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Nemluvio Shows Sustained Long-Term Efficacy in Atopic Dermatitis with Two-Year Extension Data

Monoclonal AntibodyDrug Approval
  • New two-year data from the ARCADIA long-term extension study demonstrate that Nemluvio (nemolizumab) maintains sustained and increased improvements in itch, skin lesions, sleep, and quality of life in patients with moderate-to-severe atopic dermatitis.
  • At week 104, more than 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), with approximately 85% achieving at least four-point improvement in itch scores.
  • The study reinforces Nemluvio's rapid onset of action at week 4 and demonstrates a consistent safety profile with no new safety signals identified during prolonged treatment up to two years.

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943CompletedPhase 3
Galderma R&D
Posted 6/27/2019

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

NCT03989206Active, Not RecruitingPhase 3
Galderma R&D
Posted 12/30/2019

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03989349CompletedPhase 3
Galderma R&D
Posted 6/30/2019

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04204616Active, Not RecruitingPhase 3
Galderma R&D
Posted 1/11/2021

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Upstream Bio Presents Data Showing Verekitug's Superior Potency Through TSLP Receptor Targeting at EAACI Congress

Monoclonal Antibody
  • Upstream Bio presented pharmacology modeling data at the EAACI Congress demonstrating verekitug's greater potency compared to tezepelumab through TSLP receptor targeting rather than ligand targeting.
  • The modeling data showed complete and sustained inhibition of the TSLP/TSLPR complex with verekitug across various doses, potentially leading to greater reduction in lung inflammation biomarkers.
  • Verekitug is the only monoclonal antibody currently in clinical development targeting the TSLP receptor and is being evaluated in Phase 2 trials for severe asthma, CRSwNP, and COPD.
  • The company expects top-line Phase 2 data in CRSwNP in Q3 2025 and severe asthma data in the first half of 2026.

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants with Chronic Rhinosinusitis with Nasal Polyps on a Background of Nasal Corticosteroids (VIBRANT)

2023-508231-31-00Active, Not RecruitingPhase 2
Upstream Bio Inc.

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

NCT06196879Active, Not RecruitingPhase 2
Upstream Bio Inc.
Posted 2/27/2024

A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

NCT06981078RecruitingPhase 2
Upstream Bio Inc.
Posted 7/2/2025

Scinai Immunotherapeutics Surges 104% Following Italian Regulatory Clearance for Pincell Acquisition

Monoclonal AntibodyOrphan DrugRare Disease
  • Scinai Immunotherapeutics shares soared 104% to $5.15 after receiving Italian government clearance under Golden Power regulation to potentially acquire 100% of Italian biotech Pincell S.r.l.
  • The acquisition would add PC111, a monoclonal antibody targeting the Fas/FasL pathway for severe skin conditions including Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis, which has received Orphan Drug Designation from the European Medicines Agency.
  • While the regulatory approval removes a major hurdle, the deal remains contingent on additional conditions including a €12 million grant decision expected by mid-July to early August 2025.
  • The move represents a significant expansion opportunity for Scinai, which operates dual business units in inflammation/immunology drug development and contract manufacturing services.

Biocytogen Secures Japan Patent for RenMab Platform, Strengthening Global IP Portfolio for Fully Human Antibody Discovery

Monoclonal AntibodyGene Editing
  • Biocytogen Pharmaceuticals has received a Japan Patent Office invention patent for its RenMab fully human antibody mouse platform technology, marking a significant milestone in global intellectual property expansion.
  • The RenMab platform uses proprietary SUPCE technology to replace murine immunoglobulin genes with human counterparts, enabling generation of fully human antibodies without additional humanization steps.
  • The company has established licensing agreements with over 20 companies including Merck KGaA, Janssen/Johnson & Johnson, and BeiGene, generating over 1,000,000 fully human antibody sequences against more than 1,000 therapeutic targets.
  • Biocytogen's RenMice platform has secured patent grants in nearly 10 countries with nearly 40 patent applications under examination across 15 countries and regions.

Mediar Therapeutics Initiates Phase 2 Trial of First-in-Class Anti-WISP1 Antibody for Idiopathic Pulmonary Fibrosis

Monoclonal AntibodyRare Disease
  • Mediar Therapeutics has dosed the first patient in its Phase 2 WISPer trial evaluating MTX-463, a first-in-class anti-WISP1 antibody for idiopathic pulmonary fibrosis treatment.
  • The randomized, double-blind, placebo-controlled study will measure changes in forced vital capacity at 24 weeks as its primary endpoint in IPF patients.
  • MTX-463 targets the myofibroblast, the key pathogenic cell driving fibrosis progression, representing a novel therapeutic approach for this devastating disease.
  • The company has entered a global licensing agreement with Eli Lilly to advance MTX-463 through the Phase 2 trial, while independently developing two additional fibrosis programs.

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06967805RecruitingPhase 2
Mediar Therapeutics
Posted 5/5/2025

Kiniksa Pharmaceuticals Advances KPL-387 Phase 2/3 Trial for Recurrent Pericarditis

Monoclonal Antibody
  • Kiniksa Pharmaceuticals announced the trial design for its Phase 2/3 clinical study of KPL-387, a monoclonal antibody targeting IL-1R1, in recurrent pericarditis patients.
  • The trial will enroll up to 165 participants across dose-focusing and pivotal portions, with initiation planned for mid-2025 and Phase 2 data expected in the second half of 2026.
  • KPL-387 offers a potential monthly subcutaneous dosing profile, which could expand treatment options for recurrent pericarditis patients currently facing limited therapeutic alternatives.

Rakuten Medical Secures AMED Funding for Novel PD-L1 Photoimmunotherapy RM-0256

Monoclonal AntibodyOrphan Drug
  • Rakuten Medical's RM-0256, an anti-PD-L1 antibody conjugated with light-activatable dye IR700, has been selected for funding by Japan's AMED under its orphan drug support program.
  • The novel photoimmunotherapy demonstrates a triple mechanism of action in preclinical studies, targeting PD-L1-expressing tumor cells while activating anti-tumor immunity and providing checkpoint blockade.
  • The therapy addresses an urgent medical need for patients with unresectable, advanced, or recurrent malignant epithelial tumors who develop resistance to current treatments.
  • With approximately 22,000 individuals affected by malignant epithelial tumors annually in Japan, RM-0256 represents a potential breakthrough for multiple solid tumor types including melanoma, breast, and urologic cancers.

Zigakibart Shows Sustained 60% Proteinuria Reduction in 100-Week IgA Nephropathy Study

Monoclonal Antibody
  • Zigakibart, an investigational anti-APRIL monoclonal antibody, demonstrated sustained efficacy with 60% proteinuria reduction from baseline at 100 weeks in IgA nephropathy patients.
  • Over half of patients (55%) achieved proteinuria below 500 mg/24h, with 31% reaching deeper remission below 300 mg/24h, while kidney function remained stable across all patient subgroups.
  • The treatment showed a reassuring safety profile with mostly mild to moderate adverse events and no treatment-related serious infections or discontinuations throughout the study period.
  • These represent the longest duration of kidney function stabilization reported for an anti-APRIL agent in IgA nephropathy, supporting zigakibart's potential as a disease-modifying therapy.

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

NCT05174221Active, Not RecruitingPhase 1
Takeda
Posted 11/9/2022

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

NCT03945318Active, Not RecruitingPhase 1
Novartis Pharmaceuticals
Posted 4/8/2019

A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/6/2023

Biocytogen and Nanjing Chia Tai Tianqing Receive IND Approval for Second-Generation Anti-IGF-1R Antibody NTB003 in Thyroid Eye Disease

Monoclonal Antibody
  • Biocytogen and Nanjing Chia Tai Tianqing received IND approval from China's NMPA for NTB003, a second-generation fully human anti-IGF-1R monoclonal antibody targeting Thyroid Eye Disease.
  • NTB003 demonstrates enhanced molecular affinity, improved druggability, and extended half-life compared to first-generation anti-IGF-1R therapeutics, with potent signal-blocking activity in vitro studies.
  • Clinical studies of anti-IGF-1R biologics have shown rapid therapeutic response and favorable outcomes in reducing proptosis and diplopia while improving quality of life in TED patients.
  • Nanjing Chia Tai Tianqing will lead clinical development and commercialization in China, while Biocytogen handles global out-licensing outside China.

Chinese Drug Combination Outperforms Keytruda in Advanced Lung Cancer Trial

Monoclonal Antibody
  • A Chinese-developed drug combination of Benmelstobart and Anlotinib demonstrated superior efficacy over pembrolizumab (Keytruda) in treating PD-L1-positive advanced non-small cell lung cancer patients.
  • The combination therapy increased median progression-free survival by 3.9 months to 11 months total, with a 30% reduction in disease progression and death risk compared to the current standard treatment.
  • Results from the Phase III CAMPASS study involving over 500 patients were presented at the American Society of Clinical Oncology annual meeting as a Late-Breaking Abstract.
  • The achievement marks a potential shift from Chinese pharmaceutical companies being followers to leaders in international cancer treatment development.

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