Huaota Biopharma's IL-17A-Targeting Monoclonal Antibody HB0017 Meets All Primary and Key Secondary Endpoints in Phase 3 Trial for Moderate-to-Severe Plaque Psoriasis, NDA Planned

On November 24, Huaota announced that its self-developed HB0017 injection for treatmentModerate to Severe Plaque PsoriasisThe pivotal Phase 3 clinical trial has completed unblinding and met all primary and key secondary endpoints. The press release stated that this positive outcome lays the foundation for the company to submit a marketing application to China's National Medical Products Administration (NMPA).

HB0017 Injection is a monoclonal antibody targeting interleukin-17A (IL-17A), intended for the treatment of moderate to severe plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases.

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial, enrolling a total of 408 Chinese patients with moderate to severe plaque psoriasis. The study met all pre-specified primary efficacy endpoints (the proportion of subjects achieving PASI 75 at Week 12, the proportion of subjects achieving sPGA 0/1 at Week 12) and key secondary efficacy endpoints (the proportion of subjects achieving PASI 90 at Week 12).

Topline data showed that HB0017 achieved the pre-specified study objectives for both the core treatment period (first 12 weeks) and the maintenance treatment period (weeks 12-52):

• At week 12 of treatment, the proportion of patients in the trial group achieving PASI 75 was 95.7%, compared to 7.4% in the placebo group.

• The proportion of patients in the trial group achieving static Physician Global Assessment clearance or near-clearance (sPGA0/1) was 87.0%, compared to 1.9% in the placebo group.

• Key secondary endpoints were also met, with 88.0% of patients in the trial group achieving PASI 90 at week 12, compared to 1.9% in the placebo group.

During the maintenance dosing phase, HB0017 injectionExtend the dosing interval to 8 weeksAnd the relevant efficacy indicators remained stable and durable; at Week 52 of treatment, the proportion of subjects maintaining lesion clearance or near clearance (sPGA0/1) in the every 4 weeks dosing (Q4W) group and every 8 weeks dosing (Q8W) group were 92.3% and 85.9%, respectively; at Week 52 of treatment, the proportion of subjects achieving PASI 100 in the Q4W group and Q8W group were 79.1% and 65.8%, respectively.The maintenance treatment dosing regimen is expected to extend the dosing interval of existing therapies.

In addition to the completed Phase 3 clinical trial for moderate to severe plaque psoriasis, HB0017 injection is also conducting a Phase 3 clinical trial for ankylosing spondylitis. The HB0017 injection showed statistically significant and clinically meaningful improvement in the completed Phase 2 clinical study for ankylosing spondylitis.

References:
[1]Good News! Huaota's HB0017 Injection for the Treatment of Moderate to Severe Plaque Psoriasis Meets All Primary and Key Secondary Efficacy Endpoints in Phase III Clinical Trial. From https://mp.weixin.qq.com/s/JV284Xq4m21CMZBrcgCFOg

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