Benzinga | May 12, 2021 08:09AM EDT

Connect Biopharma Announces First Patient Doses In Phase 2 Trial Evaluating CBP-201 In Adults With Moderate-To-Severe Persistent Asthma

Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first patient has been dosed in a Phase 2 trial evaluating CBP-201 in adults with moderate-to-severe persistent asthma.



This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of two doses of CBP-201 administered subcutaneously (SC) to eligible patients with moderate to severe persistent asthma with Type 2 inflammation. The trial is expected to enroll approximately 300 patients across 80 clinical sites in the United States, China, European Union, the United Kingdom, Ukraine and South Korea and is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks (NCT04773678).

"Beginning enrollment on the CBP-201 clinical trial offers hope in the pursuit of new, effective treatments for severe asthma," said Dr. Edward M. Kerwin, MD, Founder and Senior Medical Director of the Clinical Research Institute, Allergy and Asthma Center and Altitude Clinical Consulting, and member of the Connect Biopharma Scientific Advisory Board. "The patients that will be enrolled are those experiencing severe exacerbations requiring oral corticosteroid bursts, very high dose inhaled corticosteroids (ICS), and often requiring emergency department visits or hospitalizations. CBP-201 has been designed to use a validated mechanism as a biologic that blocks IL-4 receptor alpha, which would make it capable of blocking both IL-4 and IL-13 that drive allergic asthmatic inflammation."

"Initiation of CBP-201 in persistent asthma is a significant step in our plan to expand our clinical programs into important diseases mediated by the dysregulation of the IL-4 and IL-13 cytokines. Many patients with moderate-to-severe asthma continue to have unmet need and could benefit from additional treatment options," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma. "We see strong potential for CBP-201 to become a treatment that can help these patients to address significant unmet medical needs, and ultimately to enhance their quality of life."

About Type 2 Inflammatory Asthma

Type 2 inflammation, which occurs in more than 80% of children and the majority of adults with asthma, is an important molecular mechanism that gives rise to asthma symptoms. Type 2 inflammation is mediated by type 2 helper T-cells (TH2), which secrete inflammatory cytokines including IL-3, IL-4, L-5, IL-9 and IL-13. While corticosteroids have been a pillar of therapy for patients with type 2 inflammatory asthma, they are associated with multiple local and systemic side effects. Novel therapies that can inhibit aberrant TH2 activity with greater specificity would have the potential to improve the care and outcomes of patients with type 2 inflammatory asthma.