December 11, 2019, Vancouver, Canada — iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) (“iCo” or “the Company”) today announced it has engaged Ora, Inc., the world’s leading full-service ophthalmic CRO and product development firm, to assist the Company with its ophthalmic regulatory and development strategy for iCo-008. It is expected that this work will ultimately result in a meeting with the FDA prior to initiation of a Phase 2 trial. Ora has vast expertise in ocular allergy and immunology, both pre-clinical and clinical, and has been involved in multiple drug approvals in this area. Paul Gomes, Vice President of Allergy and Blepharitis at Ora, commented, “We are very excited to collaborate with iCo in engaging with the FDA to establish a development pathway for iCo-008 for severe ocular allergic diseases. In the US, there have been no new therapies approved for these orphan diseases within the last 25 years. Innovation is necessary to increase the available treatment options and to reduce or eliminate the need for chronic steroid usage. ”
Previously iCo announced the conclusion of court proceedings in the US and Israel, resulting in approval of Alexion’s asset purchase agreement related to iCo-008, an anti-eotaxin-1 antibody. iCo retains worldwide ophthalmic use indications, including Vernal Keratoconjunctivitis (VKC) and Atopic Keratoconjunctivitis (AKC).
iCo-008 is an antibody which targets eotaxin-1, a ligand to CCR3. The release of eotaxin-1 from certain cells (e.g. epithelial cells, fibroblasts, endothelial cells, T-lymphocytes, monocytes and macrophages) contributes to the local accumulation of eosinophils in inflammatory conditions (eosinophilia). The presence of eosinophils causes further inflammation. iCo-008 locks eotaxin-1 from recruiting eosinophils, thereby reducing inflammation.
Possible Retinal Applications for iCo-008
iCo-008 may also have usefulness in the treatment of a number of retinal indications including wet age-related macular degeneration (“wAMD”). Recent clinical data presented by a competitor at the 2019 Retina World Congress revealed that an oral drug targeting CCR3 in wAMD showed an impressive increase in visual acuity over a short 6-week period of treatment. The potential for gaining meaningful visual improvement with an oral agent in neovascular AMD represents a major step forward for patients with this devastating retinal 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.
About Ora, Inc.
Ora is the world’s leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom, Australia and Japan. Over the past 40 years, we have proudly helped our clients earn more than 45 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.
For more information, please visit www.oraclinical.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.