Business
AnaptysBio Announces First Quarter 2021 Financial Results and Provides Pipeline Updates
Imsidolimab Phase 3 GPP trial anticipated to commence in mid-2021 following FDA end-of-Phase 2 meeting held during Q2 2021JEMPERLI (dostarlimab), our PD-1
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Imsidolimab Phase 3 GPP trial anticipated to commence in mid-2021 following FDA end-of-Phase 2 meeting held during Q2 2021JEMPERLI (dostarlimab), our PD-1 antagonist antibody partnered with GlaxoSmithKline (GSK), was approved for endometrial cancer in the US and EU during Q2 2021, earning $30 million in cash milestones and 8-25% royalties, plus Zejula (niraparib) 1% royalty revenue earned starting January 2021Expanded imsidolimab clinical development program with initiation of Phase 2 trials in acne and hidradenitis suppurativa, with top-line data readouts anticipated in H1 2022 and H2 2022, respectivelyTop-line data from POPLAR phase 2 clinical trial of imsidolimab monotherapy in palmoplantar pustulosis (PPP), disclosed in Q1 2021, failed to meet primary endpointOngoing healthy volunteer Phase 1 trial with ANB030, with top-line data anticipated in H2 2021 and initiation of Phase 2 clinical trials in alopecia areata and vitiligo in Q4 2021Achievement of first-in-human dosing of ANB032 with healthy volunteer Phase 1 top-line data anticipated in H1 2022 SAN DIEGO, May 04, 2021 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the first quarter ended March 31, 2021 and provided pipeline updates. “We look forward to advancing imsidolimab into a Phase 3 trial for GPP following our recent end-of-Phase 2 meeting with the FDA,” said Hamza Suria, president and chief executive officer of AnaptysBio. “AnaptysBio continues to pursue a capital-efficient business model where partnership revenues continue to support advancement of our wholly-owned pipeline poised to generate multiple clinical data catalysts through 2021 and 2022.” Imsidolimab (Anti-IL-36 Receptor) Program We held an end-of-Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease Phase 3 development plan for imsidolimab for the treatment of GPP and anticipate announcing key aspects of our Phase 3 trial design upon its initiation in mid-2021. Our worldwide registry of GPP patients, named RADIANCE, is ongoing, and we expect that this study will improve our understanding of the patient journey and support enrollment of our Phase 3 ...