Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KB801 · 1 trial · 1 indication
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Proportion of subjects receiving KB801 exhibiting complete PCED closure at Week 8 compared to those receiving placebo.
| Arm | Type | Description |
|---|---|---|
| KB801 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| KB801 | BIOLOGICAL | Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF) |
| Placebo | DRUG | Vehicle |
Inclusion Criteria: 1. The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions. 2. Aged ≥ 18 years at the time of informed consent. 3. Diagnosis of Stage 2 or ...
KB801 is an investigational monoclonal antibody being developed for the treatment of neurotrophic keratitis, a degenerative corneal disease. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
KB801 targets HSV-1, the herpes simplex virus type 1, using a viral vector delivery system. The drug is designed to address the underlying viral cause of neurotrophic keratitis, a condition that affects the cornea of the eye.
KB801 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KRYS. The company is conducting clinical trials to evaluate the safety and efficacy of KB801 in patients with neurotrophic keratitis.
KB801 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the treatment's safety and preliminary efficacy.
KB801 is being evaluated in a Phase 1 clinical trial with the identifier NCT06999733. This randomized, double-blind, placebo-controlled study is recruiting approximately 60 patients with Stage 2 or 3 neurotrophic keratitis in the United States.
KB801 is a distinct investigational drug developed by Krystal Biotech. It is not known to be the same as any other approved or investigational medication. Its unique mechanism targets HSV-1 using a viral vector approach for the treatment of neurotrophic keratitis.