SOV Therapeutics, a drug company formed in 2009 and based in Morrisville, has received orphan drug status from the FDA for its proposed testosterone treatment targeting boys who are afflicted with constitutional delay of growth and puberty.
The condition is known as CDGP and affects some 100,000 adolescents ages 14 to 17 in the U.S., SOV notes.
The SOV treatment would be administered orally.
SOV plans to advance the treatment to clinical trials.
Orphan drug status, which is granted to therapies treating diseases or disorders affecting fewer than 200,000 people, grants SOV certain tax incentives, fee waivers, eligibility for expedited review and seven years of market exclusivity if approved.
“Receiving Orphan Drug Designation by the FDA is an important milestone for SOV Therapeutics, as well as for adolescent boys with CDGP and we look forward to advancing our unique formulation into clinical trials in this patient population,” said Dr. Om Dhingra, SOV’s chief executive officer. “Current treatment options for these conditions are limited and we believe that the availability of an oral form of testosterone replacement therapy could offer significant advantages for patients and their families,” said Dr Alan Rogol, Professor Emeritus of Pediatric Endocrinology at the University of Virginia Medical Center and an advisor to SOV Therapeutics.
