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EyeGate Pharmaceuticals, Inc.'s lead product candidate is designed to treat dry eye disease-induced ocular surface inflammation.
EyeGate Pharmaceuticals, Inc. has dosed the first patient in a phase 2 proof-of-concept study of PP-001 for the treatment of ocular surface inflammation.
The company's lead product candiate, PP-001 is an immune-modulating molecule and an inhibitor of dihydroorotate dehydrogenase (DHODH), according to the company.
Per a company news release, the randomized, double-masked, placebo-controlled POC study is planned to be conducted in Vienna, Austria, with 21 participants.
The study will evaluate the safety, efficacy, and tolerability of PP-001 in patients who have dry eye disease (DED)-induced ocular surface inflammation.
Participants will receive either receive 0.15% of PP-001 or a placebo for 12 days.
“This study builds on encouraging preclinical data and on positive clinical safety data from a Phase 1 study in healthy volunteers," said Franz Obermayr, PhD, acting CEO EyeGate, in a company news release. "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."
Results from the study intend to provide guidance for the U.S. clinical development program for DED after filing of the IND, expected to be completed in the fourth quarter of 2021.