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Clinical Trial News

AstraZeneca Partners with Philippines to Establish First Pharmaceutical Innovation Hub in PEZA Ecozone

AIOncology
  • The Philippine Economic Zone Authority (PEZA) and AstraZeneca Pharmaceuticals Philippines have signed an agreement to create the country's first pharmaceutical innovation hub within the PEZA ecozone network.
  • The hub will serve as a regional center for digital health technology, research and development collaboration, and patient-centered healthcare solutions across ASEAN.
  • The initial project will be an Oncology Innovation Center using artificial intelligence for early cancer detection, modeled after AstraZeneca's pharma hub in the United Kingdom.
  • The partnership aims to make medicines more affordable and accessible while positioning the Philippines as a hub for healthcare-related investments and medical research.

FDA Rejects Blu Disposable E-Cigarette Marketing Application Over Dual-Use Concerns

FDA Approval
  • The FDA denied marketing authorization for Fontem US's Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette on August 19, citing insufficient evidence of public health benefits.
  • The agency determined that users would likely continue smoking cigarettes while using the Blu product, potentially exposing them to higher toxicant levels than exclusive cigarette use.
  • Fewer than 30 vaping products have received FDA marketing approval, with only four brands currently authorized: Juul, Altria's Njoy, Reynolds American's Vuse, and Japan Tobacco's Logic.
  • The FDA emphasized that authorized e-cigarettes must demonstrate complete switching from cigarettes or significant reduction in cigarette consumption to receive approval.

BlossomHill Therapeutics Advances EGFR-Mutant NSCLC Treatment with First-in-Class OMNI-EGFR Inhibitor BH-30643

Targeted TherapyOncology
  • BlossomHill Therapeutics has dosed the first patient in expansion cohorts of the SOLARA Phase 1/2 trial evaluating BH-30643, a first-in-class OMNI-EGFR inhibitor for advanced EGFR-mutant non-small cell lung cancer.
  • BH-30643 demonstrates sub-nanomolar potency against classical and atypical EGFR mutations while maintaining activity against T790M and C797S resistance mutations that commonly limit current therapies.
  • The expansion cohorts will assess objective response rates across diverse EGFR mutation subtypes, including treatment-naive patients, following successful dose escalation that showed favorable pharmacokinetics and preliminary anti-tumor activity.
  • The drug's broad-spectrum approach aims to address multiple EGFR mutations with a single agent while sparing wildtype EGFR and HER2 inhibition for improved tolerability.

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

NCT06706076RecruitingPhase 1
BlossomHill Therapeutics
Posted 1/9/2025

Novel Basket Trial Design Targets Multiple Rare Fibrotic Skin Diseases with Single Antifibrotic Therapy

  • A phase 2b multicenter basket trial proposes evaluating a common antifibrotic therapy across six rare fibrotic skin diseases that currently lack approved treatments.
  • The study employs a two-stage Simon design to address statistical challenges in small patient populations while maintaining analytical rigor for ultra-rare diseases.
  • Primary endpoints include a ≥21-point improvement in Investigator Global Assessment at 24 weeks, with secondary measures encompassing quality of life and symptom relief at 52 weeks.
  • This innovative approach could serve as a model for future rare disease research by leveraging shared pathophysiological features to enhance statistical power.

Gift Card Incentives Significantly Boost Low-Income Participation in Alzheimer's Clinical Trial Registry

  • University of Southern California researchers found that offering modest gift card incentives significantly increased enrollment of low-income individuals in an Alzheimer's disease patient registry designed to expedite clinical trials.
  • The study, published in JAMA Health Forum, demonstrates that simple financial incentives can effectively address barriers to participation and improve diversity in clinical research.
  • Enhanced representation of underrepresented populations in Alzheimer's trials could lead to more effective treatments tailored to different socioeconomic backgrounds and improve the generalizability of research findings.

Lighthouse Pharmaceuticals Secures $49.2 Million NIH Grant for Novel Alzheimer's Disease Treatment Targeting Bacterial Infection

Precision Medicine
  • Lighthouse Pharmaceuticals received a $49.2 million grant from the National Institute on Aging to advance Phase 2 trials of LHP588, targeting Porphyromonas gingivalis infections in Alzheimer's disease patients.
  • The SPRING trial will evaluate LHP588, an oral lysine-gingipain inhibitor, in 300 patients with mild to moderate Alzheimer's disease who test positive for P. gingivalis in saliva samples.
  • Previous clinical studies demonstrated that gingipain inhibitors significantly slowed cognitive decline in P. gingivalis-positive Alzheimer's patients, with bacterial reduction correlating to improved clinical outcomes.
  • The novel therapeutic approach targets the infectious and inflammatory cascade driven by P. gingivalis, which produces neurotoxic proteases that promote neuroinflammation and neurodegeneration in Alzheimer's disease.

Study of LHP588 in Subjects with P. Gingivalis-Positive Alzheimer's Disease

NCT06847321RecruitingPhase 2
Lighthouse Pharmaceuticals, Inc.
Posted 2/17/2025

Jyong Biotech's BOTRESO® Shows Promising Phase III Results for Benign Prostatic Hyperplasia Treatment

  • Jyong Biotech's botanical drug BOTRESO® demonstrated statistically significant improvement in lower urinary tract symptoms compared to placebo in Asian patients and pooled Taiwan-U.S. populations during Phase III trials.
  • The company's MCS-8 candidate met its primary efficacy endpoint in Phase II trials, showing lower rates of positive prostate biopsies and high-grade prostate cancer after 104 weeks of treatment.
  • BOTRESO® represents the first Taiwanese-developed oral botanical drug to receive FDA IND approval for Phase III trials, targeting a global BPH market projected to reach $9.8 billion by 2026.

Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)

NCT01002222CompletedPhase 3
Health Ever Bio-Tech Co., Ltd.
Posted 1/1/2011

MCS in the Treatment of Lower Urinary Tract Symptoms

NCT01002417CompletedPhase 2
Health Ever Bio-Tech Co., Ltd.
Posted 7/1/2010

Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

NCT01002664CompletedPhase 3
Health Ever Bio-Tech Co., Ltd.
Posted 5/1/2010

Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

NCT01002274CompletedPhase 3
Health Ever Bio-Tech Co., Ltd.
Posted 8/1/2010

Scientists Identify Protective Antibodies Against Strep A, Paving Way for Life-Saving Vaccine

  • Researchers at the University of Sheffield and MRC have identified specific antibodies that protect children against Strep A, a bacterial infection that kills 500,000 people annually worldwide.
  • The study tracked children in The Gambia and discovered that while maternal protection fades, young children rapidly develop immune responses to parts of the bacteria.
  • These findings, published in Nature Medicine, represent the first identification of protective antibodies in humans and could enable development of a vaccine to save hundreds of thousands of lives.
  • The breakthrough addresses a critical knowledge gap that has historically hindered vaccine development against this potentially deadly bacterial infection.

Invivyd Raises $57.5 Million to Advance Monoclonal Antibody Pipeline Targeting RSV, Measles, and Long COVID

Monoclonal Antibody
  • Invivyd completed a $57.5 million public offering in August 2025 to accelerate development of monoclonal antibody candidates for respiratory syncytial virus, measles, and Long COVID treatments.
  • The company aims to identify a best-in-class RSV monoclonal antibody candidate by Q3 2025, targeting a $3 billion global market opportunity by 2027.
  • Invivyd's SPEAR Study Group launched in July 2025 represents entry into the $10 billion+ Long COVID treatment market through collaboration with leading researchers.
  • The capital raise is paired with a $30 million non-dilutive term loan from Silicon Valley Bank, providing financial flexibility while minimizing equity dilution.

NuGen Medical Devices Develops Next-Generation Needle-Free Injection System with Internal Cartridge Technology

  • NuGen Medical Devices announced development of a next-generation needle-free injection system featuring integrated sterile internal insulin cartridges, protected under international patent WO2021206553.
  • The innovation eliminates external connectors and manual filling steps required by current systems like InsuJet, reducing dosing errors and contamination risks for patients requiring daily injections.
  • The company plans to produce working prototypes within six months and commence full tooling investment in early 2026, while beginning clinical investigations using their currently approved needle-free platform.
  • NuGen's flagship InsuJet system is already approved in 42 countries and designed to improve treatment for millions of diabetes patients worldwide.

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