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Clinical Trial News

Improved Diet Quality Linked to Reduced Hot Flashes in Postmenopausal Women

  • A study of postmenopausal women found that improved diet quality, particularly a plant-based diet, was associated with a reduction in the frequency of moderate-to-severe hot flashes.
  • The research involved a secondary analysis of a 12-week trial where participants were assigned to either a low-fat vegan diet or their usual diet, with dietary quality assessed using plant-based diet indices.
  • The findings suggest that dietary interventions focusing on enhancing diet quality may offer a non-hormonal approach to managing vasomotor symptoms in postmenopausal women.
  • Further analysis revealed correlations between specific food groups within the diet and changes in hot flash frequency, highlighting the potential impact of individual dietary components.

Adaptive Designs and mRNA Advancements Drive Innovation in Vaccine Clinical Trials

  • Novotech's report highlights a significant shift towards adaptive trial designs in vaccine development, enabling faster and more flexible responses to global health emergencies.
  • mRNA vaccine advancements are key to this shift, demonstrating the need for rapid and adaptable clinical trial frameworks, particularly after the COVID-19 pandemic.
  • Prophylactic vaccine trials are dominating the landscape with a 54.9% CAGR between 2019 and 2024, benefiting from the flexibility of adaptive designs.
  • AI is increasingly used to improve participant selection, data analysis, and real-time monitoring in vaccine trials, enhancing safety and efficacy.

Lupus Therapeutics Launches IDEAL Initiative to Study Diet's Impact on Lupus

  • Lupus Therapeutics has launched the IDEAL Initiative to fund clinical studies exploring the impact of diet on lupus management and patient experience.
  • The initiative will provide up to $500,000 over two years for pilot studies that assess dietary interventions and their effects on lupus.
  • The IDEAL Initiative encourages multidisciplinary research teams to investigate the mechanistic aspects of lupus related to diet and the microbiome.
  • The initiative aims to identify practical dietary approaches that can improve the standard of care and daily lives of individuals with lupus.

FDA Approves BridgeBio's Drug for Rare Heart Condition, Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

• The FDA has approved BridgeBio's drug for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and often fatal heart condition. • This approval marks a significant advancement in treating ATTR-CM, offering a new therapeutic option for patients with this disease. • The drug targets the underlying cause of ATTR-CM, aiming to stabilize transthyretin and prevent amyloid fibril formation in the heart. • The approval is based on clinical trial data demonstrating the drug's efficacy and safety in improving outcomes for ATTR-CM patients.

Lipella's LP-310 Shows Positive Phase 2a Results for Oral Lichen Planus

  • Lipella Pharmaceuticals' LP-310, a liposomal-tacrolimus oral rinse, demonstrated statistically significant improvements in treating oral lichen planus (OLP).
  • The Phase 2a trial showed improvements in patient-reported and investigator-measured efficacy endpoints, with a strong safety profile and no serious adverse events.
  • LP-310 is the only oral rinse topical treatment in development for OLP, which affects approximately 6 million Americans and has no FDA-approved therapies.
  • Lipella plans to advance the trial, submit a Phase 2b clinical trial application, and request Breakthrough Therapy designation from the FDA in 2025.

Evaluating LP-10 in Subjects With OLP

NCT06233591Active, Not RecruitingPhase 2
Lipella Pharmaceuticals, Inc.
Posted 7/1/2024

Novotech Report Highlights Trends in Global Vaccine Clinical Trials

  • Novotech's whitepaper analyzes the global vaccine clinical trial landscape, providing strategic insights for biotech and pharma companies.
  • The report identifies emerging trends such as adaptive trial designs and personalized vaccine approaches for infectious diseases and cancer.
  • Asia-Pacific's increasing role in therapeutic vaccine development is emphasized, along with streamlined regulatory processes post-COVID-19.
  • The whitepaper summarizes venture funding and M&A activity, focusing on investments in infectious disease and oncology vaccines.

Tango Therapeutics' PRMT5 Inhibitor TNG462 Shows Promise in Early Trials, Combination Studies Planned

• Tango Therapeutics' TNG462 demonstrates clinical activity in NSCLC and pancreatic cancer, with a 43% ORR in cholangiocarcinoma, showcasing a favorable safety profile. • Tango plans to initiate combination trials of TNG462 with RAS(ON) inhibitors from Revolution Medicines, osimertinib, and pembrolizumab in 1H 2025. • TNG908 shows clinical activity in non-CNS cancers, particularly pancreatic cancer, but development is deprioritized in favor of TNG462 due to its superior profile. • Tango's next-generation brain-penetrant PRMT5 inhibitor, TNG456, is set to begin phase 1/2 trials in 1H 2025, targeting glioblastoma and brain metastases.

Zanidatamab Shows Durable Response in HER2-Positive Biliary Tract Cancer

• Zanidatamab demonstrates a confirmed objective response rate of 41.3% in patients with pretreated, advanced HER2-positive biliary tract cancer. • The median duration of response to zanidatamab was 14.9 months, indicating a sustained clinical benefit for responding patients. • Median overall survival in patients with IHC 2+ or 3+ was 15.5 months, with 6- and 12-month OS rates of 80.3% and 56.2%, respectively. • The safety profile of zanidatamab remains consistent with previous reports, with manageable treatment-related adverse events.

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Montelukast (Singulair) Linked to Psychiatric Effects by FDA Researchers

  • FDA researchers have found that montelukast, known as Singulair, impacts multiple brain receptors critical for psychiatric function.
  • The asthma drug, originally marketed by Merck & Co., is widely prescribed and also available as a generic.
  • The findings suggest a potential link between montelukast and serious mental health problems, according to a Reuters report.

FDA Issues Complete Response Letter for Astellas' Avacincaptad Pegol; Aldeyra's Reproxalap NDA Accepted

  • The FDA issued a Complete Response Letter for Astellas Pharma's avacincaptad pegol intravitreal solution, indicating the sNDA cannot be approved in its current form.
  • Aldeyra Therapeutics' resubmitted NDA for topical ocular reproxalap, a first-in-class investigational candidate for dry eye disease, has been accepted by the FDA.
  • Aldeyra Therapeutics is expanding its option agreement with AbbVie, securing additional funding to support the commercialization of reproxalap.
  • Ocular imaging in emergency departments, utilizing non-mydriatic fundus cameras, enhances timely and accurate diagnoses, benefiting both patients and on-call ophthalmologists.

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