Yuyu Pharma, Inc. announced topline results from a phase 1/2 trial assessing YP-P10 or the treatment of dry eye disease (DED).
Give me some company background.
Based in Seoul, South Korea, Yuyu Pharma is a global pharmaceutical company developing therapeutics in ophthalmology, neurology, dermatology, and urology.
Talk about YP-P10.
YP-P10 is a novel, patented synthetic peptide containing anti-inflammatory properties that may provide treatment for DED.
The ophthalmic solution received clearance from the FDA in April 2022 for its investigational new drug (IND) application—enabling Yuyu to launch its phase 2 clinical study.
Tell me about this study.
As Yuyu’s first biopharmaceutical clinical trials in the U.S., the multicenter, randomized, placebo-controlled, double-masked phase 1/2 ICECAP study (NCT05467293) is also the first-in-human trial of YP-P10.
And the dosages?
A total of 257 patients with DED were randomized 1:1:1 to receive one of three treatments, administered topically:
- 0.3% YP-P10: 1 drop twice daily (BID) in each eye (n = 80)
- 1% YP-P10: 1 drop BID in each eye (n = 80)
- Placebo (vehicle): 1 drop BID in each eye (n = 80)
What was the goal?
Investigators sought to compare the safety and efficacy of YP-P10 to a placebo for DED treatment; their hypothesis was that 0.3% YP-P10 and 1% YP-P10 would be superior to a placebo for treating DED.
What was measured?
The primary outcome measures—by Day 85 of the study—included total corneal fluorescein staining (CFS) score of the study eye (using a modified National Eye Institute [NEI] scale) and the ocular discomfort score of both eyes using the visual analog scale (VAS).
See here for secondary outcome measures.
And the findings?
Out of the 270 enrolled patients, 90.6% (0.3% YP-P10 group); 94.2% (1% YP-P10 group); and 97.7 (placebo group) completed the trial.
Generally speaking, YP-P10 exhibited a favorable safety profile and was well-tolerated across all three groups, with no reports of drug-related serious adverse events.
However, both the primary and secondary endpoints were not met.
Give me more.
The CFS and ocular discomfort scores (determined via VAS) improved from baseline to Day 85 for all groups.
Conversely, the company noted that the ANOVA models for the intent-to-treat (ITT) population showed no statistically significant differences for the reduction from baseline in the total CFS or VAS scores between the groups.
Is that it?
Of special note: both 0.3% and 1% YP-P10 exhibited encouraging trends in unanesthetized Schirmer’s tear test score on Day 15—translating potential for a faster rapid-acting dry eye therapy than current treatments (up to 6 months).
Further, ocular dryness and itching symptom improvements were observed.
What did Yuyu have to say about the data?
While the company had hoped for a different outcome, Yuyu CEO Robert Yu stated that the trends YP-P10 demonstrated for secondary outcomes with a favorable ocular safety profile.“We will use the data, and our ongoing collaboration with scientific and clinical advisors, to design our next clinical trial,” he stated.