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Clinical Trial News

SetPoint Medical's Neuroimmune Modulation Platform Receives EULAR Clinical Research Award for Rheumatoid Arthritis Trial

  • SetPoint Medical received the EULAR Abstract Award in the Clinical Research category for its RESET-RA study, marking the first randomized, sham-controlled, double-blind trial to positively demonstrate neuroimmune modulation for rheumatoid arthritis treatment.
  • The company's SetPoint System targets patients with inadequate response or intolerance to biological or targeted synthetic DMARDs, presenting 12- and 24-week safety and efficacy results.
  • The platform technology stimulates the vagus nerve to activate neuroimmune pathways, producing systemic anti-inflammatory effects as a potential treatment alternative for chronic autoimmune conditions.
  • Dr. David Chernoff will present the study results at EULAR 2025 Congress on June 12, highlighting the clinical potential of this novel therapeutic approach.

FDA Approves MAVYRET as First Treatment for Acute Hepatitis C with 96% Cure Rate in Eight Weeks

Drug Approval
  • The U.S. FDA approved an expanded indication for AbbVie's MAVYRET (glecaprevir/pibrentasvir), making it the first and only oral eight-week pangenotypic treatment approved for people with acute hepatitis C virus infection.
  • The approval was supported by Phase 3 trial data showing a 96% cure rate in 286 treatment-naïve adult patients with acute HCV infection treated for eight weeks.
  • MAVYRET received FDA Breakthrough Therapy Designation for acute HCV treatment, designed to expedite development of medicines that demonstrate substantial improvement over existing therapies.
  • The expanded indication supports global clinical guidelines for universal HCV treatment and public health goals to eliminate hepatitis C as a public health problem by 2030.

Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

NCT04903626CompletedPhase 3
AbbVie
Posted 8/24/2021

Zeteo Biomedical Secures Global Patents for Advanced Drug Delivery Technologies Supporting Space-Based Healthcare

  • Zeteo Biomedical received new US and EU patents for its ZTech drug delivery platform, strengthening its portfolio of nasal, ophthalmic, and sublingual delivery devices.
  • The patented technologies enable reliable medication delivery in any physical orientation, including space-based microgravity environments, opening new frontiers for space healthcare applications.
  • The ZTech-L and ZTech-P platforms support both liquid and dry powder formulations for vaccines, biologics, and specialty drugs targeting conditions like pain, seizures, and neurodegenerative disorders.
  • The company's patient-friendly design approach aims to improve treatment adherence and medical outcomes while meeting increasing global demand for compact, self-administered delivery devices.

Nanobody Platform Enhances Cancer Immunotherapy Through Albumin Hitchhiking and STING Activation

  • Vanderbilt researchers developed albumin-hitchhiking nanobodies that extend circulation time from 5 minutes to 55 hours and achieve 11% injected dose per gram tumor accumulation.
  • The nanobody-STING agonist conjugates demonstrated complete tumor elimination in 100% of breast cancer models and significant efficacy against melanoma metastases.
  • A bivalent nanobody targeting both albumin and PD-L1 showed superior therapeutic outcomes, generating immunological memory that prevented tumor recurrence in 89% of treated mice.
  • The platform activated CD8+ T cells and NK cells as primary antitumor effectors while stimulating antigen-specific memory responses against tumor-associated antigens.

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

NCT03843359Active, Not RecruitingPhase 1
GlaxoSmithKline
Posted 3/12/2019

Chiesi Group and Key2Brain Expand Partnership with Worldwide Licensing Deal for Blood-Brain Barrier-Crossing Therapies

  • Chiesi Group and Key2Brain announced a worldwide licensing agreement to develop blood-brain barrier-crossing enzyme replacement therapies for ultra-rare lysosomal storage disorders including alpha-mannosidosis and Krabbe disease.
  • The collaboration builds on a 2022 partnership and positive in vivo proof-of-concept data demonstrating Key2Brain's proprietary BBB-crossing technology platform using engineered VHH antibodies targeting the transferrin receptor.
  • Under the agreement, Chiesi will fund all research, development and commercialization worldwide while Key2Brain receives upfront payments, milestone payments and tiered royalties on potential sales.
  • The partnership addresses significant unmet medical needs in neurodegenerative manifestations of ultra-rare diseases where many families currently have no therapeutic options available.

Cabaletta Bio Launches Public Offering to Fund CAR-T Cell Therapy Development for Autoimmune Diseases

CAR-T
  • Cabaletta Bio announced an underwritten public offering of common stock and warrants on June 11, 2025, with expected closing on June 12, 2025.
  • The clinical-stage biotechnology company is developing the first curative targeted cell therapies specifically designed for patients with autoimmune diseases.
  • The company's lead therapy rese-cel is a fully human CD19-CAR T cell investigational treatment being evaluated in the RESET clinical program.
  • The RESET program spans multiple therapeutic areas including rheumatology, neurology, and dermatology for autoimmune disease treatment.

A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

NCT07159763Not Yet RecruitingNot Applicable
Cidara Therapeutics Inc.
Posted 9/1/2025

Graves Disease Pipeline Shows Promise with 10+ Therapies in Development as TED Treatments Gain Regulatory Momentum

Monoclonal AntibodyDrug Approval
  • DelveInsight's 2025 pipeline analysis reveals 8+ key companies are developing 10+ novel Graves Disease treatment therapies across various clinical development phases.
  • Recent regulatory milestones include Amgen's TEPEZZA approval by UK MHRA for thyroid eye disease and FDA's breakthrough therapy designation for Viridian's veligrotug.
  • Emerging therapies targeting IGF-1R pathway show clinical promise, with Sling Therapeutics' linsitinib demonstrating favorable safety profile in over 900 patients across 15 trials.
  • Pipeline includes diverse therapeutic approaches spanning monoclonal antibodies, small molecules, and gene therapy with multiple routes of administration under investigation.

EssilorLuxottica Acquires European Ophthalmology Network Optegra to Advance Med-Tech Strategy

AI
  • EssilorLuxottica has entered into an agreement to acquire Optegra Eye Health Care, a European ophthalmology platform operating over 70 facilities across five markets including the UK, Czech Republic, Poland, Slovakia, and the Netherlands.
  • The acquisition supports EssilorLuxottica's medical technology strategy expansion, combining comprehensive eye care with advanced diagnostics and AI-powered surgical treatments in a unified platform.
  • Optegra's network provides ophthalmic treatments including cataract surgery, glaucoma treatments, age-related macular degeneration therapies, and laser eye surgery with artificial intelligence integration in pre- and post-operative stages.
  • The transaction is expected to close in 2025 pending regulatory approvals and will enable EssilorLuxottica to leverage AI and big data capabilities for personalized patient care and detection of conditions ranging from neurodegenerative diseases to cardiovascular dysfunction.

Simtra BioPharma Solutions and MilliporeSigma Form Strategic Alliance to Streamline ADC Manufacturing

Monoclonal Antibody
  • Simtra BioPharma Solutions and MilliporeSigma have established a five-year strategic alliance to create a turnkey offering for antibody-drug conjugate manufacturing and bioconjugation services.
  • The partnership aims to address the complexity of ADC manufacturing by creating a seamless value chain where MilliporeSigma handles drug substance conjugation and Simtra manages fill-finish operations.
  • With over 200 ADCs currently in clinical trials and the ADC manufacturing market expected to grow from $1.79 billion to $7 billion by 2035, the alliance targets significant industry demand.
  • The collaboration is designed to reduce development timelines and complexity for biopharmaceutical companies, allowing them to focus on drug discovery while ensuring quality standards.

Elkedonia Raises €11.25 Million to Develop Novel Neuroplastogen Therapy for Treatment-Resistant Depression

Precision Medicine
  • Elkedonia closed an oversubscribed €11.25 million seed funding round to advance first-in-class neuroplastogen therapeutics targeting the Elk1 protein for treatment-resistant depression.
  • The company's approach targets neuroplasticity restoration without the side effects of psychedelics or ketamine, addressing the needs of approximately 100 million patients globally who don't respond to current treatments.
  • The Franco-Belgian startup leverages research from Sorbonne University and plans to develop precision medicine biomarkers alongside small molecule inhibitors of the intracellular Elk1 target.
  • Major depressive disorder affects 300 million people worldwide, with suicide being the third leading cause of death among 15-29 year-olds, highlighting the urgent need for innovative therapeutic solutions.

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