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KIO-104 · 1 trial · 1 indication
The primary objective is safety and tolerability. The incidence of AEs will be presented by System Organ Class (SOC) and Preferred Term (PT) by dose cohorts.
| Arm | Type | Description |
|---|---|---|
| Low Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| High Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| Low or High Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| Low or High Dose KIO-104: 4-weekly | EXPERIMENTAL | 4-weekly dosing |
| Name | Type | Description |
|---|---|---|
| KIO-104 | DRUG | KIO-104 is an ophthalmic formulation for IVT injection of the active pharmaceutical ingredient (API) KIO-100, a novel, non-steroidal, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH). |
Inclusion Criteria: Participants must meet all the following criteria: 1. Be aged 18 to 85 years inclusive at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
KIO-104 is an investigational small molecule being developed for the treatment of macular edema, a condition characterized by fluid accumulation in the macula of the eye. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
KIO-104 targets dihydroorotate dehydrogenase (DHODH), an enzyme involved in pyrimidine biosynthesis. By inhibiting DHODH, KIO-104 may modulate immune and inflammatory responses implicated in the pathogenesis of macular edema.
KIO-104 is being developed by Kiora Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KPRX. The company is conducting clinical trials to evaluate the safety and efficacy of KIO-104 in patients with macular edema.
KIO-104 is currently in Phase 2 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 2 trial is recruiting participants to assess the safety, tolerability, and efficacy of intravitreal KIO-104 in patients with macular edema.
KIO-104 is being evaluated in a Phase 2 clinical trial with the identifier NCT06825702. This study, titled 'Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema,' is recruiting 28 participants in Australia. The trial is controlled but not randomized or double-blinded.