Ocuphire Granted New US Patent for Late-Stage Oral Drug Candidate for Use in Diabetic Eye Disease

Ocuphire Granted New US Patent for Late-Stage Oral Drug Candidate for Use in Diabetic Eye Disease

June 30, 2022

Ocuphire Pharma announced that the United States Patent and Trademark Office (USPTO) has issued a new patent extending expiry and broadening coverage of the company’s late-stage oral product candidate, APX3330, for diabetic eye disease.

In addition, a new publication supporting the novel mechanism of action inhibiting NFkB and the inflammation pathway for APX3330 and the APX pipeline candidates has been published in a peer-reviewed journal.

“We are pleased to announce the issuance of a new U.S. patent that further strengthens our patent estate for APX3330,” Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma, said in a company news release. 

“If approved, oral APX3330 has the potential to address the high unmet need for early intervention for progressive vision-threatening diabetic eye disease, including diabetic retinopathy (DR) and diabetic macular edema (DME). The timing is ideal as we continue to advance our fully enrolled clinical program investigating APX3330 in DR/DME where we have reported interim masked safety results at multiple medical meetings throughout this year demonstrating a consistent and favorable safety profile for a first-in-class oral treatment option. Topline results from the phase 2b ZETA-1 trial are expected in the second half of 2022,” Mrs. Sooch added.  

U.S. Patent No. 11,351,130 has claims directed to methods of treatment using APX3330, which makes it eligible for listing in the FDA Orange Book. It was issued on June 7, 2022 and has a term that expires in year 2038. Claims in this patent include methods of treating inflammation and chronic pain in a subject suffering from diabetes.

This patent complements the company’s patent estate relating to APX3330 and the company’s pipeline products including APX2009 and APX2014, together the subject of over 40 patents directed to ophthalmic and other uses in the U.S., Europe, Japan, and other foreign countries as well as the subject of pending patent applications in the U.S., Europe, Japan, China, and other foreign countries. 

Ocuphire also announced the publication of a preclinical study outlining the pivotal role of NFkB (RelA) in Ref-1 inhibition in a pancreatic ductal adenocarcinoma (PDAC) cell model with a Kras genotype and offers evidence of anti-inflammatory benefits of APX3330 in PDAC.

The publication entitled, “RelA is an Essential Target for Enhancing Cellular Responses to the DNA Repair/Ref-1 Redox Signaling Protein and Restoring Perturbated Cellular Redox Homeostasis in Mouse PDAC Cells” had several key findings such as NFkB being a key target driving pancreatic cell sensitivity to Ref-1 redox inhibition, and confirmed small molecules APX33330, APX2009, and APX2014 suppresses inflammatory process mediated by NFkB pathway.

The full online publication in Frontiers in Oncology can be accessed here: https://doi.org/10.3389/fonc.2022.826617