Acuity Pharmaceuticals has announced it has entered into a license option agreement with ZaBeCor Pharmaceutical Co. for exclusive development and commercialization rights to ophthalmic applications of a novel agent with the potential to treat a variety of inflammatory disorders.
The agent is a small interfering RNA that is designed to silence Syk kinase, a key gene associated with inflammation.
It has shown promising activity and safety in preclinical studies for the treatment of asthma and other inflammatory conditions. ZaBeCor is developing the anti-inflammatory siRNA for pulmonary use under the trade name Excellair™.
This is the second licensing agreement Acuity has announced in the past two weeks and it gives Acuity a pipeline that now includes a total of five preclinical and clinical stage programs for ophthalmic diseases, all based on novel technology platforms.
Acuity's lead compound, Cand5, which represents the first-ever clinical use of RNA interference technology, is currently in clinical trials to treat wet age-related macular degeneration and diabetic macular edema (DME).
Separately, Acuity announced that it has completed patient enrollment in a Phase II trial of Cand5 in DME, its second indication.
"Its broad potential in ocular inflammatory disorders makes ZaBeCor's siRNA an important addition to our pipeline," said Dale Pfost, Ph.D., president and CEO of Acuity.
"We intend to apply our growing expertise in the development of novel ophthalmic therapies to advance this compound into clinical trials with the same focus and efficiency we have achieved with Cand5, as exemplified by our announcement today of the successful completion of patient enrollment in our Phase II DME study on-budget and ahead of schedule."
The siRNA silences the Syk kinase gene, a key cell-signaling molecule that has been shown to be central in initiating critical elements of the inflammatory response in a number of disease models.
Preliminary data suggest that it may have utility in inflammatory conditions of the eye, including uveitis and ocular allergies, and it also may have the potential to prevent the inflammation that contributes to vision loss in conditions such as macular degeneration.
"We are very pleased to be working with Acuity, a pioneer in RNAi therapeutics with demonstrated capabilities to advance ophthalmic siRNA compounds through the clinical development process," said Dr. Alan Schreiber, founder and scientific chairman of ZaBeCor and professor of medicine at the University of Pennsylvania.
"The new technology of RNAi enables us to address the Syk kinase target, which is of central importance in the release of inflammatory mediators."
"This technology has the potential to achieve significant efficacy and safety advantages in a number of applications."
The license option agreement provides for Acuity to receive exclusivity in ophthalmology for ZaBeCor's portfolio of strong patents - both issued and allowed - for nucleotide drugs, including siRNA, that address the Syk kinase target.