BEVERLY, Mass., Dec. 13, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Company approval to start its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers.
A total of nine subjects will be enrolled in the trial, three subjects per cohort. Each subject will receive one treatment at one assessment visit only. In each cohort, two subjects will receive Brilacidin, and one subject will receive placebo. An expedient clinical trial, dosing of all cohorts is expected to be completed within several weeks of commencement; top-line data are anticipated within a few weeks, thereafter.
The study is to be the first in a series of clinical trials, as part of the Company’s Ulcerative Colitis (UC) clinical program. The worldwide UC market was valued at $6.85 billion in 2018, with significant premiums being paid for novel oral Inflammatory Bowel Disease (IBD) treatments in development given shortcomings in current treatment regimens.
Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:
To visualize, using gamma scintigraphy:
º the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
º the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.
“It’s exciting to soon start, in collaboration with our IBD formulation partner, BDD Pharma, a scientifically-rigorous study of Brilacidin’s potential as a novel oral IBD drug candidate,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “There is a considerable market need for innovative non-corticosteroid and non-biologic IBD therapies, as which we believe Brilacidin, based on its unique drug properties and characteristics, is well-positioned to emerge. We already have established Brilacidin’s potential in treating Ulcerative Proctitis/Ulcerative Proctosigmoiditis, when delivered locally, leading to a licensing agreement signed with a global Pharma. A successful Phase 1 study of oral Brilacidin in healthy volunteers demonstrating our ability to target drug delivery would provide additional value to our shareholders as we continue to develop Brilacidin for IBD.”
A total of nine subjects will be enrolled in the trial, three subjects per cohort. Each subject will receive one treatment at one assessment visit only. In each cohort, two subjects will receive Brilacidin, and one subject will receive placebo. An expedient clinical trial, dosing of all cohorts is expected to be completed within several weeks of commencement; top-line data are anticipated within a few weeks, thereafter.
The study is to be the first in a series of clinical trials, as part of the Company’s Ulcerative Colitis (UC) clinical program. The worldwide UC market was valued at $6.85 billion in 2018, with significant premiums being paid for novel oral Inflammatory Bowel Disease (IBD) treatments in development given shortcomings in current treatment regimens.
Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:
To visualize, using gamma scintigraphy:
º the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
º the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.
“It’s exciting to soon start, in collaboration with our IBD formulation partner, BDD Pharma, a scientifically-rigorous study of Brilacidin’s potential as a novel oral IBD drug candidate,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “There is a considerable market need for innovative non-corticosteroid and non-biologic IBD therapies, as which we believe Brilacidin, based on its unique drug properties and characteristics, is well-positioned to emerge. We already have established Brilacidin’s potential in treating Ulcerative Proctitis/Ulcerative Proctosigmoiditis, when delivered locally, leading to a licensing agreement signed with a global Pharma. A successful Phase 1 study of oral Brilacidin in healthy volunteers demonstrating our ability to target drug delivery would provide additional value to our shareholders as we continue to develop Brilacidin for IBD.”
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