Late in June, iCo Therapeutics (TSX-V: ICO)(OTCQB: ICOTF), along with its subsidiary iCo Therapeutics Australia, disclosed meeting the primary endpoint of safety and tolerability of iCo-019, also called oral Amphotericin B, in a phase 1study of four ascending doses in 32 healthy volunteers. Monday morning, the Vancouver-based company followed that data with news that the key secondary endpoint of positive pharmacokinetics was also achieved in the trial.
Amphotericin B, an injectable known by brand names Ambisome (Astellas Pharma (OTC: ALPMY), Gilead Sciences (NASDAQ: GILD)) and Abelcet, is a prescription antifungal medication used for serious fungal infections and leishmaniasis, a disease spread by sandflies.
iCo specializes in developing drugs that are either off-patent, currently approved or near commercialization and re-dosing or reformulating them into new or expanded uses. iCo leadership believes the study positions the company as the clear leader in developing an oral version of Amphotericin B.
The study demonstrated iCo-019’s ability to enhance systemic drug exposure and extend blood circulation time without gastrointestinal effects or liver and kidney toxicity, even at the highest dosing level. This quality could pave the way for an aggressive treatment regimen, including multiple doses, in the future.
"iCo Therapeutics has a good sense of doses which may be examined in upcoming later staged clinical studies," commented Dr. Kishor Wasan, co-inventor of the technology and Professor and Dean, College of Pharmacy and Nutrition, University of Saskatchewan, in Monday’s news release. iCo now plans to move forward with clinical trials to evaluate the efficacy of the drug candidate in sick patients.
Since trading for months on end stuck essentially between three and four cents per share, ICO stock found its wings in mid-June, starting a run that carried shares as high as 25.5 cents on Thursday. Ahead of today’s news, Toronto-listed shares closed at 24 cents on Friday.