Yuyu Pharma announces 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 to treat patients with dry eye disease (DED).

 

As part of its ongoing commitment to global expansion and continuous innovation, Yuyu received clearance in April 2022 from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug Application (IND) for YP-P10 Ophthalmic Solution.

 

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 to help advance the treatment of patients with 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," said Robert Yu, CEO of Yuyu Pharma. "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."

 

Despite the availability of therapeutic options for nearly 20 years, DED remains a persistent and challenging condition to treat. The prevalence of DED ranges from 5% to 50% of the population, affecting women much more frequently than men.1Results from a survey of 415 U.S.-based patients with DED showed that almost half (48%) of respondents said they followed their treatment plan carefully, but only 13% experienced lasting relief.2

 

Developed by Yuyu Pharma R&D, YP-P10 Ophthalmic Solution has the potential to provide more relief to patients with DED. Preclinical data 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).3

 

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."