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Clinical Trial News

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

  • 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.
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.
NCT01002417CompletedPhase 2
Health Ever Bio-Tech Co., Ltd.
Posted 7/1/2010
NCT01002664CompletedPhase 3
Health Ever Bio-Tech Co., Ltd.
Posted 5/1/2010

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

  • 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.

Vaginal Estrogen Tablets Show No Increased Stroke Risk for Postmenopausal Women with Prior Stroke History

  • A Danish registry study of over 34,000 postmenopausal women found that vaginal estrogen tablets were not associated with increased risk of recurrent ischemic stroke in women with prior stroke history.
  • The research addresses a critical knowledge gap for a vulnerable population often excluded from hormone therapy studies, examining women aged 45 and older who had experienced their first stroke between 2008-2017.
  • Unlike systemic hormone replacement therapy which is contraindicated after stroke, vaginal estrogen tablets showed no significant association with stroke recurrence across current, recent, or past use categories.
  • The findings may reassure healthcare providers treating menopausal symptoms in stroke survivors, though researchers emphasize the need for cautious interpretation of real-world data.

Cyclophilin Inhibitor Shows Promise for Reversing Alcohol-Related Liver Fibrosis in Human Tissue Models

  • Researchers at King's College London demonstrated that cyclophilin inhibitors can reverse key features of alcohol-related liver disease by reducing fibrotic protein accumulation in human tissue models.
  • The study used precision-cut liver slices and isolated hepatic stellate cells from human liver tissue to show the drug's ability to alter tissue structure and reduce fibrogenic activity.
  • These findings provide new mechanistic insights into cyclophilin inhibitors' therapeutic potential for treating alcohol-related liver fibrosis, a condition with no currently approved medical therapies.
  • The use of human-derived 3D models offers high clinical relevance compared to traditional animal studies, potentially accelerating translation to clinical applications.

Oral Testosterone Undecanoate Shows Superior Sexual Function Improvements in Phase 3 Trial

  • Oral testosterone undecanoate (Jatenzo) significantly improved serum testosterone levels, with 92% of men achieving levels of 450 ng/dL or higher by day 105 in the inTUne phase 3 trial.
  • Sexual activity scores increased by 1.85 points from baseline to day 105, representing a clinically meaningful improvement that exceeded results seen in the TRAVERSE trial.
  • All eight sexual function domains showed significant improvements, including sexual desire, pleasure, erection quality, and mood parameters.
  • The study provides important efficacy data for oral testosterone therapy, which represents a relatively new treatment option in the United States after decades without FDA-approved oral formulations.

XOMA Royalty Acquires Mural Oncology for $36.2 Million in Strategic Biotech Consolidation

  • XOMA Royalty's subsidiary XRA 5 Corp. will acquire clinical-stage immuno-oncology company Mural Oncology for $2.035 per share base price, potentially reaching $36.2 million total value.
  • The acquisition represents a 13.1% premium over Mural's recent share price and a 97.6% premium over pre-strategic review value, maximizing shareholder returns.
  • This deal continues XOMA's aggressive 2025 acquisition strategy, following recent mergers with HilleVax and Turnstone Biologics to expand its late-stage biotech portfolio.

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