BEL512 / Belenos Biosciences, Keymed Biosciences - LARVOL DELTA

Belenos Announces Positive Phase 1b Interim Asthma Results for BEL512, a Long-Acting TSLP/IL-13 Bispecific Antibody (Businesswire) - "BEL512 was generally well tolerated as of the interim data cutoff...Significant reductions in FeNO reductions were observed on Day 4 and FeNO remained significantly reduced throughout the assessment period, with many participants achieving normal FeNO levels regardless of their baseline. Significant reductions in BEC were observed by Day 36....Importantly, there was evident concordance between FeNO and BEC reductions, and also between improvements in FeNO and FEV1 among the BEL512-treated patients. These exploratory findings provide encouraging evidence that the rapid pharmacodynamic effects of BEL512 on airway inflammation are accompanied by improvements in lung function in patients with moderate asthma."

P1 data • Asthma • Immunology

BEL512 Respiratory Development Program (Businesswire) - "Belenos plans to initiate two global Phase 3 respiratory programs with BEL512 in 2027, beginning with a Phase 3 program in CRSwNP in the first half of 2027, followed by a Phase 3 asthma program in the second half of 2027. Belenos also plans to initiate a global Phase 3 program in chronic obstructive pulmonary disease (COPD) in 2028."

New P3 trial • Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-3) (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Beijing Keymed Biosciences Co., Ltd.

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of CM512, a Bispecific Antibody Targeting TSLP and IL-13, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial (EADV 2026) - No abstract available

Bispecific • Clinical • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • TSLP

A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis ?NEZHA-1? (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Beijing Keymed Biosciences Co., Ltd. | Trial primary completion date: Sep 2026 ➔ Apr 2026 | Not yet recruiting ➔ Completed

Trial completion • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • CCL22 • IL13 • IL5 • POSTN

Belenos Biosciences Announces Positive Topline Results from a Phase 2 Clinical Trial of BEL512 in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (Businesswire) - "'The study met its primary and secondary endpoints with statistically significant improvements in the ‘512 treatment groups vs placebo at W24. Improvements were achieved by W4 and durable effects were observed throughout the treatment and follow-up periods. ‘512 was well tolerated across all dosing groups with overall treatment-emergent adverse events (TEAEs) rates similar to placebo....Keymed is rapidly moving to initiate a Phase 3 study in CRSwNP in China in the near future and Belenos will be initiating a Phase 3 study ex-China in the first half of 2027. Detailed results are expected to be presented at a scientific meeting and submitted for publication in a peer-reviewed medical journal."

New P3 trial • P2 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Keymed Biosciences…is pleased to announce that…R&D product CM512 (a TSLP/IL-13 bispecific antibody) has been included in the Breakthrough Therapy Designation List by the Center for Drug Evaluation of the National Medical Products Administration for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) (HKEXnews)

Breakthrough therapy • Chronic Rhinosinusitis With Nasal Polyps • Immunology

First-in-human, phase 1 study of CM512, a TSLP/IL-13 bispecific antibody, in healthy volunteers: safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. (PubMed, Front Immunol) - P1 | "It significantly reduced free target cytokines and type 2 inflammation biomarkers, supporting further clinical investigation for type 2 inflammatory diseases. https://clinicaltrials.gov/, identifier NCT06553209."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Allergic Rhinitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • TSLP

A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=246 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Belenos Pipeline Updates: First Clinical Data from Lead Asset BEL512, a Long-lasting Bispecific Targeting TSLP and IL-13... (Businesswire) - "The Phase 1b testing two doses (300 mg and 600 mg) of BEL512 vs placebo highlighted significant and durable responses: EASI 75 300 mg group at week 6 of 50% vs 7% in placebo groups; EASI 75 300 mg group at week 12 of 58% vs 21.4% in placebo groups; EASI 90 300 mg group at week 12 of 41.7% vs 0% in placebo groups; These improvements were sustained through to week 24, 20 weeks after the last dose of ‘512. Both serum TSLP and IL-13 rapidly decreased after initial dose, reaching levels below the lower limit of quantification. TARC, eotaxin-3, CCL13, and IgE decreased after the first dose, and reductions were sustained through the 24 week study."

P1 data • Atopic Dermatitis

Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=110 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Sep 2025 | Trial primary completion date: Sep 2026 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology