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Clinical Trial News

Etripamil Nasal Spray Shows Positive Phase III Results for PSVT Treatment in China

• Ji Xing Pharmaceuticals' Phase III trial of etripamil nasal spray met its primary endpoint, showing a statistically significant conversion to normal heart rhythm within 30 minutes compared to placebo. • The trial, conducted across 40 hospitals in China, demonstrated that 40.5% of patients converted to sinus rhythm with etripamil versus 15.9% with placebo. • Secondary efficacy endpoints were also met, with treatment-emergent adverse events being comparable between the etripamil and placebo groups, and no serious adverse events reported. • Ji Xing Pharmaceuticals plans to engage with regulatory authorities to advance the new drug application for etripamil, aiming to provide a self-managed treatment option for PSVT patients.

Ventyx Biosciences Initiates Phase 2a Trial of VTX3232 in Early Parkinson's Disease

  • Ventyx Biosciences has commenced a Phase 2a clinical trial of VTX3232 in patients with early Parkinson's disease, marking a significant step in neuroinflammatory disease treatment.
  • The open-label trial aims to enroll approximately ten patients over a 28-day treatment period, primarily assessing the safety and tolerability of VTX3232.
  • VTX3232, an oral, selective, CNS-penetrant NLRP3 inhibitor, is being evaluated for its potential to disrupt Parkinson’s disease pathology by targeting microglial NLRP3 activation.
  • Topline results from the Phase 2a trial, which include pharmacokinetic and biomarker assessments, along with exploratory PET neuroimaging, are expected in 2025.

KEYNOTE-789: Pembrolizumab Plus Chemotherapy Fails to Improve Survival in EGFR-Mutated NSCLC

  • The Phase 3 KEYNOTE-789 trial assessed pembrolizumab plus chemotherapy versus chemotherapy alone in patients with EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
  • The study did not meet its primary endpoint of overall survival (OS) in the pembrolizumab arm compared to the chemotherapy arm.
  • Progression-free survival (PFS) and objective response rate (ORR) were also similar between the two arms, indicating no significant benefit from adding pembrolizumab.
  • These findings suggest that pembrolizumab plus chemotherapy is not an effective treatment strategy for EGFR-mutated metastatic NSCLC after progression on EGFR-TKI therapy.

Palatin Technologies Advances Pipeline with Focus on Dry Eye, Obesity, and Sexual Dysfunction

  • Palatin Technologies is advancing PL9643 for dry eye disease, with Phase III trials set to begin in early 2025 and NDA filing anticipated in the first half of 2026.
  • A Phase II study combining bremelanotide with tirzepatide for obesity treatment is underway, with results expected in early 2025, exploring synergistic weight loss effects.
  • Palatin is developing a co-formulation of bremelanotide with a PDE-5 inhibitor for erectile dysfunction, targeting patients unresponsive to PDE-5 inhibitor monotherapy.
  • The company reported a net loss for Q4 2024 but highlighted reduced operating expenses and progress in multiple therapeutic areas, including ocular health and obesity.

Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

NCT05466890Active, Not RecruitingPhase 2
Palatin Technologies, Inc
Posted 9/15/2022

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

NCT05709444CompletedPhase 2
Palatin Technologies, Inc
Posted 12/26/2022

A Phase 2 Study Evaluating the Co-Administration of Bremelanotide with Tirzepatide for the Treatment of Obesity

NCT06565611Active, Not RecruitingPhase 2
Palatin Technologies, Inc
Posted 8/5/2024

DEA Approves Increased Production of Vyvanse Amid ADHD Drug Shortages

  • The DEA has approved Takeda Pharmaceuticals to increase production of Vyvanse by 24% to address ongoing shortages of ADHD medications.
  • This decision follows a request from the FDA in July to ensure an adequate supply of lisdexamfetamine for both domestic and global needs.
  • The increased production limit includes 6236 kg for domestic demand and 4678 kg for foreign demand of finished dosage medications.
  • Generic versions of Vyvanse have been approved from 11 drugmakers after Takeda lost exclusivity last year.

New Clinical Studies and Classification Criteria Advance Understanding of Axial PsA Treatment

  • Leading research reveals that axial inflammation affects up to 40% of psoriatic arthritis patients, prompting efforts to establish clearer diagnostic criteria based on clinical features, imaging findings, and genetic markers.
  • Phase 2 ARGO study of sonelokimab and phase 4 STAR study of guselkumab are among key upcoming trials investigating new treatment options for axial psoriatic arthritis.
  • Collaborative efforts between major rheumatology research groups are developing new classification criteria for axial PsA to improve disease understanding and treatment approaches.

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

NCT04929210RecruitingPhase 4
Janssen Research & Development, LLC
Posted 8/30/2021

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

NCT05640245CompletedPhase 2
MoonLake Immunotherapeutics AG
Posted 12/13/2022

AI-Driven Drug Discovery Shows Promise and Challenges in Cerebral Cavernous Malformation Trial

• Recursion Pharmaceuticals' Phase 2 trial of REC-994 for cerebral cavernous malformation (CCM) met its primary safety endpoint but showed mixed efficacy results. • The trial highlights the potential and challenges of using AI to analyze vast datasets for identifying new drug candidates for rare diseases. • Experts suggest combining AI with traditional techniques and developing more complex models to improve the accuracy and reliability of AI-driven drug discovery. • Accessibility of AI tools is crucial, with platforms streamlining the process for scientists to efficiently utilize these technologies in drug discovery.

EU Court Temporarily Suspends Ban on Ocaliva for Primary Biliary Cholangitis

  • The EU Court of Justice has temporarily suspended the European Commission's ban on Ocaliva, a drug used to treat primary biliary cholangitis (PBC).
  • The ban was initially implemented following an EMA review that questioned Ocaliva's efficacy in preventing disease progression in early-stage PBC patients.
  • Advanz Pharma, the manufacturer of Ocaliva, challenged the ban, arguing the drug provides a crucial second-line treatment option for PBC patients.
  • The suspension ensures Ocaliva remains available to EU patients while the court reviews Advanz Pharma's lawsuit against the Commission's decision.

Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

NCT01473524CompletedPhase 3
Intercept Pharmaceuticals
Posted 1/1/2012

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

NCT02308111TerminatedPhase 4
Intercept Pharmaceuticals
Posted 12/26/2014

Strides Pharma Secures USFDA Approval for Generic Theophylline Extended-Release Tablets

  • Strides Pharma Global, a subsidiary of Strides Pharma Science, has received USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg, a generic version of Schering Corp's THEO-DUR.
  • These tablets are indicated for managing symptoms and reversible airflow obstruction linked to chronic asthma and other chronic lung diseases like emphysema and chronic bronchitis.
  • The combined market for Theophylline Extended-Release Tablets, 300 mg and 450 mg, is approximately $11.5 million, with the 300 mg dosage accounting for $10.8 million.
  • Manufacturing of the tablets will occur at Strides Pharma's facility in Bengaluru, India, ensuring a steady supply of this essential medication.

Colchicine's Tolerability Unaffected by Common Drug Interactions in COVID-19 Patients

  • A secondary analysis of the COLCORONA trial assessed the impact of drug-drug interactions on colchicine's safety and efficacy in COVID-19 patients.
  • The study found that common interactions with statins and calcium channel blockers did not significantly increase adverse events with colchicine.
  • Drug-drug interaction status did not modify colchicine's effect on COVID-19 hospitalization or death, suggesting clinical tolerability.
  • Findings suggest low-dose colchicine can be safely used with certain interacting drugs in closely monitored, select patients.

Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

NCT04322682TerminatedPhase 3
Montreal Heart Institute
Posted 3/23/2020

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