Jeffrey L. Cleland, PhD, Chief Executive Officer of Versartis, Inc. (VSAR) [NO EXCHANGE], said the company would focus on expanding opportunities for its lead compound at the Canaccord Genuity 34th Annual Growth Conference at the Intercontinental Hotel in Boston.
Versartis Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a long-acting form of recombinant human growth hormone that’s designed for the treatment of growth hormone deficiency (GHD). VRS-317 will require significantly fewer injections for patients, potentially improving compliance and treatment outcomes, he said.
The company recently completed a Phase IIa clinical trial evaluating weekly, semi-monthly, and monthly dosing regimens of VRS-317 in children with GHD. Cleland said there is a potential $3 billion market for growth hormones, anticipated to grow to $4 billion by 2018.
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“Growth hormone deficiency is a specialized field,” Cleland said, noting that the disease is chronic and currently must be treated with daily injections. “Children who do take therapy, 2/3rds are non-compliant in injections.” Since VRS-317 requires fewer injections, Cleland anticipates patients will be more compliant and achieve better growth results.
Both pediatric and adult GHD are orphaned. VRS-317 is a fusion protein consisting of rhGH and a proprietary half-life extension technology known as XTEN, which is in-licensed from Amunix Operating, Inc. Amunix has granted Versartis a worldwide exclusive license for a 1% licensing fee under its patents and know-how related to the XTEN technology to develop and commercialize VRS-317 as well as another undisclosed XTEN-based product. There is patent protection until at least 2030.
Cleland said Versartis Inc.’s market is split across EU, U.S. and Japan. “We are pursuing development in all three of those territories,” he said, with the pediatric focus on U.S. and Europe.
October should see news on the Phase III study, Cleland said.
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