Innovation Pharmaceuticals eyes Phase 2 trial for Ulcerative Colitis
Category: #health  By Pankaj Singh  Date: 2020-03-07
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Innovation Pharmaceuticals eyes Phase 2 trial for Ulcerative Colitis
  • Phase 2 study trial will analyze the safety and efficacy of oral Brilacidin in active ulcerative colitis across 6 weeks.
  • Brilacidin is being introduced in the form of pill as a non-corticosteroid and non-biologic drug.

Innovation Pharmaceuticals is contemplating Phase 2 clinical trial of Brilacidin in pill form with multi-indication potential which is a defensin mimetic drug candidate. The Phase 2 trial will be a novel oral medication for the treatment of ulcerative colitis (UC).

The news surfaced after the company announced plans for patient screening for phase 1 trial in January this year. The phase 1 study revealed the targeted colonic delivery of Brilacidin through the use of delayed-release formulated tablets.

Related news: Patient screening of Innovation Pharmaceuticals’ phase 1 trial in Jan

Reportedly, Phase 2 study trial will analyze the safety and efficacy of oral Brilacidin in active ulcerative colitis across 6 weeks. The company has stressed that part 1 of the trial will include multiple ascending dose (MAD) design of low, mid, high doses and placebo one. Apparently, the main gist of the part 1 of the phase 2 trial will be to decide multiple dose toleration/safety an exposure in ulcerative colitis patients. The enriched PK collection will decide an ideal dose escalation to next cohort.

In its press release, Innovation Pharmaceuticals highlighted part 2 of the trial that would have parallel design of low, mid high doses selected from part 1 and placebo. Meanwhile, the efficacy endpoints would incorporate clinical remission or Mayo Scoring; Biomarkers (CRP, fecal calprotectin, mucosal inflammation’s histologic evaluation); and, patient reported outcomes (PROs).

It is worth noting that Brilacidin is being introduced in the form of pill as a non-corticosteroid and non-biologic drug that has the capacity of treating a continuum of GI diseases with the initial target indication of the ulcerative colitis.

Source credit:

http://www.ipharminc.com/press-release/2020/3/5/innovation-pharmaceuticals-plans-for-phase-2-trial-of-new-treatment-for-ulcerative-colitis



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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