Keystone Biologics develops effective and potentially safer biological therapies for patient populations who need treatments that work without significant side effects. Our first drug product candidate targets ulcerative colitis.
Primary Product Candidate
kPPF1 for Ulcerative Colitis
Keystone Biologics has identified a biologic protein that has great potential to alleviate symptoms in moderate to severe ulcerative colitis. This drug is being developed as a therapy to prevent colorectal surgery or the use of high doses of intravenous steroids. Preliminary research indicates that the biologic derived from human plasma will be safer while providing the same if not better efficacy.
This drug product candidate is in pre-clinical development. Keystone Biologics has applied for Orphan Product* status; the application is open and under review. A recent non-clinical study resulted in a definitive proof of concept for the product candidate (complete study data will be forthcoming). An Investigational New Drug (IND) application submission is planned for Q3 2011. Once accepted, Keystone Biologics targets Phase I clinical trials to initiate in early 2012.
For more information about the Keystone Biologics product pipeline, contact us.
*What is an orphan drug?
An orphan drug is one that is used in rare diseases that have a prevalence of 200,000 patients or less. A product with this designation is offered seven years of marketing exclusivity and once approved, would provide Keystone the opportunity to offer patients this new treatment.