Connect Biopharma ( NASDAQ: CNTB ) stock fell ~3% on Oct. 4 despite the company saying that CBP-201 helped patients with atopic dermatitis (AD) achieve clear or almost clear skin, meeting the main goal of phase 2b trial in China.
In the study, patients with moderate-to-severe AD (eczema) were randomized in a 2-to-1 ratio to receive either CBP-201 or placebo control. The primary analysis was from 255 adult patients who had completed Stage 1.
The main goal of IGA of 0 or 1 (clear or almost clear) with at least 2 grades of reduction at week 16 from baseline was significantly greater for the CBP-201 (300 mg every two weeks) group with 30.3% of patients showing improvement compared to 7.5% for those on placebo, the company said in an Oct. 4 press release.
Connect added that CBP-201 also met key secondary goals, including 83.1%, 62.9% and 35.8% of patients achieving a 50%, 75%, 90% reduction in the Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) from baseline compared to 41.1%, 23.4% and 6.3% for the placebo group, respectively.
In addition, 35% of patients on the drug experienced improvement in pruritus (itching), compared to 9.6% for placebo, the company added.
"We are pleased that these positive and important topline results from our pivotal China trial provide potentially NDA-supportive efficacy and safety data for CBP-201," said Connect Co-Founder and CEO Zheng Wei.
Connect noted that treatment-emergent adverse event (TEAEs) of 73.5% was for CBP-201, compared to 72.9% for the placebo group. Serious Adverse Events (SAEs) of 0.6% for CBP-201 versus 3.5% for placebo over the 16-week treatment period.
The incidence of injection site reactions lasting longer than 24 hours was 6.5% for those on the drug while 0.0% in the placebo group.
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Connect stock dips despite eczema drug CBP-201 meeting main goal in China trial