Admittedly big differences in size (Ns)/stage (PofC vs P3) of trial and extent of disease (mild vs severe), but IPIX results do seem to suggest Brilacidin's big-time potential… remission rates of 50%+ vs 18% for Zeljanz… looking fwd to the final data set!
Below what I found:
Pfizer primary efficacy was based on Total Mayo Score 2pts or lower, with Mucosal healing (Mayo endoscopic subscore of 0 or 1) a secondary outcome… IPIX has the Mucosal healing (endoscopic subscore of O or 1) as part of their Primary Outcome – Clinical Remission definition.
So kudos to them by having Endoscopy (mucosal healing) as part of Remission criterion / definition.
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BRILACIDIN PRIMARY OUTCOME MEASURE / DEF OF REMISSION
From Interim PR
"The Primary Efficacy Endpoint of the Brilacidin UP/UPS trial uses Modified Mayo Disease Activity Index (MMDAI) scoring, a common measurement tool in managing Ulcerative Colitis preferred by many IBD specialists, to determine Clinical Remission at Day 42, as defined by meeting all three contributing criteria:
- Stool Frequency (SF)—an improvement or no change from baseline - Rectal Bleeding (RB)—subscore = 0 (no blood seen) - Endoscopy Findings (EF)—subscore ≤ 1 (mild disease; normal or inactive disease) PFIZER PRIMARY OUTCOME MEASURE / DEF OF REMISSION
Primary Outcome Measure Percentage of Participants With Remission at Week 8 [ Time Frame: Week 8 ] Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Secondary Outcome Measures [one of many] Percentage of Participants Achieving Mucosal Healing at Week 8 [ Time Frame: Week 8 ] Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1.
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