Oct 9 2014
Aciex Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a U.S. Patent (No. 8,829,005) covering AC-170 Cetirizine Ophthalmic Compositions and a U.S. Patent (No. 8,765,725) covering AC-155 Fluticasone Propionate Nano-crystalline Compositions.
Aciex is a private, US-based ophthalmic development pharmaceutical company with a strong near-term pipeline of therapeutics addressing major segments of the ophthalmic market, including allergy and inflammation.
On July 1, 2014, Nicox S.A. (NYSE Euronext Paris: COX) signed an agreement to acquire Aciex Therapeutics, Inc. For more information, see Nicox press release dated July 2, 2014 available on Nicox’s website.
U.S. Patent No. 8,829,005 contains method of treatment claims that cover Aciex’s cetirizine product candidate (cetirizine ophthalmic solution, 0.24%). U.S. Patent No. 8,765,725 contains both composition of matter and method of uses claims that broadly cover Aciex’s novel nanocrystalline formulations of fluticasone propionate.
AC-170 is a novel formulation of cetirizine (an oral antihistamine, available under brand names including Zyrtec®) being evaluated for the treatment of allergic conjunctivitis. Pending FDA approval, it could become the first topical application of cetirizine in the eye available to patients. Two phase 3 safety and efficacy studies have demonstrated statistically significant results for AC-170 over vehicle control for the primary endpoint of ocular itching. Treatment-emergent adverse events were similar in severity and frequency in the active and vehicle groups. An AC-170 pre-NDA meeting with the U.S. FDA is expected to be held by the end of Q1 2015.
AC-155 is a novel nanocrystalline form of fluticasone (a market leading nasal corticosteroid available/sold under brand names including Flonase® and Flovent®) and is also being developed for the first time for topical ocular administration. It uses Aciex’s proprietary manufacturing process and is being developed for post-operative inflammation and pain. Based on fluticasone’s approximately ten-fold greater affinity for the glucocorticoid receptor, AC-155 will be evaluated at a reduced dosing frequency compared to dexamethasone. AC-155 is expected to move into a phase 2 clinical trial in 2015, subject to agreement by the U.S. FDA, completion of toxicity studies, and IND filing.
Zyrtec® is a trademark of UCB Pharma SA or GlaxoSmithKline; Flonase® and Flovent® are trademarks of Glaxo Group Limited.