Shares of Allakos (ALLK 1.61%) are crashing 88% lower as of 10:17 a.m ET on Wednesday. The huge decline came after the company announced results from its phase 3 Enigma 2 and its phase 2/3 Kryptos clinical studies evaluating lirentelimab.
Allakos reported that both clinical studies met their histologic co-primary endpoints. However, neither study achieved statistically significant improvement on patient-reported symptomatic co-primary endpoints.
The biotech stock plunged so much because the co-primary endpoint misses weren't even close. That's especially problematic because lirentelimab is Allokos' only pipeline candidate in clinical development.
Patients in the Enigma 2 study who received a placebo reported a greater absolute change in the six-symptom total symptom score (TSS) than did patients receiving lirentelimab. It was a similar story with the Kryptos study with patients receiving a low dose of the drug. Patients receiving the high dose of lirentelimab reported greater improvement in symptoms than those on a placebo, but it wasn't enough to be statistically significant.
Allakos executives didn't try to spin the results as positive. CEO Robert Alexander said, "We are deeply disappointed that the studies did not achieve their symptomatic endpoints." Chief medical officer Craig Paterson called the results "surprising and disappointing."
Paterson stated that Allokos "at present" plans to continue analyzing the data from the two studies in an effort to determine a path forward for lirentelimab in treating eosinophilic gastrointestinal diseases. The company also plans to continue the development of a subcutaneous version of the drug targeting atopic dermatitis, asthma, and chronic spontaneous urticaria.