Business
AnaptysBio Announces Second Quarter 2021 Financial Results and Provides Pipeline Updates
Imsidolimab GPP GEMINI-1 Phase 3 trial anticipated to initiate in Q3 2021 following recent FDA end-of-Phase 2 MeetingImsidolimab GALLOP GPP Phase 2 trial
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Imsidolimab GPP GEMINI-1 Phase 3 trial anticipated to initiate in Q3 2021 following recent FDA end-of-Phase 2 MeetingImsidolimab GALLOP GPP Phase 2 trial 16-week data to be orally presented at the EADV Congress on October 2nd, 2021Imsidolimab Phase 2 trials ongoing in acne, hidradenitis suppurativa, EGFR-mediated skin toxicity and ichthyosis, with multiple top-line data readouts anticipated in 2022Rosnilimab, previously referred to as ANB030, Phase 1 healthy volunteer top-line data and initiation of a Phase 2 trial in alopecia areata anticipated in Q4 2021JEMPERLI (dostarlimab), our PD-1 antagonist antibody, which our partner GlaxoSmithKline (GSK) anticipates to reach peak annual sales of £1-£2 billion, was approved for endometrial cancer in the US and EU, earning $30 million in cash milestones in Q2 2021 and 8-25% royalties on global net sales of JEMPERLI going forward SAN DIEGO, Aug. 09, 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 second quarter ended June 30, 2021 and provided pipeline updates. “We continue to make progress in advancing our wholly-owned pipeline and look forward to multiple clinical data readouts over the upcoming 18 months,” said Hamza Suria, president and chief executive officer of AnaptysBio. “The recent approval of JEMPERLI, which is the first AnaptysBio-generated antibody to be approved in the US and EU, validates AnaptysBio’s antibody discovery platform and provides additional revenues to support our capital-efficient business model.” Imsidolimab (Anti-IL-36 Receptor) Program Following an end-of-Phase 2 meeting with the FDA in Q2, we publicly disclosed trial designs for our imsidolimab generalized pustular psoriasis (GPP) Phase 3 trials, called GEMINI-1 and GEMINI-2. We anticipate initiating GEMINI-1 in Q3 2021. The primary endpoint of our Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4 of GEMINI-1, while GEMINI-2 is designed for 6 months of safety follow-up assessment.We continue to enroll GPP patients ...