Innovation Pharmaceuticals eyes Phase 2 trial for Ulcerative Colitis
Category: #health  By Pankaj Singh  Date: 2020-03-07
  • share
  • Twitter
  • Facebook
  • LinkedIn

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



About Author

Pankaj Singh

Email: [email protected]   

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...

Read More

More News By Pankaj Singh

Anova Enterprises expands AnovaOS™ to boost clinical development
Anova Enterprises expands AnovaOS™ to boost clinical development
By Pankaj Singh

The U.S-based Anova Enterprises, Inc. (Anova) has reportedly expanded the AnovaOS™ technology platform in order to boost the development of promising novel treatments. The platform brings pharmaceutical companies...

Serum Institute to Resume Oxford COVID-19 Vaccine’s Trail in India
Serum Institute to Resume Oxford COVID-19 Vaccine’s Trail in India
By Pankaj Singh

India’s Drugs Controller General (DCGI) has approved Pune-based Serum Institute of India (SII) to restart the clinical trial of the Oxford/AstraZeneca COVID-19 vaccine in India.

Everest Medicines Announces Cefepime-Taniborbactam Phase 1 Results

Everest Medicines Announces Cefepime-Taniborbactam Phase 1 Results
By Pankaj Singh

Everest Medicines announced the top-line results from the Phase 1 clinical trial of Taniborbactam with cefepime for treating infections caused by multi-drug resistant pathogens in China. Everest Medicines is a biopharm...