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Clinical Trial News

FDA Expands Indications for Cerapedics' i-FACTOR Bone Graft in Cervical Spinal Fusion

  • The FDA has approved expanded indications for Cerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft, enhancing its utility in spinal fusion procedures.
  • i-FACTOR is now approved for single-level ACDF with an allograft bone ring or with PEEK or titanium interbody devices, alongside anterior plate fixation.
  • This expansion underscores Cerapedics' commitment to evidence-based bone grafting, providing surgeons with a proven and safe option for spinal fusion.
  • Backed by Level 1 clinical data, i-FACTOR is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, ensuring a precise bone-building mechanism.

Clene to Meet with FDA to Discuss Accelerated Approval for CNM-Au8 in ALS

  • Clene will meet with the FDA to discuss accelerated approval of CNM-Au8 for amyotrophic lateral sclerosis (ALS).
  • The meeting will involve senior FDA leadership and experts to discuss ALS biomarkers, clinical endpoints, and survival data related to CNM-Au8.
  • CNM-Au8, a gold nanoparticle suspension, aims to support nerve cell energy needs and has shown potential in slowing ALS progression.
  • Clene is seeking accelerated approval based on data demonstrating CNM-Au8 significantly lowers neurofilament light chain (NfL) levels, a biomarker of nerve cell damage.

HEALEY ALS Platform Trial - Master Protocol

NCT04297683Active, Not RecruitingPhase 2
Merit E. Cudkowicz, MD
Posted 7/14/2020

Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

NCT04098406CompletedPhase 2
Clene Nanomedicine
Posted 12/19/2019

Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease

  • Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
  • The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
  • Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
  • Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

NCT05738486Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 2/28/2023

Re:Cognition Health USA Achieves GCSA Clinical Trial Site Certification

  • Re:Cognition Health USA has earned GCSA Clinical Trial Site Certification, marking them as the first to achieve this in both the US and Europe.
  • The GCSA certification confirms the site's adherence to high-quality global best practices, assessed independently by the IAOCR.
  • This certification covers critical areas like feasibility, study start-up, patient engagement, and workforce process quality.
  • The GCSA quality mark assures sponsors, CROs, staff, and patients of the site's reliability in delivering clinical trials.

Aviceda Therapeutics Completes Enrollment in Phase 2b SIGLEC Study of AVD-104 for Geographic Atrophy

  • Aviceda Therapeutics has completed enrollment for its Phase 2b SIGLEC study evaluating AVD-104 for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
  • The study compares AVD-104, an intravitreal glycomimetic nanoparticle, to avacincaptad pegol (IZERVAY) in approximately 300 patients across multiple centers.
  • Phase 2a results showed AVD-104 was well-tolerated and led to reduced GA lesion progression and improved visual acuity compared to untreated eyes.
  • Topline 12-month data from the Phase 2b SIGLEC study, assessing the growth rate of GA area, is expected in the second half of 2025.

Metsera's MET-097 Shows Promising Weight Loss Results in Phase 1 Trial

  • Metsera's MET-097, a long-acting GLP-1 receptor agonist, demonstrated significant weight loss in a Phase 1 trial, supporting potential once-monthly dosing.
  • Participants receiving a 1.2 mg dose of MET-097 experienced a 7.5% reduction in body weight at day 36, with continued weight loss of 8.1% at day 57.
  • The trial reported a favorable safety profile with mostly mild, dose-related gastrointestinal adverse events and no treatment-related discontinuations.
  • Metsera plans to initiate a Phase 2b trial in Q4 2024 to further evaluate MET-097 for obesity and metabolic diseases.

Nevro's AI-Powered Spinal Cord Stimulation System, HFX iQ with AdaptivAI, Receives FDA Approval

  • Nevro's HFX iQ with AdaptivAI, an AI-driven spinal cord stimulation system, has gained FDA approval for chronic pain management.
  • HFX AdaptivAI leverages AI and patient data to personalize pain relief, optimizing therapy and potentially reducing device charging frequency.
  • The system offers real-time insights and remote monitoring, enhancing patient-clinician interactions and enabling proactive pain management.
  • Nevro plans a full market release in the U.S. in Q4 2024, expanding access to this innovative pain relief technology.

Ainos to Initiate Phase 3 Trial of Low-Dose Interferon-alpha for Sjögren's Syndrome

  • Ainos is set to begin a Phase 3 clinical trial in Taiwan in December 2024 to assess Veldona, a low-dose interferon-alpha formulation, for primary Sjögren's disease.
  • The trial aims to enroll 24 patients and will evaluate Veldona's efficacy in improving saliva secretion and reducing dryness symptoms over 24-48 weeks.
  • Previous Phase 3 trials in the U.S. showed Veldona improved saliva production and eased dryness symptoms without significant side effects.
  • The study's primary endpoint is to evaluate the improvement of saliva secretion and dryness symptoms, with trial completion projected by January 2026.

NeuroSense's PrimeC Demonstrates Efficacy in ALS, Pursues Early Approval in Canada

  • NeuroSense Therapeutics' PrimeC showed a 36% reduction in ALS disease progression and a 43% improvement in survival rates in clinical trials.
  • The company is pursuing early commercialization approval in Canada based on Phase 2b trial results and Health Canada's Notice of Compliance with Conditions policy.
  • PrimeC, a novel formulation of ciprofloxacin and celecoxib, has received a key U.S. patent extending its protection to 2042.
  • Two abstracts featuring PrimeC data will be presented at the 2024 Annual NEALS Consortium Meeting, highlighting clinical outcomes and biomarker analysis.

A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

NCT05357950Active, Not RecruitingPhase 2
NeuroSense Therapeutics Ltd.
Posted 5/31/2022

FDA Grants Fast Track Designation to ALXN2220 for ATTR Amyloidosis with Cardiomyopathy

  • The FDA has granted Fast Track designation to ALXN2220, a novel depleter monoclonal antibody, for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
  • ALXN2220 aims to address the unmet need in ATTR-CM by removing amyloid deposits and potentially restoring organ function.
  • The designation allows for more frequent interactions with the FDA and potential accelerated review and approval pathways.
  • ALXN2220 is currently being evaluated in the Phase 3 DepleTTR-CM trial to assess its efficacy as an add-on treatment for ATTR-CM.

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