Trial builds on positive Phase 1b data and will help to establish dosing for future Phase 3 trials
SAN DIEGO and TAICANG, SUZHOU, China, July 20, 2020 /PRNewswire/ — Connect Biopharma, a clinical-stage biopharmaceutical company focused on identifying and developing potent and specific immune modulating molecules, today announced that the first patient has been dosed in a Phase 2 clinical trial of CBP-201 for the treatment of moderate-to-severe atopic dermatitis (AD) in adult subjects. CBP-201 is a novel IL-4Rα antibody that, in a Phase 1b trial, demonstrated an efficacy profile superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment.
"The eczematous skin lesions, itching, localized pain, and sleep disturbances associated with AD can interfere with a patient’s ability to engage in physical, social and other routine daily activities," said Brian Feinstein, DO, a Board-certified dermatologist, consultant at Encore Research in Hollywood, Florida, and the first investigator to treat a patient in the Phase 2 study. "Moderate-to-severe disease accounts for about thirty percent of all AD cases. Of these patients, those who do not respond to corticosteroids have few options. The Phase 1b data for CBP-201 are promising and the Phase 2 study initiated today should provide insight as to the potential role it may play in improving overall care and outcomes for patients with moderate-to-severe AD."
In January 2020, Connect Biopharma reported topline results from the Phase 1b trial of CBP-201. These results demonstrated that CBP-201 treatment resulted in rapid improvement in skin lesions as measured by change from baseline in EASI on Day 29, with 42.9% and 50.0% of patients receiving 300 mg or 150 mg of CBP-201, respectively, achieving "clear/almost clear" skin, defined as a score of 0 or 1 in the Investigator’s Global Assessment (IGA) scores, the primary efficacy endpoint required for FDA approval, compared, with 12.5% in the placebo group. The trial also demonstrated that skin lesion improvements were evidenced as early as one week after dosing of CBP-201 and were correlated with a rapid reduction in pruritus intensity and frequency, and that CBP-201 was also well tolerated.
"We believe that CBP-201 has best-in-class potential in the treatment of moderate-to-severe AD and are optimistic that the results of this Phase 2 trial will further differentiate CBP-201 from competitors," said Zheng Wei, PhD, Co-founder and CEO at Connect Biopharma. "IL-4Rα is a validated target for dupilumab, an FDA-approved therapy for the treatment of AD, but unmet medical need remains, with the majority of patients not achieving ‘clear or almost clear’ skin even after 16 weeks of treatment. Data from our Phase 1b trial suggest that CBP-201 has the potential to provide superior efficacy in AD with faster onset of action, and less frequent dosing compared with dupilumab."
The randomized, double-blind, placebo-controlled Phase 2 clinical trial is expected to enroll approximately 220 adults (ages 18 to 75 years) with moderate-to-severe AD across approximately 60 clinical sites in the United States, Australia, New Zealand, China, Europe and the UK. Subjects will be randomized (1:1:1:1) to one of three CBP-201 dosing regimens or placebo administered by subcutaneous injection. Subjects will be treated over 16 weeks and followed for an additional eight weeks following the last dose. The primary objective of the trial is to assess the efficacy of the various dosing schedules in this patient population; secondary objectives are to assess the safety and tolerability and to characterize the steady-state pharmacokinetic profile of the various dosing schedules. Study results are expected in the second half of 2021.
CBP-201 is a potent monoclonal antibody against IL-4Rα, a cell surface protein required for the signaling of both IL-4 and IL-13, which have significant overlapping biological activities and play key roles in inflammatory diseases mediated by type 2 helper T cells (Th2). CBP-201 was discovered internally using Connect Biopharma’s proprietary Immune Modulation Technology Platform and is under clinical development to treat atopic dermatitis and other Th2 inflammatory diseases that have high unmet medical needs.
Previously reported results from a Phase 1b clinical study in adult patients with moderate-to-severe atopic dermatitis showed that CBP-201 has an efficacy profile that is superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment, with a favorable safety profile. The study found that 42.9% and 50.0% of patients receiving CBP-201 300 mg or 150 mg, respectively, achieved clear/almost clear skin at four weeks, which is especially compelling when compared with data from clinical trials of the current standard of care therapy. Additionally, skin lesion improvements were evidenced as early as one week after dosing and were correlated with a rapid reduction in pruritus intensity and frequency. The highly differentiated efficacy profile and faster onset of action, coupled with the potential for dosing every four weeks with CBP-201 compared with every two weeks with the approved biologic therapy, would position CBP-201 for both clinical and commercial success.
About Connect Biopharma
Connect Biopharma is a clinical-stage biopharmaceutical company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation. The company’s proprietary Immune Modulation Technology Platform is a high-throughput screening platform built on the biology of T cell function, and rapidly identifies molecules that target clinically validated disease pathways more efficiently than the traditional discovery approaches.
In addition to CBP-201, the company’s other lead drug candidate is CBP-307, an orally active, next-generation S1P1 and S1P5 modulator for the treatment of a range of autoimmune disorders, including inflammatory bowel disease, psoriasis, and multiple sclerosis. In two completed phase 1 randomized, double-blind, placebo-controlled studies, CBP-307 exhibited an excellent safety profile and potent T cell modulation activity as well as optimal pharmacokinetic and pharmacodynamic profiles, demonstrating best-in-class potential. Two phase 2 studies of CBP-307 are currently underway to evaluate the efficacy and safety of CBP-307 in patients with moderate-to-severe ulcerative colitis and moderate-to-severe Crohn’s disease.
The company is also advancing three preclinical programs, comprising two small molecule candidates (CBP-174 and CBP-312) and one antibody targeting IL-33 (CBP-233) as treatments for various serious inflammatory conditions.
For additional information about Connect Biopharma, please visit http://www.connectbiopharm.com.
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