Belenos Reports Promising Phase 1b Results for BEL512 Bispecific in Atopic Dermatitis
核心洞察
Belenos Biosciences (搜索) announced positive Phase 1b results for BEL512 (搜索), a novel TSLP (搜索)/IL-13 (搜索) bispecific antibody, showing 58% of patients achieved EASI-75 response at week 12 compared to 21.4% on placebo.
The drug demonstrated an extended half-life of up to 70 days, supporting long-interval dosing with sustained clinical improvements maintained for over 12 weeks after just three doses.
BEL512 (搜索) showed favorable safety profile with significant suppression of key inflammatory biomarkers including TARC, IgE, IL-13 (搜索), TSLP (搜索), and eotaxin-3 in moderate-to-severe atopic dermatitis (搜索) patients.
Belenos Biosciences (搜索) reported encouraging Phase 1b results for BEL512 (搜索), a novel bispecific antibody targeting TSLP (搜索) and IL-13 (搜索), demonstrating rapid and sustained clinical improvements in patients with moderate-to-severe atopic dermatitis (搜索). The study, conducted by partner Keymed Biosciences (搜索) in China, represents the first clinical data for a bispecific agent in this patient population.
Strong Efficacy Signals with Extended Dosing
The Phase 1b study (n=46) evaluated two doses of BEL512 (搜索) (300 mg and 600 mg) against placebo, with patients receiving three subcutaneous treatments over one month on Days 1, 15, and 29. The 300 mg dose group achieved notable clinical responses, with 50% of patients reaching EASI-75 at week 6 compared to 7% in the placebo group. This response improved further to 58% at week 12 versus 21.4% for placebo.
More impressively, 41.7% of patients in the 300 mg group achieved EASI-90 at week 12, while no placebo patients reached this stringent endpoint. These clinical improvements were sustained through week 24, representing 20 weeks after the final dose administration.
Pharmacokinetic Profile Supports Convenient Dosing
BEL512 (搜索) demonstrated a half-life of up to 70 days, engineered through half-life extension technology. This extended pharmacokinetic profile supports the potential for long-interval dosing regimens, addressing a key unmet need in chronic inflammatory disease management.
Comprehensive Biomarker Suppression
The bispecific antibody achieved rapid and sustained suppression of key inflammatory biomarkers. Both serum TSLP (搜索) and IL-13 (搜索) levels decreased rapidly after the initial dose, reaching levels below the lower limit of quantification. Additional inflammatory markers including TARC, eotaxin-3, CCL13, and IgE also decreased after the first dose, with reductions maintained throughout the 24-week study period.
Favorable Safety Profile
BEL512 (搜索) was well-tolerated across all dose groups, with no safety concerns identified. The incidence of treatment-emergent adverse events was similar between placebo and treatment groups, supporting the drug's clinical development potential.
Expanding Clinical Program
"These first patient data underscore the potential '512 has to deliver rapid, deep, durable disease control," said Donnie McGrath, MD, CEO of Belenos Biosciences (搜索). The company is currently conducting a proof-of-concept study of BEL512 (搜索) in patients with mild-moderate asthma (搜索) in the United States, with results expected in 2026.
Keymed Biosciences (搜索) is simultaneously advancing five Phase 2 studies in China evaluating BEL512 (搜索) across multiple inflammatory conditions, including chronic obstructive pulmonary disorder (搜索), asthma (搜索), chronic rhinosinusitis with nasal polyps (搜索), chronic spontaneous urticaria (搜索), and atopic dermatitis (搜索).
Pipeline Expansion with BEL536
Belenos is also advancing BEL536 (搜索), a first-in-class long-acting bispecific antibody targeting OX40L (搜索) and IL-13 (搜索). The company has filed a Clinical Trial Notification in Australia and plans to initiate Phase 1 studies in the first quarter of 2026. This dual-targeting approach is designed to provide rapid symptom relief through IL-13 and OX40L blockade while potentially achieving durable disease remission.
Dr. McGrath noted that the multiple clinical readouts expected in 2026 will support advancement toward pivotal programs in 2027. Founded in 2024, Belenos licensed all ex-China rights for both BEL512 (搜索) and BEL536 (搜索) from Keymed Biosciences (搜索), positioning the company to develop these assets across global markets outside China.