EyeGate Pharma Announces First Patient Dosed for PP-001 in a Phase 2 Proof-of-Concept Ocular Surface Inflammation Study
- Proof-of-concept study conducted in Austria-
-Topline data expected in Q4 2021-
WALTHAM, Mass., June 14, 2021 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG), ("EyeGate" or the "Company"), a clinical-stage company developing and commercializing products for treating inflammatory and immune diseases with a focus on the eye and certain systemic diseases, today announced the first patient dosed in phase II proof-of-concept ("POC") 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," said Franz Obermayr, Ph.D., Acting Chief Executive Officer of EyeGate. "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.
About EyeGate
EyeGate is a clinical-stage pharmaceutical company developing and commercializing products for treating inflammatory and immune diseases with a focus on the eye and certain systemic diseases. PP-001, EyeGate's lead clinical-stage drug product, is a next-generation, non-steroidal, immuno-modulatory and small-molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues associated with DHODH inhibitors. PP-001 has been developed in multiple clinical-stage formulations including ophthalmic and intravenous routes of administration. The ophthalmic formulation is in development for dry eye disease and conjunctivitis. In addition, EyeGate is developing Ocular Bandage Gel ("OBG"), a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve ocular surface integrity. OBG, with unique properties that help hydrate and protect the ocular surface, is in clinical evaluation for patients with punctate epitheliopathies ("PE") as a result of dry eye. For more information, please visit www.EyeGatePharma.com.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate's products, including EyeGate's PP-001 and OBG products, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading "Risk Factors" contained in EyeGate's Annual Report on Form 10-K filed with the SEC on March 25, 2021 or described in EyeGate's other public filings. EyeGate's results may also be affected by factors of which EyeGate is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
[email protected]
