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Clinical Trial News

AI Shows Promise and Limitations Across Multiple Cancer Care Applications

  • AI demonstrates significant potential in cancer diagnosis, with deep learning models achieving up to 94% accuracy in lung cancer prediction and substantially improving radiologist performance in image analysis.
  • Recent studies show AI language models reaching 85% accuracy on medical oncology exam questions, though concerns remain about potential clinical harm from incorrect responses.
  • AI applications are expanding into clinical trial design, patient recruitment, and treatment optimization, with ongoing trials evaluating AI platforms for immunotherapy and chemotherapy dose management.

CURATE.AI Optimized Modulation for Multiple Myeloma

NCT03759093RecruitingPhase 2
National University Hospital, Singapore
Posted 9/10/2023

Nivolumab and Pembrolizumab Dose Optimisation in Solid Tumours With CURATE.AI Platform and Sequential ctDNA Measurements

NCT05175235RecruitingPhase 1
National University Hospital, Singapore
Posted 8/19/2021

Relief Therapeutics Receives $2 Million Milestone Payment After FDA Approval of Arimoclomol

  • Relief Therapeutics will receive a $2 million milestone payment from SWK Funding LLC following the FDA approval of Zevra Therapeutics' arimoclomol.
  • The FDA approved arimoclomol (MIPLYFFA) for treating neurological manifestations of Niemann-Pick Disease Type C in patients aged 2 years and older.
  • This payment is part of a royalty monetization agreement where Relief received $5.75 million initially and could receive up to $5.25 million based on milestones.

Innate Pharma's IPH4502, a Nectin-4-Targeting ADC, Receives FDA IND Clearance for Phase 1 Solid Tumor Trial

  • Innate Pharma received FDA clearance for its IND application for IPH4502, an antibody-drug conjugate targeting Nectin-4 in solid tumors.
  • The Phase 1 trial will evaluate the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors expressing Nectin-4.
  • The open-label, multi-center study will include dose escalation and optimization phases to determine the appropriate dosage.
  • IPH4502 represents Innate Pharma's first ADC program to enter clinical trials, marking a significant milestone for the company.

Bimekizumab Gains FDA Approval for Single-Injection Delivery, Expanding Treatment Options

  • The FDA has approved a 320 mg single-injection option for bimekizumab (Bimzelx), offering a more convenient administration for patients with moderate to severe plaque psoriasis.
  • This approval is based on bioequivalence data comparing single 2 mL injections to two 1 mL injections, streamlining the treatment process for patients requiring a 320 mg maintenance dose.
  • Bimekizumab, a humanized monoclonal antibody, selectively targets IL-17A and IL-17F, providing a differentiated approach for managing plaque psoriasis and psoriatic arthritis.
  • The new single-injection option is expected to be available in the U.S. in Q1 2025, enhancing patient adherence and overall treatment experience.

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

NCT03928704CompletedPhase 3
UCB Biopharma SRL
Posted 4/25/2019

A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis

NCT02963506CompletedPhase 2
UCB Biopharma S.P.R.L.
Posted 10/1/2016

A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

NCT03895203CompletedPhase 3
UCB Biopharma SRL
Posted 4/3/2019

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

NCT03896581CompletedPhase 3
UCB Biopharma SRL
Posted 3/28/2019

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

NCT04436640Active, Not RecruitingPhase 3
UCB Biopharma SRL
Posted 6/16/2020

A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

NCT03355573CompletedPhase 2
UCB Biopharma SRL
Posted 11/28/2017

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

NCT03928743CompletedPhase 3
UCB Biopharma SRL
Posted 4/25/2019

Sinaptica Therapeutics' rTMS Shows Promise in Slowing Alzheimer's Progression in Phase 2 Trial

  • Sinaptica Therapeutics' Phase 2 trial of personalized rTMS therapy demonstrated a halt in disease progression for individuals with mild to moderate Alzheimer's disease over 24 weeks.
  • The rTMS treatment targets the precuneus region of the brain, aiming to activate neuroplasticity and strengthen neural connections within the default mode network.
  • Participants receiving active rTMS showed no decline on a standardized dementia scale, while the sham group declined by 1.3 points, suggesting potential cognitive benefits.
  • A larger Phase 3 trial is being planned to further evaluate the efficacy and safety of rTMS, including measurements of Alzheimer’s biomarkers.

PepGen's PGN-EDO51 Shows Promise in Duchenne Muscular Dystrophy Trial

  • PepGen anticipates releasing preliminary data from its Phase II CONNECT1-EDO51 trial of PGN-EDO51 in mid-2024, offering a potential treatment for Duchenne muscular dystrophy (DMD).
  • The CONNECT1-EDO51 trial assesses the safety, exon 51 skipping, and dystrophin protein production in male patients with DMD amenable to exon 51 skipping.
  • PGN-EDO51 utilizes PepGen's Enhanced Delivery Oligonucleotide (EDO) technology to target the genetic root cause of DMD, a muscle-wasting disease.
  • PepGen is also advancing PGN-EDODM1 for myotonic dystrophy type 1 (DM1), with Phase I trial data expected this year, alongside preclinical DMD programs.

FDA Accepts Resubmission of NDA for Rivoceranib and Camrelizumab in Unresectable Hepatocellular Carcinoma

  • The FDA has accepted the resubmitted NDA for rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.
  • The resubmission includes data from the Phase 3 CARES-310 study, which showed a median overall survival of 23.8 months with the combination.
  • The FDA has set a PDUFA target action date of March 20, 2025, for the rivoceranib and camrelizumab combination in uHCC.
  • The CARES-310 study demonstrated consistent efficacy across patient subgroups, suggesting the combination's potential benefit for a global uHCC population.

A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

NCT03764293CompletedPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 6/10/2019

Amplia Therapeutics' Narmafotinib Shows Promise in Pancreatic Cancer Trial, Triggering Expanded Enrollment

  • Amplia Therapeutics' Phase 2a trial of narmafotinib in advanced pancreatic cancer achieves a significant milestone with six confirmed partial responses.
  • The combination therapy of narmafotinib with gemcitabine and Abraxane® demonstrates sufficient activity to warrant continued enrollment in the ACCENT trial.
  • Recruitment will resume at trial sites in Australia and South Korea, aiming to complete enrollment of the remaining 24 patients by the end of Q1 2025.
  • Narmafotinib continues to be well-tolerated, with no significant safety concerns or dose reductions reported to date in the ongoing clinical trial.

Synergia Medical's NAO.VNS System Successfully Implanted in First-in-Human Epilepsy Study

  • Synergia Medical successfully implanted its NAO.VNS system in two patients with drug-resistant epilepsy as part of the AURORA study.
  • The first-in-human implantations occurred at Cliniques Universitaires Saint-Luc and UZ Gent, with both patients recovering fully and starting stimulation therapy.
  • The AURORA study will assess the safety of the NAO.VNS system over 24 months, with plans for a pivotal trial in Europe, the USA, and Canada.
  • NAO.VNS offers MRI compatibility, extended battery life, and enhanced cybersecurity through optoelectronic technology for personalized vagus nerve stimulation.

AERIFY-1/2 Trials: Evaluating Itepekimab for Moderate-to-Severe COPD in Former Smokers

The AERIFY-1 and AERIFY-2 phase 3 trials aim to assess the efficacy and safety of itepekimab, an anti-IL-33 monoclonal antibody, in former smokers with moderate-to-severe COPD. These randomized, double-blind, placebo-controlled studies will evaluate the impact of itepekimab on reducing exacerbations and improving lung function over 52 weeks.

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04751487Active, Not RecruitingPhase 3
Sanofi
Posted 2/12/2021

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04701983Active, Not RecruitingPhase 3
Sanofi
Posted 12/16/2020

Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

NCT03546907CompletedPhase 2
Sanofi
Posted 7/16/2018

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