AVX completed a Phase 2a study in dry eye subjects earlier this year with its lead product candidate, AVX-012. The active ingredient in AVX-012 is a potent and selective agonist of the TRPM8 ion channel, a cold sensor and osmolarity sensor that regulates ocular surface wetness and blink rate.
By stimulating these processes in a physiological manner, TRPM8 agonists have the potential to restore tear film stability and reduce discomfort in patients with dry eye. Positive results from the Phase 2a study support the therapeutic potential of AVX-012 to treat signs and symptoms of dry eye and Aerie is planning to initiate a larger Phase 2b study in late 2020.
“This acquisition bolsters our pipeline with a clinical-stage dry eye product candidate, and we are excited to expand our footprint in ophthalmology. This product has a novel mechanism-of-action for treating dry eye and we believe that, if approved, it could nicely complement the currently approved drugs for this indication. Since the majority of our efforts in 2020 will be focused on supportive non-clinical studies, we do not currently expect to meaningfully increase our R&D expenditures next year,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
AVX Pharma President and Chief Executive Officer Patrick Tresserras added, “We are thrilled that this transaction will accelerate the development of AVX-012 towards later stage clinical trials. Aerie, as a unique ophthalmology focused company with a track record of developing and commercializing ophthalmic drugs, is well positioned to fulfill our vision of addressing this indication from a new mode of action for the benefit of millions of patients suffering from dry eye disease.”
Under the terms of the Agreement, Aerie will acquire AVX Pharma in an all-cash transaction. Aerie will make an upfront payment of $10 million, subject to customary adjustments, and AVX Pharma shareholders will be eligible to receive additional payments subject to achievement of certain clinical and regulatory performance milestones, plus royalties on net sales of approved products from AVX Pharma’s development pipeline.
In addition to AVX-012, Aerie will also be acquiring rights to other compounds targeting TRPM8. The parties expect to close the acquisition before the end of the year pending the completion of certain pre-closing obligations.
Source: Company Press Release