Krystal Biotech discloses single-patient KB801 data for patent filing
Krystal Biotech, Inc. filed a response to a U.S. Patent and Trademark Office action regarding its investigational gene therapy KB801 for neurotrophic keratitis. The response included previously undisclosed data from a single patient in a discontinued clinical study, showing complete closure of a persistent corneal epithelial defect. The company clarified that the study was discontinued to advance KB801 to a pivotal trial, with no safety concerns observed. This disclosure ensures equal access to information becoming public through the patent prosecution record, with the company emphasizing that this single-patient observation does not represent top-line results or allow conclusions on safety or efficacy.
Key Highlights
- Krystal Biotech responded to a patent office action for gene therapy KB801.
- Response included single-patient data from a discontinued clinical study.
- Patient showed complete closure of a persistent corneal epithelial defect.
- Study discontinued to advance KB801 to a pivotal trial, no safety concerns.
- Disclosure ensures equal access to information from patent prosecution record.
- Single-patient data does not represent top-line results or efficacy conclusions.
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