Shire plc (SHPG - Free Report) recently enrolled the first patients for two phase II studies of its candidate SRM003 (formerly Vascugel), which is being developed for treating patients suffering from end-stage renal disease (ESRD). The patients are undergoing arteriovenous access creation for hemodialysis.
We note that SRM003 is being developed by Shire for its Regenerative Medicine (RM) business. The company obtained the rights to the candidate following its acquisition of Pervasis Therapeutics in Apr 2012.
AVF01-SRM003, the first of the two phase II studies, is designed to evaluate the efficacy and safety of SRM003 in improving the rate of arteriovenous fistula (AVF) maturation. In addition, it will also be evaluated for usage in patients with ESRD who are undergoing surgery for the creation of an AVF to aid hemodialysis access.
AVG01-SRM003, the second study, will evaluate the efficacy and safety of SRM003 for extending the duration of primary patency after placement of an arteriovenous graft (AVG) in ESRD patients.
SRM003 has been granted orphan drug designation in the US and the EU. In addition, SRM003 has received a Fast Track designation from the US Food and Drug Administration (FDA).
Diabetes is the root cause of ESRD. Shire aims to develop SRM003 to help patients suffering from diabetes.
Successful development and commercialization of SRM003 would boost the top line at Shire significantly since the diabetes market offers great commercial potential. We remind investors that Shire’s Regenerative Medicine business already has Dermagraft in its portfolio. The product is approved for the treatment of diabetic foot ulcers in the US, Canada, Mexico, Israel, and Malaysia.
Shire currently carries a Zacks Rank #3 (Hold). Pharma stocks, which currently look better placed include Novo Nordisk (NVO - Free Report) , Furiex Pharmaceuticals Ltd. , and Avanir Pharmaceuticals Inc .