iCo meets primary end point for iCo-019 study

iCo meets primary end point for iCo-019 study

2018-06-27 09:53 ET - News Release
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Mr. Andrew Rae reports

ICO THERAPEUTICS ANNOUNCES POSITIVE CLINICAL OUTCOME - PRIMARY ENDPOINT MET IN PHASE 1 ORAL AMPHOTERICIN B STUDY

iCo Therapeutics Inc. 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 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."