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AnaptysBio Reports Imsidolimab POPLAR Phase 2 Clinical Trial in Moderate-to-Severe Palmoplantar Pustulosis (PPP) Did Not Meet Primary Endpoint
Imsidolimab treatment did not demonstrate statistically significant improvement over placebo in PPPASI change from baseline at week 16 primary
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Imsidolimab treatment did not demonstrate statistically significant improvement over placebo in PPPASI change from baseline at week 16 primary endpointImsidolimab was generally well tolerated and no serious or severe adverse events were reported in the drug arm of the trialAnaptysBio does not currently plan to conduct further clinical development in PPPAdvancement of imsidolimab to continue across 5 other distinct indications, including anticipated advancement into Phase 3 trial in generalized pustular psoriasis (GPP) in mid-2021 SAN DIEGO, March 08, 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 announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe palmoplantar pustulosis (PPP), also known as the POPLAR trial, failed to meet its primary endpoint. While further clinical development in PPP is not currently anticipated, AnaptysBio will continue development of imsidolimab in five other immuno-dermatological indications, including GPP, EGFRi-mediated skin toxicity, ichthyosis, hidradenitis suppurativa and acne. Initiation of a Phase 3 clinical trial in GPP is anticipated during mid-2021 following completion of protocol alignment with the FDA. “While the top-line results are disappointing, I would like to sincerely thank everyone involved in the POPLAR trial, including the patients, the investigators, their staff and our employees,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Imsidolimab is currently being advanced in 5 other immuno-dermatology indications and we look forward to multiple additional clinical readouts during 2021 and 2022.” POPLAR Trial DataTop-line data from the POPLAR trial are as follows: Mean baseline Palmoplantar Pustular Psoriasis Area Severity Index (PPPASI) scores were 16 for the 30 patients enrolled in the imsidolimab arm and 19 for the 29 patients enrolled in the placebo arm, with an overall average of 18. Mean baseline Palmoplantar Pustulosis Investigator Global Assessment (PPPIGA) was 3.1 for each arm. Patients were on average 50 years of age and 78% were female.The primary endpoint of least-squares mean di...