EyeGate Pharma Announces First Patient Dosed for PP-001 in a Phase 2 Proof-of-Concept Ocular Surface Inflammation Study
EyeGate Pharmaceuticals announced the first patient dosed in phase 2 proof-of-concept study evaluating its lead product candidate, PP-001, in patients with ocular surface inflammation due to ocular surface diseases including dry eye. PP-001, an immune-modulating molecule, is an inhibitor of dihydroorotate dehydrogenase (DHODH) and is first-in-class for ophthalmology indications.
“We are pleased to dose the first patient and initiate our proof-of-concept study, an important milestone in our clinical development program for our ocular surface franchise,” Franz Obermayr, PhD, Acting Chief Executive Officer of EyeGate, said in a company news release. “This study builds on encouraging preclinical data and on positive clinical safety data from a phase 1 study in healthy volunteers. PP-001 has the potential to overcome off-target side effects and safety issues associated with DHODH inhibitors, with greater specificity and best-in-class picomolar potency. We are excited about the potential benefits of PP-001 for patients with dry eye and a range of ocular surface and systemic diseases. Our clinical initiatives remain on track and we expect to report topline results by Q4 2021.”
The randomized, double-masked, placebo-controlled POC study will be conducted at a site in Vienna, Austria and is designed to evaluate the safety, tolerability and efficacy of PP-001 in patients with ocular surface inflammation due to dry eye disease. A total of 21 patients will receive 0.15% of PP-001 or placebo for 12 days. The outcome of this study will guide the U.S. clinical development program for dry eye disease following the filing of the IND, which is expected in Q4 2021.
About PP-001
PP-001 is a novel, non-steroidal immunomodulatory small molecule. PP-001 is a highly specific nanomolar potent inhibitor of DHODH, an essential enzyme of the de novo pyrimidine pathway. Inhibition of this pathway also downregulates expression of IFN-γ and IL-17, two hallmark cytokines of Th1 and Th17 cells responsible for inflammatory diseases of the eye. Further, PP-001 reduces the host cell pyrimidine pool, which leads to inhibition of replication of activated immune cells.