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Livzon's Dual-Target IL-17A/F Antibody LZM012 Outperforms Secukinumab in Phase III Psoriasis Trial

Monoclonal Antibody
  • Livzon Pharmaceutical's LZM012, the first domestic dual-target IL-17A/F monoclonal antibody, achieved superior efficacy compared to Secukinumab in a Phase III trial for moderate to severe plaque psoriasis.
  • The study demonstrated LZM012's 49.5% PASI 100 response rate at week 12 versus 40.2% for Secukinumab, with faster onset of action and sustained benefits through 52 weeks.
  • LZM012 showed good overall safety profile with adverse event rates comparable to the control group, and Livzon has submitted pre-market communication to China's NMPA for regulatory approval.

Sun Pharma's ILUMYA Achieves Primary Endpoints in Two Phase 3 Psoriatic Arthritis Trials

Monoclonal Antibody
  • Sun Pharmaceutical Industries announced that tildrakizumab (ILUMYA) 100 mg successfully met primary endpoints in two Phase 3 clinical studies for active psoriatic arthritis treatment.
  • Both INSPIRE-1 and INSPIRE-2 trials demonstrated significantly higher ACR20 response rates at week 24 compared to placebo (p < 0.05).
  • The 24-week studies showed that ILUMYA treatment resulted in greater improvements in psoriatic arthritis signs and symptoms versus placebo.
  • These positive results reinforce ILUMYA's therapeutic potential as a treatment option for patients with active psoriatic arthritis.

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

NCT04314531Active, Not RecruitingPhase 3
Sun Pharmaceutical Industries Limited
Posted 7/1/2020

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

NCT04314544Active, Not RecruitingPhase 3
Sun Pharmaceutical Industries Limited
Posted 7/1/2020

Roche's Astegolimab Shows Mixed Results in COPD Trials, Phase IIb Study Meets Primary Endpoint

Monoclonal Antibody
  • Roche's pivotal Phase IIb ALIENTO study met its primary endpoint, showing astegolimab reduced annualized exacerbation rate by 15.4% in COPD patients at 52 weeks.
  • The Phase III ARNASA study failed to meet its primary endpoint despite demonstrating a numerical 14.5% reduction in exacerbation rate.
  • Both studies enrolled broad COPD populations including former and current smokers regardless of blood eosinophil count, representing the first trials in an "all-comers" COPD population.
  • The safety profile remained consistent with previous data with no new safety signals identified across both trials.

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05595642RecruitingPhase 3
Hoffmann-La Roche
Posted 12/29/2022

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05037929CompletedPhase 2
Genentech, Inc.
Posted 10/5/2021

Delhi High Court Grants Interim Injunction Against Zydus Biosimilar to Protect Nivolumab Patent Rights

Monoclonal Antibody
  • The Delhi High Court granted an interim injunction restraining Zydus Lifesciences from manufacturing or launching its biosimilar ZRC-3276, which references Nivolumab (Opdivo) as the reference product.
  • The court found prima facie evidence of patent infringement for Indian Patent No. IN 340060 covering the anti-PD-1 monoclonal antibody Nivolumab, used in cancer immunotherapy.
  • E.R. Squibb and Sons successfully demonstrated that prior art documents cited by Zydus did not disclose the specific amino acid sequences claimed in their patent.
  • The injunction remains in effect until the patent expires in May 2026 or final adjudication of the suit, with Zydus required to disclose quantities of any manufactured biosimilar product.

Hengrui Medicine Advances Cancer Pipeline with Breakthrough Therapy Designations and Clinical Trial Approvals

Orphan DrugOncologyMonoclonal Antibody
  • Jiangsu Hengrui Medicine secured inclusion of two products on China's proposed breakthrough therapy list, highlighting their potential to address unmet medical needs in gastric cancer treatment.
  • The company received US FDA orphan drug designation for trastuzumab for injection, providing development incentives including tax credits and market exclusivity for this gastric cancer therapy.
  • Hengrui obtained clinical trial approval for three oncology drugs, enabling advancement of its cancer treatment research and potential commercialization of innovative therapies.
  • The pharmaceutical company partnered with GlaxoSmithKline to develop up to 12 innovative medicines across respiratory, immunology, inflammation, and oncology therapeutic areas.

Eledon Pharmaceuticals to Present Updated Phase 1b Kidney Transplant Data for Tegoprubart at World Transplant Congress 2025

Monoclonal Antibody
  • Eledon Pharmaceuticals will present updated clinical data from approximately 30 kidney transplant recipients in their ongoing Phase 1b study of tegoprubart at the World Transplant Congress in San Francisco.
  • The anti-CD40L antibody tegoprubart is being developed for kidney transplant rejection prevention and will be featured in an oral presentation by Dr. John Gill from the University of British Columbia.
  • Additional preclinical data will showcase tegoprubart's potential in liver transplantation using non-human primate models, indicating expanded therapeutic applications beyond kidney transplantation.
  • The company will sponsor a satellite symposium exploring long-term transplant success metrics, positioning tegoprubart in the context of lasting graft function rather than just short-term rejection prevention.

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

NCT05983770Active, Not RecruitingPhase 2
Eledon Pharmaceuticals
Posted 8/30/2023

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

NCT06126380Unknown StatusPhase 2
Eledon Pharmaceuticals
Posted 10/25/2023

Acute Ischemic Stroke Pipeline Shows Promise with 25+ Therapies in Development and Recent Clinical Breakthroughs

FDA ApprovalMonoclonal Antibody
  • DelveInsight's 2025 analysis reveals over 20 key companies are developing 25+ acute ischemic stroke therapies across various clinical phases, representing significant advancement in stroke treatment research.
  • Recent clinical trials demonstrate promising results, including the ASSET-IT trial showing 65.9% excellent recovery rates with tirofiban combination therapy compared to 54.9% with placebo.
  • Multiple FDA designations have been granted, including Fast Track status for PP-007 and Orphan Drug Designation for CIRARA, accelerating development timelines for innovative stroke treatments.
  • The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and cell therapies, targeting various mechanisms from neuroprotection to thrombolysis enhancement.

PMZ-1620 (Sovateltide) in Acute Ischemic Stroke Patients

NCT04046484CompletedPhase 2
Pharmazz, Inc.
Posted 1/19/2018

Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke

NCT04047563CompletedPhase 3
Pharmazz, Inc.
Posted 11/10/2019

FDA Accepts Biosimilar Application for BAT2506, Proposed Golimumab Alternative

Monoclonal AntibodyDrug Approval
  • The FDA has accepted Bio-Thera Solutions' Biologics License Application for BAT2506, a proposed biosimilar to Simponi (golimumab), with a target review completion date of May 16, 2026.
  • The application seeks approval for all current Simponi indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, with interchangeability designation requested.
  • BAT2506 demonstrated similar efficacy, safety, and immunogenicity to reference golimumab in comprehensive Phase I and Phase III clinical studies.
  • Accord BioPharma will serve as the marketing authorization holder and commercialize the biosimilar in the United States if approved.

AstraZeneca's Anselamimab Fails Primary Endpoint in Phase III AL Amyloidosis Trial, Shows Promise in Patient Subgroup

Monoclonal AntibodyRare DiseaseOrphan Drug
  • AstraZeneca's CARES Phase III clinical programme evaluating anselamimab in patients with Mayo stages IIIa and IIIb light chain amyloidosis did not achieve statistical significance for the primary endpoint of time to all-cause mortality and cardiovascular hospitalizations.
  • Despite missing the primary endpoint in the overall population, anselamimab demonstrated highly clinically meaningful improvement in survival and cardiovascular hospitalization rates in a prespecified patient subgroup compared to placebo.
  • The investigational anti-fibril monoclonal antibody represents a potentially first-in-class approach to clearing amyloid deposits in AL amyloidosis, a rare and life-threatening disorder affecting an estimated 74,000 patients worldwide.
  • Anselamimab was well tolerated with balanced adverse events between treatment and placebo arms, and Alexion plans to share full results with global health authorities and present data at upcoming medical meetings.

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

NCT04304144CompletedPhase 2
Alexion Pharmaceuticals, Inc.
Posted 3/18/2020

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)

NCT04504825Active, Not RecruitingPhase 3
Alexion Pharmaceuticals, Inc.
Posted 2/2/2021

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)

NCT04512235Active, Not RecruitingPhase 3
Alexion Pharmaceuticals, Inc.
Posted 11/3/2020

McMaster Study Identifies Most Effective Treatments for Chronic Hives Through Comprehensive Meta-Analysis

Monoclonal Antibody
  • A McMaster University-led international study analyzed 93 randomized controlled trials involving over 11,000 participants to identify the most effective treatments for chronic hives.
  • Omalizumab and remibrutinib emerged as the most effective treatments for reducing hives, itch, and swelling with favorable safety profiles.
  • Dupilumab showed particular promise for reducing hives, while cyclosporine demonstrated effectiveness but carried higher risks of side effects including kidney toxicity.
  • The comprehensive network meta-analysis examined more than 40 treatment options and will inform new international clinical guidelines for chronic urticaria management.

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