Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KB803 · 1 trial · 4 indications
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Average number of days per month with corneal abrasion symptoms.
| Arm | Type | Description |
|---|---|---|
| KB803 | EXPERIMENTAL | KB803 |
| Placebo | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| KB803 | BIOLOGICAL | Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein |
| Placebo | DRUG | Vehicle |
Inclusion Criteria: 1. The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and instructions. 2. Age 6 months or older at time of informed consent/assent. 3. Confirmed diagnosis of DEB with a mutation in the C...
KB803 is an investigational monoclonal antibody being developed for the treatment of Dystrophic Epidermolysis Bullosa (DEB), a rare genetic skin disorder. It is currently being studied in patients with recessive and dominant forms of the disease, including children as young as 6 months old.
KB803 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol KRYS. The company is conducting a Phase 3 clinical trial of KB803 in the United States.
KB803 is currently in Phase 3 clinical development. It is being evaluated in a randomized, double-blind, placebo-controlled study (NCT07016750) that is actively recruiting patients with Dystrophic Epidermolysis Bullosa. The drug is investigational and has not been approved by regulatory authorities.
KB803 is being studied in a single Phase 3 clinical trial with the identifier NCT07016750. This trial is titled "A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa" and is currently recruiting participants in the United States.
KB803 is a monoclonal antibody, a type of drug designed to bind to a specific protein in the body. However, the exact molecular target of KB803 has not been disclosed in available information. Its mechanism of action in treating Dystrophic Epidermolysis Bullosa is therefore not publicly detailed.