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Bluejay Therapeutics Initiates Phase 3 AZURE-2 Trial Comparing Brelovitug to Hepcludex for Chronic Hepatitis D

Monoclonal AntibodyOrphan Drug
  • Bluejay Therapeutics has enrolled the first patient in its AZURE-2 phase 3 trial, evaluating brelovitug monotherapy against Hepcludex for chronic hepatitis D treatment.
  • The randomized controlled study will assess a composite primary endpoint of undetectable hepatitis D virus RNA and normalized ALT levels at week 48.
  • Chronic hepatitis D affects approximately 7 million people globally and represents the most severe form of viral hepatitis with limited treatment options.
  • Brelovitug, which received FDA Breakthrough Therapy designation in January 2025, is a monoclonal antibody targeting surface antigens on both hepatitis D and B viruses.

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

NCT06907290RecruitingPhase 2
Bluejay Therapeutics, Inc.
Posted 3/25/2025

AL-S Pharma Reports Positive Phase 2 Results for AP-101 in ALS Treatment

Monoclonal AntibodyOrphan Drug
  • AL-S Pharma announced positive topline results from its Phase 2 study of AP-101, a first-in-class monoclonal antibody targeting misfolded SOD1 protein in amyotrophic lateral sclerosis patients.
  • The multicenter, randomized, double-blind, placebo-controlled study met its primary safety and tolerability endpoint in both sporadic ALS (N=52) and mutant SOD1-ALS (N=21) patients over 12 months of treatment.
  • Clinically meaningful changes in exploratory outcome measures related to survival and non-invasive ventilation were observed, along with stabilization of clinical disease-staging and neurofilament biomarkers.
  • This represents the first Phase 2 study to assess a SOD1-targeted therapeutic in both sporadic ALS and genetically determined SOD1-ALS patients, supporting the hypothesis that misfolded SOD1 protein plays a broader role in ALS pathogenesis.

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)

NCT05039099CompletedPhase 2
AL-S Pharma
Posted 9/2/2021

Walden Biosciences Engages Former FDA Director to Advance WAL0921 Phase 2 Trial in Rare Kidney Diseases

Monoclonal AntibodyRare Disease
  • Walden Biosciences has engaged Norman Stockbridge, M.D., Ph.D., former FDA Director of Division of Cardiology and Nephrology, as a regulatory advisor for its rare kidney disease pipeline.
  • The company partnered with NephCure, a nonprofit patient advocacy organization, to enhance patient recruitment for its ongoing Phase 2 basket study of WAL0921.
  • WAL0921 is a first-in-class humanized monoclonal antibody targeting suPAR to treat rare chronic kidney diseases, with interim data expected in late 2025 and early 2026.
  • The Phase 2 study will enroll up to 96 subjects across multiple rare kidney disease cohorts, including FSGS, IgAN, and primary membranous nephropathy.

Immunovant's Batoclimab Shows Sustained Remission in Graves' Disease Patients Six Months After Treatment

Monoclonal Antibody
  • Immunovant's batoclimab demonstrated sustained efficacy in uncontrolled Graves' disease patients, with 80% maintaining normal thyroid function six months after completing treatment.
  • Of the responding patients, 50% achieved complete remission without anti-thyroid drugs, suggesting potential disease-modifying effects of FcRn blockade therapy.
  • Two registrational trials for IMVT-1402 are currently enrolling patients, with topline results expected in 2027 for this potentially first-in-class treatment approach.
  • The proof-of-concept study results will be presented at the 2025 American Thyroid Association meeting, marking a potential paradigm shift in Graves' disease treatment.

IgGenix Completes Enrollment for First-in-Human Trial of Novel Peanut Allergy Antibody Therapy

Monoclonal Antibody
  • IgGenix has completed enrollment for its Phase 1 ACCELERATE Peanut study of IGNX001, a first-in-class monoclonal antibody therapy for peanut allergy prevention.
  • The randomized, double-blind, placebo-controlled study represents the world's first clinical trial of a novel antibody therapeutic in peanut allergic individuals using the proprietary SEQ SIFTER™ platform.
  • IGNX001 is designed to prevent allergic reactions by blocking peanut allergen binding to IgE antibodies, potentially offering a fast-acting treatment option.
  • Topline safety and efficacy data from this pivotal first-in-human study are expected to be released in the coming months.

Zenas BioPharma Secures $300 Million Royalty Deal with Royalty Pharma for Obexelimab Development

Monoclonal Antibody
  • Zenas BioPharma and Royalty Pharma announced a $300 million funding partnership to advance obexelimab development for IgG4-Related Disease and other autoimmune conditions.
  • The deal includes an initial $75 million payment with additional milestone-based payments tied to Phase 3 INDIGO trial results and FDA approvals for IgG4-RD and SLE.
  • Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb that inhibits B cell function without depleting cells, representing a novel approach to autoimmune disease treatment.
  • The funding supports potential commercial launch in the first half of 2027 and extends Zenas' cash runway through Q1 2027, with key trial readouts expected by year-end 2025.

Citryll Initiates Phase IIa Trial of First-in-Class NET-Targeting Antibody CIT-013 for Rheumatoid Arthritis

Monoclonal Antibody
  • Citryll has dosed the first patient in its Phase IIa "Citydream" trial evaluating CIT-013, a first-in-class monoclonal antibody targeting Neutrophil Extracellular Traps (NETs) in moderately active rheumatoid arthritis.
  • The randomized, double-blind, placebo-controlled study will enroll 88 patients across multiple European sites for a 6-week treatment period followed by an open-label extension phase.
  • CIT-013 represents a novel therapeutic approach with dual mechanism of action that enhances clearance of existing NETs and inhibits formation of new NETs, potentially offering disease-modifying treatment.
  • The trial follows successful completion of a Phase 1 study and an €85 million Series B fundraise, with an additional Phase IIa trial planned for hidradenitis suppurativa later this year.

FDA Grants First-Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

Monoclonal Antibody
  • Professor Sarfaraz K. Niazi has secured the first-ever FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars, fundamentally redefining biological drug development and approval processes.
  • The breakthrough decision is expected to reduce biosimilar development costs by over 90% and accelerate approval timelines by more than 70%, making biological medicines more accessible to patients worldwide.
  • Niazi's Stelara biosimilar application will be the first filed with the FDA without requiring clinical testing, establishing a precedent-setting regulatory pathway.
  • The regulatory shift empowers smaller companies to enter the biosimilar market and aligns FDA practices with the European Medicines Agency and UK's MHRA approaches.

Searle Secures Pakistani Regulatory Approval for Denosumab Biosimilar Injections

Monoclonal AntibodyDrug ApprovalOncology
  • The Searle Company Limited has obtained registration from Pakistan's Drug Regulatory Authority for Denosumab biosimilar injections in 60mg and 120mg doses.
  • The company holds marketing and sales rights in Pakistan under a licensing agreement with Chinese manufacturer Mabwell Pharmaceuticals.
  • The 60mg formulation targets osteoporosis management while the 120mg dose is intended for oncology care applications.
  • Searle is preparing for commercial launch, marking a significant expansion of its product portfolio in Pakistan's pharmaceutical market.

NICE Approves Guselkumab for Moderate to Severe Ulcerative Colitis and Crohn's Disease

Drug ApprovalMonoclonal Antibody
  • NICE has recommended guselkumab (Tremfya) as a treatment option for adults with moderately to severely active ulcerative colitis and Crohn's disease when conventional treatments and TNF-alpha inhibitors have failed.
  • The IL-23 inhibitor demonstrated effectiveness comparable to existing biologics mirikizumab and vedolizumab through indirect comparisons, with similar or lower costs.
  • Guselkumab will be available through the NHS in England within 30 days of final guidance publication, expanding treatment options for patients with refractory inflammatory bowel disease.

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