YP-P10 / Yuyu Pharma - LARVOL DELTA

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1) (clinicaltrials.gov) - P2 | N=257 | Completed | Sponsor: Yuyu Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Anti-inflammatory effect of YP-P10: upregulation of CD25, FoxP3 and TGFβ/IL-10 co-expression in Behçet's patients' blood-derived CD4+T cells and downregulation of il-17f and ifng genes by Th17 cells (ARVO 2024) - "YP-P10 exerts an anti-inflammatory effect on stimulated healthy and patient-derived CD4+T cells by downregulating pro-inflammatory cytokines and upregulating Treg-associated cytokines at the protein and RNA levels.1Calder et al (2023) ARVO abstract 'YP-P10 Peptide selectively decreased Th2 and Th17 cells in an in vitro model of human blood-derived effector CD4+T-cell subsets'"

Clinical • IO biomarker • Dry Eye Disease • Ophthalmology • CD4 • CD8 • CTLA4 • FOXP3 • IFNG • IL10 • IL2RA • ISG20 • TGFB1 • TGFBR2

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1) (clinicaltrials.gov) - P2 | N=257 | Active, not recruiting | Sponsor: Yuyu Pharma, Inc. | Trial completion date: Mar 2023 ➔ Aug 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Yuyu Pharma unveils phase 1/2 trial of dry eye pipeline in the US [Google translation] (Medical News) - "Yuyu Pharmaceutical's multicenter, randomized, double-blind, placebo-controlled clinical trial of 'YP-P10', a dry eye treatment in the United States, involving 257 patients at 7 hospitals in the United States. Announced the results of phase 1/2 trials...the primary evaluation index, TCSS (Total Corneal Fluorescein Staining Scores) and ODS (Ocular Discomfort Scores, ocular discomfort) improved. However, there was no statistically significant difference compared to the placebo group....YP-P10 increased tear secretion 15 days after administration in the Schirmer test, one of the secondary evaluation indicators, and showed a statistically significant improvement (1.0% p=0.029, 0.3% p=0.013) compared to placebo....'we confirmed positive data on the safety and excellent tolerability of YP-P10, and it is significant that no serious adverse reactions were found,'..."

P1/2 data • Dry Eye Disease • Ophthalmology

YP-P10 Peptide selectively decreased Th2 and Th17 cells in an in vitro model of human blood-derived effector CD4+T-cell subsets. (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Dry Eye Disease • Ophthalmology • CD19 • CD4 • CD8 • IL17A • IL1B • IL23A • IL4 • IL6

Novel YP-P10 Peptide reduces corneal damage in a mouse dry eye model compared with Lifitegrast, Cyclosporine, Diquafosol sodium and Hyaluronic acid. (ARVO 2023) - "Consequently there is unmet need for additional well tolerated therapies with rapid onset of action to treat both, signs and symptoms of dry eye. The research described is an attempt to address the unmet need."

Preclinical • Corneal Abrasion • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1) (clinicaltrials.gov) - P2 | N=257 | Active, not recruiting | Sponsor: Yuyu Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1) (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Yuyu Pharma, Inc.

New P2 trial • Dry Eye Disease • Ophthalmology