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 therapy being developed for the treatment of Hailey Hailey Disease, a rare genetic skin disorder. It is designed to address the underlying cause of the condition, which leads to blistering and skin lesions. KB111 is currently in early clinical development and has not yet been approved by regulatory authorities.
KB111 targets ATP2C1, a protein involved in calcium transport within cells. Mutations in the ATP2C1 gene are responsible for Hailey Hailey Disease. By targeting this molecular pathway, KB111 aims to correct the cellular dysfunction that causes the skin symptoms associated with the disease.
KB111 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KRYS. The company is conducting clinical research 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 trial that is recruiting participants. The drug has received Fast Track designation from the FDA, which is intended to expedite its development and review process, but it remains investigational and is not yet approved.
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 approximately 7 participants in the United States and is not randomized or blinded.