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Spinogenix's SPG302 Enters Phase 2 Trial as Novel Schizophrenia Treatment

  • Spinogenix has initiated a Phase 2 clinical trial to evaluate SPG302, a novel synaptic regenerative therapy, for the treatment of schizophrenia.
  • SPG302 aims to restore glutamatergic synapses, addressing a key feature of schizophrenia pathogenesis linked to positive, negative, and cognitive symptoms.
  • The Phase 2 trial is a randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of once-daily oral SPG302 in adults.
  • SPG302 has already received FDA Orphan Drug Designation for ALS and is under evaluation for Alzheimer's disease, showcasing its potential in neurodegenerative conditions.

Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

NCT06427668Active, Not RecruitingPhase 2
Spinogenix
Posted 7/29/2024

Study of SPG302 in Healthy Volunteers and ALS Participants

NCT05882695CompletedPhase 1
Spinogenix
Posted 7/3/2023

Study of SPG302 in Adults With Schizophrenia

NCT06442462RecruitingPhase 2
Spinogenix
Posted 8/1/2024

Shield Therapeutics' Oral Iron Suspension Shows Promise in Pediatric Trial

  • Shield Therapeutics' FORTIS/ST10-01-305 trial met all primary endpoints, demonstrating a clinically relevant increase in hemoglobin (Hb) levels over 12 weeks in children with iron deficiency.
  • In children aged 2-17, the mean Hb increase was 1.25 g/dL, while infants showed an increase of 1.77 g/dL, compared to 1.15 g/dL in the ferrous sulphate group.
  • No patients in the ferric maltol group discontinued the study due to treatment-related adverse events, highlighting the safety and tolerability of the oral liquid suspension.
  • Shield Therapeutics plans to submit regulatory applications to the FDA and EMA in the first half of 2025 for a pediatric indication, with potential for a €1m milestone payment from Norgine.

FDA Considers Narrowing PD-1 Inhibitor Label for Gastric Cancer Based on PD-L1 Expression

  • The FDA is considering limiting the use of PD-1 inhibitors like Keytruda and Opdivo in gastric adenocarcinoma based on PD-L1 expression levels.
  • FDA reviewers suggest that patients with low PD-L1 expression may not benefit substantially from these therapies, potentially exposing them to unnecessary risks.
  • Merck and BMS argue for maintaining the current broad label, while BeiGene supports consistent labeling across PD-1 agents, especially for patients with PD-L1 levels of at least 5%.
  • An FDA advisory committee meeting will discuss these concerns and the potential need for biomarker-driven treatment eligibility.

Keytruda-Favezelimab Combo Fails to Improve Survival in Colorectal Cancer Trial

• Merck's Keytruda combined with favezelimab did not significantly improve overall survival in metastatic colorectal cancer patients in the Phase III KEYFORM-007 trial. • The trial enrolled over 440 patients with microsatellite stable metastatic colorectal cancer who had previously undergone standard treatments and were PD-L1 positive. • Despite the setback, Merck plans to continue evaluating Keytruda-based combinations and novel candidates for colorectal cancer, according to Catherine Pietanza. • This failure highlights the difficulty in developing effective treatments for MSS colorectal cancer, following a similar discontinuation by Bristol Myers Squibb in December 2023.

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

NCT05064059CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/10/2021

Golfers Against Cancer Funds CU Cancer Center Research on Pediatric CAR T-cell Therapy

  • Golfers Against Cancer Denver funds three CU Cancer Center research projects focused on enhancing CAR T-cell therapy for pediatric cancers.
  • Researchers will investigate novel approaches, including particle backpacks for targeted drug delivery and logic-gated CAR-T cells, to improve treatment efficacy.
  • Studies target resistance mechanisms in B-cell acute lymphoblastic leukemia and aim to translate findings into impactful therapies for children with aggressive cancers.
  • The grants provide crucial seed funding for high-risk research, enabling investigators to gather preliminary data needed for larger NIH and Department of Defense grants.

Daehan Nupharm Launches Enpiflu Premix, a Single-Dose Influenza Treatment

  • Daehan Nupharm has launched Enpiflu Premix, a premixed peramivir hydrate injection, offering a single-dose intravenous treatment for influenza A and B in adults and children.
  • Clinical trials across Korea, Japan, and Taiwan involving 1,091 adult patients demonstrated peramivir's effectiveness is comparable to oseltamivir in reducing symptom duration.
  • Enpiflu Premix's ready-to-use formulation enhances safety and efficiency by eliminating compounding, reducing preparation time, and minimizing contamination risks.
  • The peramivir market has grown significantly, reaching 36.1 billion won in 2023, driven by increased influenza cases since the COVID-19 pandemic.

Condoliase (SI-6603) Shows Promise in Phase 3 Trials for Lumbar Disc Herniation

  • SI-6603, an investigational treatment, significantly improved leg pain compared to sham in U.S. and placebo in Japan at Week 13 in Phase 3 trials.
  • The studies involved intradiscal injections of SI-6603 and demonstrated statistically significant changes from baseline in worst leg pain.
  • Common adverse events included spinal MRI abnormalities and back pain, with no treatment-related serious adverse events reported in the U.S. study.
  • These findings support SI-6603's potential as a therapeutic option for radicular leg pain associated with lumbar disc herniation.

SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

NCT03607838CompletedPhase 3
Seikagaku Corporation
Posted 11/7/2018

FDA Approves Heron Therapeutics' Zynrelef Vial Access Needle for Postoperative Pain Management

  • The FDA has approved Heron Therapeutics' Prior Approval Supplement Application for the Zynrelef Vial Access Needle (VAN).
  • The VAN simplifies aseptic preparation and significantly reduces Zynrelef's withdrawal time to 20-45 seconds.
  • Expected to launch in Q4 2024, the VAN aims to enhance safe use, increase adoption, and improve the preparation process of Zynrelef.
  • Zynrelef is a dual-acting local anesthetic combining bupivacaine and meloxicam, designed to reduce postoperative pain for up to 72 hours.

DURECT's Larsucosterol Shows Promise in Alcohol-Associated Hepatitis Treatment

  • DURECT Corporation's larsucosterol demonstrates potential in treating alcohol-associated hepatitis (AH) by reducing mortality rates in U.S. patients.
  • A Phase 3 trial, agreed upon with the FDA, will assess larsucosterol's efficacy with a 90-day survival primary endpoint, aiming for topline data within two years.
  • Larsucosterol targets DNA methyltransferases, epigenetic enzymes linked to hypermethylation in AH, offering a novel approach to managing the condition.
  • Data from the AHFIRM Phase 2b trial supports the Phase 3 design, showing significant mortality reduction with larsucosterol in U.S. patients.

A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

NCT04563026CompletedPhase 2
Durect
Posted 1/22/2021

New Research Advances Understanding of Multiple Myeloma Precursor Diseases MGUS and SMM

  • Recent genomic studies reveal that multiple myeloma's genome develops over 30 years, with precursor conditions MGUS and SMM showing distinct molecular signatures and progression risks.
  • Breakthrough research identifies key genomic aberrations like MYC and MAPK mutations that predict progression from MGUS and SMM to multiple myeloma, enabling better risk stratification.
  • Clinical trials demonstrate promising results with lenalidomide treatment in high-risk SMM patients, showing 82% reduction in end organ damage and 70% decrease in mortality risk.

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

NCT04270409Active, Not RecruitingPhase 3
Sanofi
Posted 6/16/2020

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/7/2017

Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

NCT03937635RecruitingPhase 3
ECOG-ACRIN Cancer Research Group
Posted 9/16/2019

QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

NCT00480363CompletedPhase 3
PETHEMA Foundation
Posted 5/1/2007

A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM)

NCT03815279Enrolling by InvitationPhase 2
Landspitali University Hospital
Posted 6/24/2019

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