Yuyu Pharma Announces First Patient Enrolled in Phase 2 Study of YP-P10 Ophthalmic Solution for the Treatment of Dry Eye Disease

Yuyu Pharma announced the enrollment of the first patient in a phase 2 clinical study evaluating YP-P10, a novel and patented synthetic peptide with anti-inflammatory and wound healing properties being investigated to treat patients with dry eye disease (DED).

Yuyu received clearance in April 2022 from the FDA for its investigational new drug application (IND) for YP-P10. This clearance enabled Yuyu to initiate the phase 2 clinical study, named ICECAP (randomIzed plaCebo EffiCacy sAfety yP-p10), to evaluate the safety, tolerability, and efficacy of YP-P10 for DED. The study will be conducted in the United States at seven sites with 240 patients.

“We are pleased to enroll our first patient in ICECAP 1, the phase 2 clinical study of YP- P10 ophthalmic solution,” Robert Yu, CEO of Yuyu Pharma, said in a company news release. “This is our first biopharmaceutical clinical trial within the United States, and we are enthusiastic about its potential to assist patients with DED who struggle to find lasting relief with alternative therapies currently available in the market.”

Developed by Yuyu Pharma R&D, YP-P10 has the potential to provide more relief to patients with DED. Preclinical data [3] show that YP-P10 was a more active immunomodulator than lifitegrast in lowering pro-inflammatory cytokines and chemokines production in human peripheral blood mononuclear cells (PBMCs) when stimulated by lipopolysaccharide (LPS), according to Yuyu Pharma.

Additional studies in dry eye animal models have shown that there are dose-dependent decreases in several dry eye-associated inflammatory mediators and improvement in corneal damage. These findings indicate that YP-P10 has corticosteroid-like anti-inflammatory activity on dry eye-induced ocular surface inflammation.

"Dry eye disease has remained a challenge for patients, and management conundrum for eye care professionals despite the approval of multiple therapeutic options,” said Francis Mah, MD, Director of Cornea Services at Scripps Clinic. “A new therapeutic option with a more potent immunomodulatory effect is of great interest, and I look forward to seeing how YP-P10 performs in the clinic.”