AnaptysBio’s Dermatology Drug Hits Roadblock in Phase 2 Trial

AnaptysBio, a clinical-stage biotech company focused on developing immune control mechanisms for inflammation and oncology, announced on March 8th that their anti-IL-36R drug (Imsidolimab) failed to meet primary endpoints in Phase 2 clinical study (POPLAR). Imsidolimab was used to treat moderate to severe palmoplantar pustulosis (PPP), which is a rare, inflammatory disorder that leaves behind blister-like sores on the palms of the hands and soles of the feet.

AnaptysBio’s stocks crashed by more than 33% amidst POPLAR’s failure. The company has decided to pause development of imsidolimab in PPP but is pushing forward in five other categories including, generalized pustular psoriasis; acne; hidradenitis suppurativa, where swollen, painful lumps rise from under the skin; ichthyosis, a multitude of rare, genetic skin diseases with dry, thickened, scaly skin; and additional skin-related side effects caused by EGFR-targeting cancer medicines.

Hamza Suria, President and Chief Executive Officer of AnaptysBio, said, “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. 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

POPLAR is a Phase 2 multicenter clinical trial that aimed to demonstrate the efficacy and safety of imsidolimab in patients with moderate to severe PPP. The study enrolled a total of 59 patients who were treated with imsidolimab four times in a span of 3 months. While 30 patients received the drug, 29 patients were enrolled in the placebo group.

This trial’s primary endpoint was the mean change in Palmoplantar Pustular Psoriasis Area Severity Index (PPPASI) after 16 weeks relative to the baseline. There was no significant difference in PPPASI between the placebo group and the drug-treated group, and no safety concerns were observed.

Company Pipeline

AnaptysBio needs to tread carefully while bringing its drugs to the market as it has previously suffered tremendous setbacks. For instance, etokimab, which they thought would help treat eczema, failed miserably in a Phase 2 trial where patients taking the drug fared worse than the placebo group. This led to an approximate 70% plunge in AnaptysBio’s stocks.

Meanwhile, the company is formulating an anti-PD-1 drug for treating alopecia areata and vitiligo and also intends to bring to the market an anti-BTLA drug for inflammatory diseases. Additionally, over the years, the San Diego-based biotech has fostered partnerships with giant biopharma’s including GlaxoSmithKline and Bristol Myers Squibb and will be developing cancer drugs and psoriasis/inflammation drugs with them, respectively.

Related Article: Neurocrine, Takeda Look to Build on Positives Post Luvadaxistat’s Schizophrenia Trial Failure

Author

Tulip Chakraborty