this summer.
  • The vaccine uses AI-driven algorithms to create individualized mRNA blueprints based on patient genetic data, reducing development time from months to hours.
  • Pre-clinical trials demonstrated significant tumor suppression and prevention of metastases, with the vaccine designed to target over 300 histological and phenotypic cancer types.
  • The treatment will be provided free of charge to patients, representing a unique commitment to accessible cancer immunotherapy.

Allergan Botox Patent Infringement Trial Against Revance Set for July in Delaware

FDA Approval
  • A Delaware federal judge has ruled that Allergan's patent infringement lawsuit against Revance Therapeutics will proceed to trial in July 2024, following the denial of summary judgment motions from both parties.
  • The case centers on allegations that Revance's botulinum toxin product Daxxify infringes six Allergan patents related to Botox formulations and stabilization methods.
  • The court dismissed two Allergan entities from the litigation, leaving Allergan Inc. as the sole plaintiff after ruling that Allergan Ireland lacked standing due to insufficient proof of exclusive licensing rights.
  • Revance's Daxxify product received FDA approval for frown lines treatment in 2022 and cervical dystonia in 2023, despite delays caused by COVID-19 pandemic and inspection deficiencies.

Patent Trial and Appeal Board Institutes Review Against Halozyme in Merck Patent Dispute

  • The Patent Trial and Appeal Board has instituted a patent grant review (PGR) against Halozyme Therapeutics amid an ongoing patent infringement lawsuit with Merck & Co.
  • Wells Fargo analyst Mohit Bansal noted that the PGR institution likely reduces the probability of Halozyme prevailing in the patent infringement case.
  • Halozyme shares declined as much as 2.9% following the news, as winning the infringement suit had been considered a potential "bull case" for the company.
  • The development represents a setback for Halozyme's patent protection strategy, though the company has previously downplayed the significance of such proceedings.

TRexBio Initiates First-in-Human Trial of TRB-061, Novel TNFR2 Agonist for Atopic Dermatitis

  • TRexBio has dosed the first participant in a Phase 1a trial of TRB-061, a novel TNFR2 agonist designed to treat atopic dermatitis by selectively activating tissue regulatory T cells.
  • The randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, and pharmacokinetics of single ascending doses administered subcutaneously in healthy volunteers.
  • TRB-061 offers a potential new approach to immune modulation by expanding effector Tregs in tissues without stimulating other immune cells or causing broad immunosuppression.
  • Following Phase 1a completion, TRexBio plans to initiate a Phase 1b proof-of-concept trial in patients with moderate-to-severe atopic dermatitis, with safety data anticipated in the first half of 2026.

Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients

NCT06934252RecruitingPhase 1
TRex Bio, Inc.
Posted 5/2/2025

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