{"id":"kb803","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site reactions"},{"rate":null,"effect":"Infection at treatment site"},{"rate":null,"effect":"Scarring or fibrosis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KB803 uses an ex vivo approach where patient fibroblasts are transduced with a modified adeno-associated virus (AAV) carrying the COL7A1 gene, then reintroduced into the skin to produce functional type VII collagen. This addresses the underlying genetic defect in recessive dystrophic epidermolysis bullosa (RDEB), a severe blistering disorder caused by mutations in the COL7A1 gene that encodes collagen VII.","oneSentence":"KB803 is a gene therapy that delivers a functional COL7A1 gene to restore type VII collagen production in patients with recessive dystrophic epidermolysis bullosa.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:47:36.761Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Recessive dystrophic epidermolysis bullosa (RDEB)"}]},"trialDetails":[{"nctId":"NCT07016750","phase":"PHASE3","title":"A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa","status":"RECRUITING","sponsor":"Krystal Biotech, Inc.","startDate":"2025-06-20","conditions":"Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"KB803","genericName":"KB803","companyName":"Krystal Biotech, Inc.","companyId":"krystal-biotech-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"KB803 is a gene therapy that delivers a functional COL7A1 gene to restore type VII collagen production in patients with recessive dystrophic epidermolysis bullosa. Used for Recessive dystrophic epidermolysis bullosa (RDEB).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}