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Clinical Trial News

NIH Awards $2.9 Million to ACRI for Cystic Fibrosis Therapy Research

  • The NIH has granted $2.9 million to ACRI to study how to improve the effectiveness of a key therapy for cystic fibrosis (CF).
  • The five-year study will investigate optimal dosing and potential genetic factors influencing response to triple combination therapy in CF patients.
  • Researchers aim to personalize CF treatment by understanding how individual patients process the drug and identifying the best dose for each person.
  • The study seeks to address the challenges of variable treatment response and side effects associated with triple combination therapy in CF patients.

Clesrovimab Shows Promise in Preventing RSV Infections in Infants

  • Clesrovimab significantly reduced RSV-associated medically attended lower respiratory infection (MALRI) by 60.4% compared to placebo in infants.
  • The monoclonal antibody reduced RSV-associated hospitalizations by 84.2% and lowered RSV-associated LRI hospitalizations by 90.9% through five months.
  • Interim data from a Phase 3 trial indicate that clesrovimab has a comparable safety profile to palivizumab in high-risk infants.
  • Merck anticipates clesrovimab could potentially be available for infants as early as the 2025-2026 RSV season, pending regulatory approvals.

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

NCT04767373CompletedPhase 2
Merck Sharp & Dohme LLC
Posted 4/7/2021

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

NCT04938830Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2021

Tryptamine Therapeutics Progresses Psilocin Drug Trials for Treatment-Resistant Depression

  • Tryptamine Therapeutics is advancing its clinical trials for psilocin, a psychedelic drug, targeting treatment-resistant depression.
  • The company is focusing on optimizing the delivery and therapeutic effects of psilocin to improve patient outcomes.
  • These trials represent a significant step forward in exploring alternative treatments for mental health disorders, addressing unmet needs.
  • Tryptamine Therapeutics aims to provide innovative solutions for patients who have not responded to traditional antidepressant therapies.

Lexicon Pharmaceuticals Licenses Sotagliflozin Rights to Viatris for Ex-US and Europe Markets

  • Lexicon Pharmaceuticals has licensed the rights for sotagliflozin outside the U.S. and Europe to Viatris for $25 million upfront, plus potential milestones and royalties.
  • The deal supports Lexicon's strategic shift towards expanding sotagliflozin's use, particularly in Type 1 diabetes with chronic kidney disease.
  • Viatris aims to strengthen its cardiovascular portfolio with sotagliflozin, which is currently marketed by Lexicon as Inpefa for heart failure and related conditions.
  • An FDA advisory panel will review sotagliflozin for glycemic control in Type 1 diabetes patients with chronic kidney disease, a market estimated at $400 million.

Epcoritamab Approved by FDA for Relapsed/Refractory Follicular Lymphoma

  • The FDA has granted accelerated approval to epcoritamab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
  • The approval was based on the phase 1/2 EPCORE NHL-1 trial, which demonstrated an 82% overall response rate and a 60% complete response rate.
  • Epcoritamab addresses a significant unmet need in follicular lymphoma, offering a new option with higher response rates compared to existing therapies.
  • As a bispecific antibody already approved for aggressive lymphomas, epcoritamab's integration into follicular lymphoma treatment is facilitated by existing familiarity among healthcare providers.

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

CONTACT-02: Cabozantinib Plus Atezolizumab Fails to Improve Overall Survival in mCRPC

  • The phase 3 CONTACT-02 trial evaluated cabozantinib plus atezolizumab versus a second novel hormonal therapy (NHT) in metastatic castration-resistant prostate cancer (mCRPC) patients.
  • While the combination met its progression-free survival (PFS) endpoint, it did not demonstrate a statistically significant overall survival (OS) benefit compared to second NHT.
  • Subgroup analysis suggested a potential survival advantage with the combination in patients with liver or bone metastases, warranting further investigation.
  • Cabozantinib plus atezolizumab may offer a novel mechanism of action for selected mCRPC patients progressing on NHT, particularly those with liver metastasis.

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

NCT04446117Active, Not RecruitingPhase 3
Exelixis
Posted 6/30/2020

FDA Approves Denileukin Diftitox (Lymphir) for Relapsed/Refractory Cutaneous T-Cell Lymphoma

  • The FDA has approved denileukin diftitox-cxdl (Lymphir) for relapsed/refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy.
  • Approval was based on the phase 3 Study 302, demonstrating a 36.2% objective response rate and an 8.7% complete response rate.
  • Denileukin diftitox re-enters the CTCL treatment landscape, offering robust responses for patients with limited options.

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma

NCT01871727CompletedPhase 3
Eisai Inc.
Posted 5/30/2013

Sage Therapeutics Restructures, Cuts Workforce Amid Pipeline Setbacks

• Sage Therapeutics is laying off one-third of its workforce and streamlining its early-stage drug pipeline after clinical and regulatory setbacks. • The restructuring follows the FDA's limited approval of Zurzuvae for postpartum depression and clinical failures of dalzanemdor in Alzheimer's and Parkinson's diseases. • Sage will prioritize the commercial launch of Zurzuvae and focus its pipeline development efforts on dalzanemdor for Huntington's disease. • The company anticipates incurring $26-28 million in restructuring costs in Q4 2024 to strengthen its financial position.

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

NCT05107128CompletedPhase 2
Sage Therapeutics
Posted 2/10/2022

A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

NCT05619692CompletedPhase 2
Sage Therapeutics
Posted 11/29/2022

A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment

NCT05318937CompletedPhase 2
Sage Therapeutics
Posted 6/6/2022

FDA Delays Full Approval Decision for Alfagigma's Ocaliva Following Negative AdComm

  • The FDA has delayed its decision on converting Ocaliva, a drug for primary biliary cholangitis, from accelerated to full approval after a negative advisory committee vote.
  • An FDA advisory committee voted against full approval of Ocaliva, citing that confirmatory trial data did not verify a clinical benefit.
  • The European Commission also revoked Ocaliva’s conditional marketing authorization in September following a negative recommendation from the EMA's Committee for Medicinal Products for Human Use.
  • Ocaliva, an FXR agonist, received accelerated approval in 2016 but has faced multiple setbacks, including a boxed warning due to incorrect dosing.

Positive Choices Trial Assesses Whole-of-School Intervention for Adolescent Mental Health

  • The Positive Choices trial is a phase III randomized controlled trial evaluating a whole-of-school intervention to improve adolescent mental health and well-being.
  • The intervention targets multiple levels, including students, teachers, and the school environment, to promote positive mental health and reduce psychological distress.
  • The trial's primary outcome is the change in psychological distress symptoms among adolescents, with secondary outcomes assessing well-being, academic outcomes, and school climate.
  • This comprehensive approach aims to provide a sustainable and scalable model for supporting adolescent mental health within the school setting.

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