AnaptysBio Reports Top-Line Data from Interim Analysis of ECLIPSE Phase 2 Clinical Trial of Etokimab in Chronic Rhinosinusitis with Nasal Polyps

• Etokimab q4w and q8w treatment arms failed to achieve NPS and SNOT-22 statistical significance over placebo at this week 8 interim analysis
• Secondary analyses demonstrated NPS and blood eosinophil level improvement in both asthma and non-asthma comorbid patients versus placebo in each etokimab-dosed arm, while ACQ-5 scores were improved in the asthmatic subset
• Blood eosinophil reduction achieved statistical significance over baseline in both etokimab treatment arms
• Etokimab was generally well-tolerated and demonstrated an acceptable safety profile
• Company intends to assess path forward for its etokimab program after reviewing week 16 primary endpoint data by year-end 2020

SAN DIEGO, Aug. 10, 2020 (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 immune-oncology indications, today reported top-line data from a week 8 interim analysis of the Company’s ongoing ECLIPSE Phase 2 clinical trial of etokimab, an anti-interleukin-33 (IL-33) monoclonal antibody, in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). 

Patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and in their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint.  Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22.  Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms.  The Company intends to determine next steps for the etokimab program after reviewing week 16 primary endpoint by year-end 2020. 

“We are disappointed that etokimab did not demonstrate significance over placebo in either treatment arm in this week 8 interim analysis,” said Hamza Suria, president and chief executive officer of AnaptysBio.  “We plan to re-assess the etokimab program following review of the complete week 16 data from the ECLIPSE trial later this year.”

ECLIPSE Trial DesignThis Phase 2 trial enrolled 105 adult chronic rhinosinusitis with nasal polyps patients, who were randomized between three 16-week dosing arms: (i) 300mg subcutaneous (SC) loading dose followed by q4w 150mg SC, (ii) 300mg SC loading dose followed by q8w 150mg SC and (iii) placebo, in each case concomitant with 400 micrograms daily of mometasone furoate nasal spray.  Patients were enrolled, at approximately 25 sites across the United States, with a confirmed diagnosis of CRSwNP, a minimum NPS score of 4 with at least a score of 1 in each nostril and minimum SNOT-22 score of 16 after completion of at least 8 weeks of prior therapy washout.  Each arm was stratified for asthma comorbidity.  This interim analysis was conducted to assess key endpoints through week 8 of treatment.  The co-primary endpoints for this trial are NPS and SNOT-22 change relative to baseline at week 16.  Patients will be followed for an 8-week monitoring period subsequent to the 16-week treatment period.  Missing data values were imputed using a mixed-effect model with repeated measures (MMRM) approach.