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 both recessive and dominant forms of the disease, including children as young as 6 months old.
KB803 targets COL7A1, which is the gene that encodes type VII collagen, a protein essential for anchoring the skin layers together. By targeting COL7A1, KB803 is designed to address the underlying cause of Dystrophic Epidermolysis Bullosa, where mutations in this gene lead to fragile skin that blisters easily.
KB803 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 KB803 in patients with Dystrophic Epidermolysis Bullosa.
KB803 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to compare KB803 against a matched placebo in patients with Dystrophic Epidermolysis Bullosa.
KB803 is being evaluated in a single Phase 3 clinical trial with the identifier NCT07016750. This randomized, double-blind, placebo-controlled study is recruiting 16 participants with Dystrophic Epidermolysis Bullosa in the United States. The trial is currently in the recruiting stage and is open to all sexes.