RE:Next week ICO THERAPEUTICS PROVIDES CORPORATE UPDATE, ANNOUNCES COMPLETION OF PHASE 1 RECRUITMENT
iCo Therapeutics Inc. has completed recruitment of all 32 subjects in the company's phase 1 oral Amphotericin B (oral Amp B) study.
Phase 1 oral Amp B clinical trial
The phase 1 Australian study is a randomized, double-masked, placebo-controlled, single-dose ascending study to assess the safety, tolerability and bioavailability of iCo-019 (oral Amphotericin B). Subjects were randomized into one of four cohorts dosed sequentially at 100 milligrams, 200 mg, 400 mg and 800 mg. Each cohort consisted of eight subjects where six subjects were randomized to receive the investigational product and two subjects were randomized to receive a placebo.
The safety profile for each subject dosed in each of the first three cohorts was reviewed by the safety review committee (SRC) before proceeding to a higher dose. With the conclusion of recruitment, safety will be assessed for all subjects in addition to pharmacokinetic profiles.
Amphotericin B is an approved drug for the treatment of fungal and parasitic conditions, but the current leading formulation is an intravenous infusion. iCo Therapeutics is developing a proprietary oral formulation to increase convenience and market application.
The company currently expects results from the phase 1 study in early July, 2018.