Innovation Pharmaceuticals Inc (IPIX)

[slcimmuno]

Xeljanz UC vs Brilacidin UP/UPS

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

https://clinicaltrials.gov/show/NCT01465763
https://clinicaltrials.gov/show/NCT01458951
https://clinicaltrials.gov/show/NCT01458574

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.