AnaptysBio's etokimab provides more disappointing results, raising questions about compound's future
The lead program for AnaptysBio’s in-house pipeline has hit another setback.
Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.
AnaptysBio announced the interim results as part of a second-quarter earning readout.
“While we are disappointed with the recent interim analysis results from our ongoing ECLIPSE trial, we look forward to additional Phase II clinical trial readouts anticipated over the upcoming quarters,” AnaptysBio president and CEO Hamza Suria said in a statement.
The company added that it will reassess the plan for the etokimab program following the 16-week marker near the end of 2020.
Monday’s underwhelming results are not the first for etokimab, as chronic rhinosinusitis with nasal polyps is not the candidate’s main target. AnaptysBio originally tested the compound for treatment of atopic dermatitis, hoping to challenge Regeneron and Sanofi’s market-leading Dupixent, but had to discontinue development after both dosing arms of a Phase IIb trial failed to meet the primary endpoint of the study.
That trial flop had been dubbed the “worst-case scenario” by analysts and sunk the company’s stock more than 70% at the time. Investors had expected etokimab to reach similar levels of efficacy to Dupixent with less frequent dosing, but that didn’t happen. The market for atopic dermatitis, which is estimated to affect some 24 million Americans, is expected to hit $18.3 billion by 2027, according to GlobalData.
The candidate is also being studied to treat eosinophilic asthma, but AnaptysBio postponed the Phase IIb trial following the results from the atopic dermatitis study. Per the company’s website, it plans to wait until the full results of the chronic rhinosinusitis study become available before initiating the trial.
Additionally, this is not the first time AnaptysBio has been in the news recently. Just last month, the FDA granted orphan drug designation for imsidolimab, the company’s IL-36 inhibitor to treat generalized pustular psoriasis. Regulators are expected to provide an update on the candidate, which is in a Phase II trial, before 2020 is out.