June 20, 2018, Vancouver, Canada — iCo Therapeutics (“iCo” or “the Company”) (TSX-V: ICO) (OTCQB: ICOTF), today announced the completion of 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 4 cohorts dosed sequentially at 100 mg, 200 mg, 400 mg and 800 mg. Each cohort consisted of eight (8) subjects where six (6) subjects were randomized to receive the Investigational Product (IP) and two (2) subjects were randomized to receive 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.
We currently expect results from the Phase 1 study in early July 2018.
Phase 2 Bertilimumab Trial
On May 15, 2018 our licensee announced positive Phase 2 data for the treatment of moderate-to- extensive bullous pemphigoid. iCo Therapeutics is eligible to receive up to $32M in potential future milestone payments. For more information please refer to:
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, such as its license with Immune Pharmaceuticals (NASDAQ: IMNP), which is in several Phase 2 studies involving iCo-008. 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.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements 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. 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.
Andrew Rae, CEO 778-772-7775 firstname.lastname@example.org