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ICO THERAPEUTICS ANNOUNCES POSITIVE STUDY RESULTS AND SIGNIFICANT ADVANCES RELATED TO ORAL AMPHOTERICIN B PROGRAM

iCo Therapeutics Inc. (ICO.V) has made several developments related to its novel, patent-protected formulation of generic amphotericin B:

  • positive oral amphotericin B (oral amp B) study results exhibited pharmacokinetic (PK) and tissue accumulation data with clinical and commercial relevance:
  • demonstrating scalable and stable drug product, now at a higher dose form
  • once daily regime may be possible for our drug candidate in certain indications
  • targeting treatment of multiple fungal indications, latent HIV reservoirs, and certain developing world parasitic conditions
  • complimenting existing drugs such as liposomal intravenous Amphotericin B (IV Amp B) which generated global sales in excess of $400M USD in 2016.
  • Company anticipates a grant funding increase from existing sources through March 31, 2017 which will allow completion of pivotal IND enabling study and entrance into Phase 1a study with no impact on corporate financial runway
  • Timelines for completion of Phase 1a study in 2017
  • iCo is now engaged in multiple strategic partnering discussions related to Oral Amp B candidate
  • Multiple filings of new intellectual property related to iCo's novel carrier system utilized with our Oral Amp B candidate, including coverage of formulations comprising protease inhibitors and uses for the treatment of HIV

"Given our significant progress in contract manufacturing and pre-clinical development we have a highly differentiated Oral Amp B lead candidate rapidly making its way into the clinic" stated Andrew Rae, President and CEO. "Assuming clinical data reflects meaningful pre-clinical outcomes we believe we may address markets in excess of a billion dollars with an asset that makes administration far more accessible to a broad population."

"I look forward to the entrance of our Oral Amp B candidate into clinical trials and I am pleased to see continued promising results from our pre-clinical study recently completed", stated Kishor Wasan Professor and Dean, College of Pharmacy and Nutrition at the University of Saskatchewan and Adjunct Professor and Distinguished Scholar at the University of British Columbia, and co-inventor of the technology with Dr. Ellen Wasan.

Background

  • IV Amp B is a drug of choice for certain life threatening systemic fungal infections
  • IV Amp B efficacy is well documented
  • Early evidence to suggest that Amp B may activate latent HIV reservoirs which could improve current and future anti-viral therapy outcomes.
  • Need for oral formulation, preferably a solid dosage form with modest administration burden, exists

Summary of Manufacturing and Experimental Results

New oral formulation prototypes were developed and tested in a pre-clinical model. Rate of absorption and tissue accumulation was compared to original prototype which has shown excellent results in multiple pre-clinical models including Candida, Aspergillosis and Visceral Leishmaniasis. Stability data is now approaching month six for our lead clinical candidate and ease of manufacturing scale up should provide additional product differentiation.

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 partnership 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 OTCQX under the symbol "ICOTF".