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Clinical Trial News

pH-D Feminine Health Initiates First FDA-Cleared Phase 3 Trial for Boric Acid Suppositories in Yeast Infections

  • pH-D Feminine Health has launched the first FDA-cleared Phase 3 clinical trial to validate boric acid suppositories as a treatment for yeast infections, marking a critical milestone in women's health research.
  • The randomized, placebo-controlled, double-blinded study aims to generate clinical evidence supporting a New Drug Application submission for boric acid suppositories.
  • Enrollment has begun at nearly 20 trial sites nationwide, with study completion anticipated by June 2026, addressing a decades-long gap in clinical evidence for this treatment option.
  • Both the American College of Obstetricians and Gynecologists and the Centers for Disease Control and Prevention recognize boric acid as an effective option for managing vaginal yeast infections in non-pregnant women.

Acumen Pharmaceuticals Advances Alzheimer's Pipeline with JCR Partnership and ALTITUDE-AD Phase 2 Trial

Monoclonal Antibody
  • Acumen Pharmaceuticals expects topline results from its Phase 2 ALTITUDE-AD study evaluating sabirnetug for early Alzheimer's disease in late 2026, with the trial having enrolled 542 participants.
  • The company announced a collaboration with JCR Pharmaceuticals to develop Enhanced Brain Delivery therapy combining Acumen's oligomer-targeting antibodies with JCR's blood-brain barrier-penetrating technology.
  • Sabirnetug demonstrated 8,750-fold selectivity for amyloid beta oligomers over monomers and achieved the highest binding affinities among tested monoclonal antibodies in surface plasmon resonance testing.
  • The company maintains $166.2 million in cash reserves expected to support operations into early 2027, while implementing cost-efficient screening strategies that reduced trial costs by approximately 40%.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

Lung Fibrosis Drug Pirfenidone Shows Promise as COPD Treatment Alternative to Steroids

  • Researchers at Hudson Institute of Medical Research discovered that Pirfenidone, a drug used to treat lung fibrosis, effectively reduces both viral replication and airway inflammation in COPD without suppressing immune response.
  • The pre-clinical study found Pirfenidone outperformed steroids in managing COPD exacerbations while avoiding the severe side effects associated with long-term steroid use, including diabetes, hypertension, and osteoporosis.
  • COPD affects approximately 2 million Australians and current steroid treatments create a paradox by reducing inflammation but encouraging viral replication during exacerbations.
  • The findings, published in the American Journal of Respiratory Cell and Molecular Biology, suggest Pirfenidone could allow patients to discontinue steroids and prevent severe COPD flares that can lead to premature death.

Early Long COVID Trials of Paxlovid and Monoclonal Antibodies Show No Significant Benefits, But Research Continues

Monoclonal Antibody
  • Three prominent clinical trials testing Paxlovid and monoclonal antibodies for Long COVID failed to show significant health improvements compared to placebo groups.
  • The trials were designed as "proof of concept" studies to test viral persistence theory, with researchers acknowledging they expected challenging results but hoped for better outcomes.
  • Future trials are being designed with longer treatment durations, larger patient populations, and more specific biomarkers to better target viral persistence in Long COVID patients.
  • New monoclonal antibody trials are underway, including sipavibart at Nova Southeastern University and planned studies with Pemgarda, which may offer longer-lasting effects than short-course antivirals.

HOPE Trial Extends Alteplase Treatment Window to 24 Hours for Acute Ischemic Stroke Patients

  • The HOPE trial demonstrated that alteplase administration up to 24 hours after acute ischemic stroke onset significantly improves functional independence rates in appropriately selected patients.
  • Results showed 40.3% of alteplase-treated patients achieved functional independence at 90 days compared to 26.3% receiving standard care, despite higher rates of symptomatic intracranial hemorrhage.
  • The findings support extending the therapeutic window for IV thrombolysis when endovascular thrombectomy is not initially planned or available, particularly benefiting resource-limited settings.
  • Experts note the results are most applicable in low-to-middle-income countries where thrombectomy services are unavailable due to insufficient resources or long transfer times.

Gameto Secures $44M Series C Funding as Stem Cell IVF Therapy Fertilo Advances to Phase 3 Trial

  • Gameto completed a $44 million Series C funding round led by Overwater Ventures, bringing total capital raised to $127 million for its stem cell-derived reproductive health therapies.
  • The company's lead therapy Fertilo uses engineered ovarian support cells from induced pluripotent stem cells to mature eggs outside the body, reducing standard IVF hormone protocols from two weeks to 2-3 days.
  • Fertilo has already resulted in five births and over 20 pregnancies across international markets, and is now entering the first randomized controlled Phase 3 trial for ex vivo egg maturation in the United States.
  • The therapy represents the first iPSC-derived treatment to reach late-stage clinical development in the US, with interim trial results expected in late 2026.

Fertilo In Vitro Research Study and Trial

NCT06858111RecruitingPhase 3
Gameto, Inc.
Posted 4/17/2025

HHS Halts Vaxart's $460 Million Oral COVID-19 Vaccine Trial Amid Federal mRNA Program Rollback

  • The Department of Health and Human Services issued a stop work order on August 5, 2025, halting Vaxart's Phase IIb trial for VXA-CoV2-3.3, an oral COVID-19 vaccine that had enrolled approximately 5,000 of its targeted 10,000 participants.
  • The order coincided with HHS's announcement to wind down mRNA vaccine development activities under BARDA, canceling over 20 projects worth nearly $500 million combined.
  • This marks the second regulatory freeze for Vaxart's oral vaccine program, following a previous stop work order in February 2025 that was lifted in April, highlighting ongoing regulatory uncertainty for the $460.7 million BARDA-funded project.
  • Vaxart's investigational pill vaccine is designed to provide broad protection against SARS-CoV-2 variants and reduce viral transmission, representing a novel oral delivery approach compared to existing injectable COVID-19 vaccines.

X4 Pharmaceuticals Secures $60 Million Financing and Installs New Leadership Team

Rare DiseaseLeadership Change
  • X4 Pharmaceuticals announced a $60 million private placement financing led by Coastlands Capital, Bain Capital Life Sciences, and New Enterprise Associates to support continued development of mavorixafor.
  • The company simultaneously appointed a new leadership team including Dr. Adam Craig as Executive Chairman, John Volpone as President, and David Kirske as Chief Financial Officer, all formerly of CTI BioPharma.
  • The financing will fund continued development toward potential approval of mavorixafor in chronic neutropenia, in addition to commercialization of XOLREMDI for WHIM syndrome.
  • X4's CXCR4 antagonist mavorixafor is currently undergoing a global Phase 3 clinical trial (4WARD) in chronic neutropenic disorders while being marketed as XOLREMDI in the U.S.

Airway Therapeutics Secures EMA Pediatric Approval for First-in-Class BPD Prevention Therapy

  • The European Medicines Agency's Pediatric Committee has approved Airway Therapeutics' Pediatric Investigation Plan for zelpultide alfa, a first-in-class recombinant human surfactant protein D therapy designed to prevent bronchopulmonary dysplasia in very preterm infants.
  • The approved plan includes a pivotal Phase 2b/3 clinical trial evaluating two dose levels in 150 patients initially, with one dose advancing to Phase 3 enrollment of approximately 216 additional patients.
  • Zelpultide alfa addresses a critical unmet medical need as no approved preventative treatments currently exist for bronchopulmonary dysplasia, one of the most challenging complications in neonatal intensive care.
  • The multinational study is set to begin in late Q3/Q4 2025, with initial submissions planned for Italy, Spain, and Israel, followed by additional countries including France, Germany, and the United States.

Efficacy of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)

NCT06897839Active, Not RecruitingPhase 3
Airway Therapeutics, Inc.
Posted 2/3/2025

FDA Approves Expansion of Aquedeon's Duett Vascular Graft System Trial to 90 Patients

FDA Approval
  • The FDA has approved expansion of Aquedeon Medical's IDE clinical trial for the Duett Vascular Graft System, increasing enrollment from the initial study to up to 90 patients across additional U.S. clinical sites.
  • The Duett System is designed to simplify and accelerate vascular anastomosis during complex aortic arch reconstruction surgery, potentially reducing deep hypothermic circulatory arrest duration and associated neurological risks.
  • The novel device addresses critical needs in open surgical repair of aortic arch aneurysms and dissections, procedures that are technically demanding and carry significant cardiac and neurological risks.
  • Principal investigator Dr. Wilson Szeto notes the technology has potential to transform aortic surgery by providing surgeons with innovative tools to enhance patient care for aortic disease.

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