Yuyu Pharma has enrolled the first participant in a Phase II clinical study of YP-P10 Ophthalmic Solution to treat dry eye disease (DED).
YP-P10 is a new and patented synthetic peptide that has anti-inflammatory and wound healing properties which help in treating DED.
It was developed by Yuyu Pharma R&D and has the potential to provide more relief to DED patients.
In April this year, the US Food and Drug Administration (FDA) approved the company’s investigational new drug application (IND) for YP-P10.
The IND approval allowed the company to begin the Phase II study, dubbed as ICECAP (randomIzed plaCebo EffiCacy sAfety yP-p10).
The study has been designed to assess YP-P10’s efficacy, safety, and tolerability to help advance DED patients’ treatment.
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It is planned to be carried out at seven sites in the US with 240 participants.
Yuyu Pharma CEO Robert Yu said: “We are pleased to enrol our first patient in ICECAP 1, the Phase II clinical study of YP-P10 Ophthalmic Solution.
“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.”
The preclinical findings demonstrated that YP-P10 Ophthalmic Solution was a more active immunomodulator in reducing the production of pro-inflammatory cytokines and chemokines in human peripheral blood mononuclear cells (PBMCs) when stimulated by lipopolysaccharide (LPS) compared to lifitegrast.
As per the additional studies conducted in dry eye animal models, dose-dependent decreases were observed in several dry eye-associated inflammatory mediators and improves corneal damage.
These findings show that the company’s YP-P10 has corticosteroid-like anti-inflammatory activity on dry eye-induced ocular surface inflammation.