Focus will be on Combining Nicox’s New Nitric Oxide Donating Compounds with pSivida’s Bioerodible Sustained Release Delivery Technology
Sophia Antipolis, France and Watertown, Mass, United States
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, and pSivida Corp, (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced their entry into a collaboration agreement to explore the potential of combining Nicox’s nitric oxide (NO)-donating compounds with pSivida’s bioerodible sustained release drug delivery system, to develop a sustained release drug to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Nicox and pSivida will collaborate on the selection of NO-donating product candidates from Nicox’s research portfolio to combine with pSivida’s sustained release drug technology. pSivida will be responsible for initial development activities of ocular insert formulations, for which it will receive undisclosed sums by Nicox. The companies may then elect to proceed with further development, including more detailed non-clinical studies to generate pre-clinical data, and the evaluation of further compounds under the collaboration. Nicox would make additional payments for any incremental development activities for each implant formulation product candidate selected by Nicox to progress in development. New intellectual property from the collaboration relating to the drug-device combination will be jointly owned. Nicox and pSivida will negotiate a separate license agreement for any product candidate that the two companies wish to further develop and potentially commercialize as a result of this collaboration. Expected payments from Nicox associated with this agreement are not considered material to Nicox’s financial statements at this time.
Michael Bergamini, Executive Vice President and Chief Scientific Officer, stated “We have strong pre-clinical data demonstrating the IOP lowering effect of our novel stand-alone NO donors, such as our lead NCX 667, and believe that their profile makes them product candidates for potential sustained release delivery. The bioerodible technology in development by pSivida, combined with their proven success in developing sustained delivery devices for the eye, puts them at the forefront of this exciting area.”
“Nicox’s NO-donating research platform has been validated in both pre-clinical and human studies for the reduction of IOP.” commented Nancy Lurker, President & CEO of pSivida, “Combining this novel approach to IOP lowering with our bioerodible, sustained delivery device could offer a unique therapy alternative or adjunct to existing therapies to lower IOP in order to help prevent the development and progression of glaucoma.”
Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual loss. Glaucoma can eventually lead to blindness if not treated. Glaucoma is frequently linked to abnormally high intraocular pressure (IOP), due to blockage or malfunction of the eye’s aqueous humor drainage system. Current medications are targeted at reducing IOP to slow the progression of the disease. Numerous eye drops are available to either decrease the amount of fluid produced in the eye or improve its flow out of the eye. A significant portion of patients with open-angle glaucoma require more than one medication to lower their IOP within target levels, highlighting the need for more effective treatments.
About Nicox’s next generation of stand-alone NO-donors
Nicox’s research team has engineered a novel chemistry for a next generation of stand-alone NO-donating molecules with the potential to optimize NO dosing to be used alone or in combination with existing standard-of-care drugs, either as topical eye drops or in sustained intraocular drug-delivery devices. The preclinical results obtained after repeat dosing in rabbit models of glaucoma demonstrate rapid and sustained IOP-lowering compared to vehicle following repeated dosing one hour apart over the course of four hours with no signs of tachyphylaxis or ocular discomfort1. Furthermore, NO-donors result in low tolerance liability as they were found to repeatedly lower IOP on assessed days in these models following twice daily administration over seven days. Similar tolerance liability results were found in non-human primates.
1. Repeated dosing of NCX 667, a new nitric oxide (NO) donor, retains IOP-lowering activity in animal models of glaucoma, E. Bastia, F. Impagnatiello, E. Ongini, J. Serle, M. Bergamini. Presented at ARVO 2017