February 25, 2020, Vancouver, Canada – iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) (“iCo” or “the Company”) and its subsidiary, iCo Therapeutics Australia Pty Ltd., announced today a positive primary endpoint with respect to its Phase 1b Oral Amphotericin B (Oral Amp B) study. In the Phase 1b study all repeat doses were well-tolerated, with no serious adverse events. There were no signs of kidney or other toxicities.
Dr. Peter Hnik, Chief Medical Officer of iCo, said, “This is a welcome conclusion to our set of Phase 1 studies and the results are very encouraging for our imminent later-stage clinical trials employing the Company’s Oral Amp B candidate. Our success so far confirms our belief that iCo’s Oral Amp B has the potential to address an unmet need for health consumers and the marketplace. We remain on track to launch a Phase 2 study comparing Oral Amp B to fluconazole in a head-to-head study in vulvovaginal candidiasis in Q2 2020.”
Professor Kishor Wasan, co-inventor of the Oral Amp B technology and Amphotericin B expert, noted that “traditionally Amphotericin B has been limited by an intravenous (IV) route of administration and limited therapeutic window. The impressive safety profile of Oral Amp B addresses one of two such limitations. I look forward to the initiation of a Phase 2 study in the near future which will investigate the efficacy of an oral version of Amphotericin B versus current standard of care, potentially addressing the second limitation of the current generic IV version of the drug.”
In the Phase 1b Oral Amp B study, subjects were dosed for 10 consecutive days with additional 10 days of follow-up (for a total of 20 days). Two doses of Oral Amp B (100mg and 400mg), showing promising pharmacokinetic outcomes in the previous Phase 1 trial (using a single dose only), were used in the Phase 1b study. Extensive safety and pharmacokinetic testing was also performed throughout the study to indicate which dose might be the safest and most effective for future trials in patients with fungal disease.
About iCo Therapeutics
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. iCo shares trade on the TSX Venture Exchange under the symbol “ICO” and on the OTCQB under the symbol “ICOTF”.
For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Certain statements included in this press release may be considered “forward-looking information” within the meaning of applicable securities laws. Forward-looking information can be identified by words such as: “anticipate”, “intend”, “plan”, “goal”, “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Forward-looking statements in this press release include statements relating to the timing and completion of the Private Placement and the use of proceeds therefrom. All forward-looking statements are based on iCo’s current beliefs as well as assumptions made by and information currently available to iCo and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Chief Executive Officer
iCo Therapeutics Inc.