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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 being developed by Kiora Pharmaceuticals for ophthalmology indications, specifically non-infectious uveitis and keratoconjunctivitis. It is currently in Phase 1 clinical development and has not been approved by the FDA.
PP-001 is a small molecule therapeutic being developed for ocular diseases. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not fully characterized in public data.
PP-001 is being developed by Kiora Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KPRX. The company is focused on ophthalmic therapies.
PP-001 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with chronic non-infectious uveitis and another in healthy volunteers for keratoconjunctivitis. It remains investigational and is not FDA approved.
PP-001 has completed two Phase 1 trials. NCT03634475 evaluated intravitreal PP-001 in 12 patients with non-infectious uveitis across Austria, Belgium, Germany, Netherlands, and the UK. NCT03769454 studied PP-001 eye drops in 45 healthy volunteers in Austria for keratoconjunctivitis and ocular surface disease.
PP-001 is the primary name for this investigational compound. No alternative names have been reported in public clinical trial registries, so it is not known to be identical to any other marketed or investigational drug.