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Clinical Trial News

FDA Grants Fast Track Designation to Elevation Oncology's EO-3021 for Gastric and GEJ Cancers

• The FDA has granted Fast Track designation to EO-3021 for advanced or metastatic gastric and gastroesophageal junction (GEJ) cancer expressing Claudin 18.2. • EO-3021, a differentiated antibody-drug conjugate, targets Claudin 18.2, a protein exposed in malignant transformation of gastric epithelial cells. • The Fast Track designation aims to expedite the development and review of EO-3021, offering potential for priority review and accelerated approval. • Early Phase 1 trial results showed a 42.8% overall response rate in a Claudin 18.2-enriched subset of gastric and GEJ cancer patients.

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

NCT05980416TerminatedPhase 1
Elevation Oncology
Posted 8/10/2023

Brepocitinib Shows Promise in Non-Infectious Uveitis: Phase 3 Trial Initiated

  • Priovant Therapeutics' brepocitinib demonstrated significant treatment failure reductions in the Phase 2 NEPTUNE trial for non-infectious uveitis.
  • The CLARITY Phase 3 trial has been initiated to further evaluate brepocitinib's efficacy against non-anterior non-infectious uveitis, comparing 45mg dose to placebo.
  • Brepocitinib received Fast Track Designation from the FDA, expediting its development for non-infectious uveitis due to unmet medical needs.
  • The dual TYK2/JAK1 inhibitor showed a dose-dependent improvement in retinal vascular leakage, as measured by fluorescein angiography, in the NEPTUNE trial.

A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis

NCT05523765CompletedPhase 2
Priovant Therapeutics, Inc.
Posted 11/14/2022

A Phase 3 Study of Brepocitinib in Adults with Active, Non-Infectious, Non-Anterior Uveitis (CLARITY)

2024-515089-15-00Not Yet RecruitingPhase 3
Priovant Therapeutics Inc.

uniQure's AMT-191 Receives FDA Orphan Drug Designation for Fabry Disease

  • The FDA has granted Orphan Drug Designation to uniQure's AMT-191, a gene therapy for Fabry disease, highlighting the need for innovative treatments.
  • AMT-191 is a one-time, intravenously administered AAV5-based gene therapy designed to target the liver and produce the deficient GLA protein.
  • A Phase I/IIa clinical trial is underway in the U.S. to assess the safety, tolerability, and early efficacy of AMT-191, with initial data expected in 2025.
  • Orphan Drug Designation provides uniQure with incentives, including tax credits and market exclusivity, to support the development of AMT-191.

Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease

NCT06270316RecruitingPhase 1
UniQure Biopharma B.V.
Posted 6/5/2024

Heidelberg Pharma's HDP-101 Shows Promise in Relapsed Multiple Myeloma

  • Heidelberg Pharma's HDP-101, an anti-BCMA antibody-drug conjugate, demonstrates biological activity in relapsed or refractory multiple myeloma patients.
  • Early data from a Phase I/IIa trial shows objective improvement in disease, with one patient achieving partial remission in cohort five.
  • The ongoing trial is evaluating HDP-101's safety and efficacy, with further data expected at upcoming scientific conferences.
  • Heidelberg Pharma will host an R&D webinar on October 15, 2024, to discuss the HDP-101 clinical trial results and future development plans.

Prestige BioPharma's Tuznue Receives European Commission Approval as Herceptin Biosimilar

  • Prestige BioPharma's Tuznue (trastuzumab) has been granted final approval by the European Commission as a biosimilar to Herceptin, a drug used to treat breast and metastatic gastric cancers.
  • Tuznue is the third trastuzumab biosimilar approved in Europe, positioning Prestige BioPharma to compete in a market valued at approximately $4.1 billion annually.
  • The company plans to leverage Tuznue's approval to accelerate marketing authorization for its Avastin biosimilar, HD204 (bevacizumab), currently undergoing Phase 3 trial analysis.
  • Prestige BioPharma anticipates generating revenue through licensing agreements with global pharmaceutical companies and aims for price competitiveness to capture market share.

Fruquintinib Approved in Japan for Previously Treated Metastatic Colorectal Cancer

  • Takeda's Fruzaqla (fruquintinib) has been approved in Japan for advanced or recurrent colorectal cancer (CRC) after chemotherapy.
  • The approval is based on the Phase III FRESCO-2 trial, which demonstrated statistically significant improvements in overall and progression-free survival.
  • Fruquintinib is the first novel targeted therapy approved in Japan for metastatic CRC, regardless of biomarker status, in over a decade.
  • This approval expands the global availability of fruquintinib, offering a new treatment option for patients with limited alternatives.

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

NCT04322539CompletedPhase 3
Hutchison Medipharma Limited
Posted 8/12/2020

Alkermes Presents Positive Phase 1b Data for ALKS 2680 in Narcolepsy Type 2 and Idiopathic Hypersomnia

  • Alkermes' ALKS 2680 demonstrates improved wakefulness compared to placebo in patients with narcolepsy type 2 (NT2) in a Phase 1b study.
  • The Phase 1b study also showed ALKS 2680 was generally well-tolerated in patients with idiopathic hypersomnia (IH), with positive signals on wakefulness.
  • Alkermes is advancing ALKS 2680 into Phase 2 trials (Vibrance-1 and Vibrance-2) to further evaluate its efficacy and safety in narcolepsy type 1 and type 2.
  • ALKS 2680 is a novel, oral, selective orexin 2 receptor agonist being developed as a once-daily treatment for narcolepsy and other hypersomnolence disorders.

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

NCT06358950CompletedPhase 2
Alkermes, Inc.
Posted 3/28/2024

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783RecruitingPhase 2
Alkermes, Inc.
Posted 7/26/2024

FDA's sIRB Mandate to Spur Reassessment of Clinical Trial Site Performance

  • The FDA's anticipated sIRB mandate, expected by May 2025, will shift IRB selection power to sponsors, streamlining study timelines and reducing administrative redundancies.
  • Sponsors can leverage the sIRB mandate to reassess trial site performance using standardized metrics like study startup time and enrollment diversity.
  • Efficient sites typically disentangle local administrative reviews from IRB processes, accept standard consent language, and integrate their systems with the sIRB's technology.
  • The sIRB mandate offers sponsors increased transparency into institutional processes, enabling them to optimize clinical trial efficiency across their portfolios.

Medicaid Coverage Shows Promise in Improving Cardiovascular Health Outcomes for Specific Subpopulations

  • A new study reveals that Medicaid coverage significantly reduces systolic blood pressure and glycated haemoglobin (HbA1c) levels in specific adult groups.
  • Machine learning techniques were employed to understand heterogeneous treatment effects, aligning with personalized medicine and targeted health interventions.
  • The study underscores the potential of Medicaid coverage to improve cardiovascular health for specific subpopulations, informing more equitable and effective health policies.
  • Further research is needed to validate these results across diverse populations and to determine the longer-term effects on cardiovascular health.

InStatin to Study Inhalable Statin for Asthma and COPD Treatment

  • InStatin will conduct a non-GLP discovery study with Mountain West Research to assess the pharmacokinetics of its statin inhalant solution.
  • The study aims to optimize the targeted delivery of the active pharmaceutical ingredient (API) to the lungs, enhancing efficacy and bioavailability.
  • The research findings will guide the development of InStatin's respiratory solutions, in preparation for Phase 1 human trials.
  • Therma Bright, which holds a 17% stake in InStatin, anticipates the study will validate the potential of innovative lung delivery systems.

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