AnaptysBio, Inc. is a clinical-stage biotechnology company that is developing its first in class antibody products that are focused on the unmet medical needs in inflammation. It announced the top-line data from its ATLAS trial.
This trial was a Phase 2b randomized, placebo-controlled, double-blinded, multi-dose study in approximately 300 adult patients treated with etokimab from moderate-to-severe atopic dermatitis.
As a result of this trial, each one of the etokimab dosings failed to fulfil the primary endpoints of the trial that included the demonstration of a statistically great improvement in the Eczema Area and the Severity Index (EASI) relative placebo at week 16.
The company will now be receiving more details and a plan so that they can provide an update later next year in the first quarter.
As of now, they have decided to postpone the initiation phase of the Phase 2b etokimab’s clinical trial in eosinophilic asthma, until they get the opportunity to be able to analyze the complete data set from the ATLAS trial fully.
The Company will, however, continue conducting its ECLIPSE trial which is a randomized, placebo-controlled Phase 2 trial on approximately 100 patients(adults) suffering from chronic rhinosinusitis with the top-line data from an interim analysis that is expected to be done in the first quarter of 2020.
President Hamza Suria’s comments about the trial:
Here’s what the President and the chief executive officer of AnaptysBio, Hamza Suria has to say about this trial;
“We are surprised and very disappointed by the top-line results of the ATLAS trial.” He also added; “We would like to thank all involved in the participation and support of the ATLAS study, including the patients, the investigators, their staff and our employees. We look forward to continuing our strategy of advancing our wholly-owned clinical and preclinical pipeline programs.”
About AnaptysBio’s eczema drug:
The drug anti-IL-33 antibody used for the treatment of eczema initially cleared the mid-stage study in asthma last year but later failed to pass the phase 2b trial testing in eczema or atopic dermatitis.
It did a worse job at easing symptoms like skin itching or inflammation than even placebo even after 16 weeks of continuous treatment, and due to this, it’s stock tanked more than 70% in the pre-market trading.
According to ClinicalTrials.gov, the ATLAS study performed on the drugs took four doses of etokimab against placebo in 300 adult patients of eczema in their moderate to severe eczema, and all four of these doses missed the primary phase II endpoint.
The drug put up some proof data in peanut allergy but later as questions about the size of the study and about its authenticity were raised, the indication was removed from the company’s page.
This is all there is at this stage. However, more information is expected to come out next year, in the fall of 2020, as the company is expected to conduct further analysis on the complete data.