Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KB111 · 1 trial · 3 indications
Number of subjects with treatment related adverse events as assessed by CTCAE v5
| Arm | Type | Description |
|---|---|---|
| KB111 | EXPERIMENTAL | KB111 |
| Name | Type | Description |
|---|---|---|
| KB111 | BIOLOGICAL | KB111 is a replication-defective, non-integrating herpes simplex virus (HSV-1)-based vector encoding functional, full-length human ATP2C1 protein combined with a gel for topical application. |
Inclusion Criteria: * The participant 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 * Aged ≥ 12 years of age at the time of informed consent/assent * Documented...
KB111 is an investigational monoclonal antibody being developed for the treatment of Hailey Hailey Disease, a rare genetic skin disorder. It is designed to address the skin lesions associated with the condition. KB111 is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.
KB111 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KRYS. The company is conducting clinical trials to evaluate the safety and efficacy of KB111 for the treatment of Hailey Hailey Disease.
KB111 is in Phase 1 clinical development. It is currently being studied in an early Phase 1 trial that is recruiting participants. The drug is investigational and has not received regulatory approval. It has been granted Fast Track designation by the FDA, which may expedite its development and review.
KB111 is being evaluated in a single clinical trial registered as NCT07717346, titled "A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease." This early Phase 1 study is recruiting participants in the United States and aims to enroll 7 individuals aged 12 years and older.
No, KB111 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted KB111 Fast Track designation, which is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.