ANNOUNCES POSITIVE CLINICAL OUTCOME - PRIMARY ENDPOINT MET IN PHASE 1 ORAL AMPHOTERICIN B STUDY
iCo Therapeutics Inc. (ICO.V) and its subsidiary iCo Therapeutics Australia Pty. Ltd. have provided a positive primary end point in their phase 1 clinical study. The study met its primary end point of safety and tolerability of iCo-019 (oral amp B) following oral administration of single ascending doses (four dose levels) in healthy subjects. There were no serious adverse events (SAEs) and no drug-related adverse events (AEs) in either of the four study cohorts. All drug doses were well tolerated, including the highest dose of 800 milligrams, with no indication of kidney toxicity. "This is a very promising result for our future efficacy studies with oral amphotericin B," stated Dr. Peter Hnik, chief medical officer of iCo Therapeutics.
"We are pleased to report a positive primary end point related to our 32-subject phase 1 clinical study," stated Andrew Rae, president and chief executive officer of iCo Therapeutics. "No patients experienced drug-related adverse or serious adverse events in our phase 1 clinical study and we believe this allows us to claim leadership in the race towards developing an oral amphotericin B drug." Mr. Rae also stated, "iCo management waits with anticipation important and material pharmacokinetic data in the coming weeks."
About the phase 1 clinical trial
The phase 1 Australian study conducted was a randomized, double-masked, placebo-controlled, single dose ascending study to assess the safety, tolerability and bioavailability of iCo-019 (oral amphotericin B) in healthy male and non-pregnant female subjects between 18 and 55 years of age. Subjects were randomized into one of four cohorts, each representing an ascending single dose of treatment. Cohorts were dosed sequentially. Each cohort consisted of eight subjects where six subjects were randomized to receive the investigational product (IP) and two subjects were randomized to receive the placebo. A sentinel group consisting of two subjects (one subject receiving the IP and one subject receiving the placebo) were dosed before the other subjects in each cohort. All subjects were followed for seven days after dosing. The safety profile for each subject treated in each cohort was reviewed by the safety review committee (SRC).
About iCo Therapeutics Inc.
iCo Therapeutics identifies existing development stage assets for use in underserved ocular and infectious diseases. Such assets may exhibit utility in non-ophthalmic conditions outside the company's core focus areas and if so the company will seek to capture further value via partnerships, such as its licence with Immune Pharmaceuticals, which is in phase 2 involving iCo-008.