Yuyu Pharma Announces Topline Results from the ICECAP Phase 1/2 Trial of YP-P10 in Dry Eye Disease
Yuyu Pharma announced topline results from the ICECAP phase 1/2 trial of YP-P10 in patients with dry eye disease. ICECAP was the first human, signal-seeking, phase 1/2 trial evaluating the safety and efficacy of YP-P10 over 12 weeks (85 days) of treatment in subjects with dry eye disease, according to a company news release.
The randomized, placebo-controlled, double-masked trial enrolled 257 patients across seven clinical sites in the United States. Enrolled patients were randomized 1:1:1 to receive topically administered YP-P10 0.3%, YP-P10 1%, or placebo (vehicle) twice daily. In the trial, 90.6% of YP-P10 0.3% patients, 94.2% of YP-P10 1% patients, and 97.7% of placebo patients completed the study. YP-P10 presented a positive safety profile and was well tolerated across the study groups. Adverse events were generally mild and balanced across the study groups, and there were no drug-related serious adverse events.
Study results showed the total corneal fluorescein staining scores and the ocular discomfort scores, determined by the visual analog scale (VAS), were improved from the baseline at Visit 6 (Day 85) in all three groups. However, the primary analysis of ANOVA models in the intent-to-treat (ITT) population showed that there were no statistically significant differences in the reduction from the baseline in the total corneal fluorescein staining scores or VAS scores at Visit 6 between groups.
“We had hoped for a different outcome but are encouraged that YP-P10 demonstrated trends in secondary outcomes with a favorable ocular safety profile,” Robert Yu, CEO of Yuyu Pharma, said in a company news release. “We will use the data, and our ongoing collaboration with scientific and clinical advisors, to design our next clinical trial. In the meantime, we would like to thank the study participants, clinical investigators, and the site coordinators for their participation in the trial.”
During analysis, trends were observed favoring YP-P10 1% and 0.3% in unanesthetized Schirmer’s tear test score on Day 15. With the onset of currently approved dry eye therapies ranging up to 6 months, faster-acting therapy would be a meaningful advancement for patients. Improvements in symptoms of ocular dryness and itching were also observed, which could lead to better patient compliance.
Yuyu will continue further analyses of the data to better understand the overall profile of YP-P10 in dry eye patients and decide the next steps for YP-P10.