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PP-001 · 2 trials · 3 indications
To assess safety and tolerability of ascending, multiple daily doses of PP-001 eye drops in healthy, adult volunteers and in patients with ocular surface inflammation
| Arm | Type | Description |
|---|---|---|
| PP-001 verum - cohort 1 | EXPERIMENTAL | PP-001 verum - cohort 1 |
| Placebo - cohort 1 | PLACEBO_COMPARATOR | Placebo - cohort 1 |
| PP-001 verum - cohort 2 | EXPERIMENTAL | PP-001 verum - cohort 2 |
| Placebo - cohort 2 | PLACEBO_COMPARATOR | Placebo - cohort 2 |
| PP-001 verum - cohort 3 | EXPERIMENTAL | PP-001 verum - cohort 3 |
| Placebo - cohort 3 | PLACEBO_COMPARATOR | Placebo - cohort 3 |
| PP-001 verum - cohort 4 | EXPERIMENTAL | PP-001 verum - cohort 4 |
| Placebo - cohort 4 | PLACEBO_COMPARATOR | Placebo - cohort 4 |
| PP-001 | EXPERIMENTAL | Single intravitreal injection of 3 up to 4 doses of PP-001 |
| Name | Type | Description |
|---|---|---|
| PP-001 | DRUG | PP-001 eye drops |
| Placebo | OTHER | Placebo eye drops |
Inclusion Criteria (excerpt): Cohorts 1-3: * male or female healthy volunteers 18 - 64 years of age * good general state of health and participants must not have a diagnosis of any eye disease that could effect the pharmacokinetics of PP-001 Cohort 4: * male or female subjects 18-64 years of age...
PP-001 is an investigational small molecule developed by Kiora Pharmaceuticals, Inc. (ticker KPRX) for ophthalmology indications. It is being studied in keratoconjunctivitis and non-infectious uveitis. PP-001 is in Phase 1 clinical development and is not approved for any indication.
PP-001 targets DHODH, or dihydroorotate dehydrogenase, an enzyme. By acting on this enzyme target, PP-001 is designed as a small molecule therapeutic for ophthalmic conditions including keratoconjunctivitis and non-infectious uveitis.
PP-001 is being developed for keratoconjunctivitis and non-infectious uveitis, both ophthalmology conditions. It is an investigational therapy and has not been approved for these or any other uses. Clinical testing to date has focused on ocular surface disease and chronic non-infectious uveitis.
PP-001 is developed by Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX. The company is the sponsor of the clinical program evaluating PP-001 in ophthalmology indications, including keratoconjunctivitis and non-infectious uveitis.
PP-001 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The completed Phase 1 studies evaluated PP-001 eye drops in healthy adult volunteers and intravitreal PP-001 in patients with chronic, non-infectious uveitis.
PP-001 has been studied in two completed Phase 1 trials. NCT03769454 tested PP-001 eye drops in 45 healthy adult volunteers in Austria. NCT03634475 evaluated intravitreal PP-001 in 12 patients with chronic, non-infectious uveitis across Austria, Belgium, Germany, the Netherlands, and the United Kingdom.