IP Group plc

06/26/2024 | Press release | Distributed by Public on 06/27/2024 03:51

Crescendo Biologics announces that Zai Lab has initiated a global Phase 2 clinical trial evaluating ZL-1102 (Humabody®, CB001) as a topical treatment for psoriasis

26 Jun 2024

  • ZL-1102 (formerly CB001) is a fully human VH fragment antibody (Humabody®) targeting IL-17A that was discovered by Crescendo and licensed worldwide to Zai Lab in 2018
  • Zai Lab's progress in the clinical development of ZL-1102 further supports the strength of Crescendo's Humabody® platform in the development of innovative antibody VH domain therapeutics to target hard to treat conditions

Cambridge, UK, 26 June 2024 - Crescendo Biologics Ltd (Crescendo), a clinical stage, immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces that its global partner, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has dosed the first patient in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the IL-17 targeted therapy ZL-1102 (formerly CB001), for the topical treatment of chronic plaque psoriasis.

The preceding Phase 1b study resulted in the declaration of clinical proof-of-concept, where Humabody® VH became the first biologic platform to penetrate psoriatic skin and result in a clinical benefit.

The Phase 2 trial will enrol approximately 250 patients who will receive the topical therapy for 16 weeks. The primary endpoint is the proportion of patients achieving modified PASI75, which is at least a 75% reduction in the modified Psoriasis Area Severity Index (PASI) score from baseline, at week 16. Secondary objectives include efficacy throughout the treatment period, safety, tolerability, pharmacokinetics and anti-drug antibody (ADA). Further information can be found in the press release issued by Zai Lab on 22 May 2024.

Theodora Harold, Chief Executive Officer at Crescendo, said: "Our partners at Zai Lab are making significant progress towards improving the lives of patients with psoriasis, via this topical immunemodulating therapy. This programme also supports and validates the broad formulation possibilities of Crescendo's Humabody® VH platform therapeutics beyond systemic administration. It highlights opportunities for new treatment modalities for patients, and we look forward to closely following the Phase 2 trial's progress."

Under the terms of an exclusive worldwide license agreement for ZL-1102 established between Crescendo and Zai Lab in May 2018, Crescendo granted to Zai Lab worldwide exclusive license to develop and commercialise ZL-1102 for all indications. Zai Lab isresponsible for conducting all regulatory filings, clinical studies and commercialization activities, with Crescendo being eligible for certain development, regulatory, and commercial milestones as well as tiered royalties on global sales. Crescendo previously received a milestone payment in December 2021 following Zai Lab's achievement of proof-of-concept.

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