Versartis (VSAR) Approves to Commence Somavaratan Phase 3 in Japan

October 17, 2016 9:02 AM EDT

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Amunix is pleased to announce that Versartis Inc. (Nasdaq: VSAR) has been granted approval in Japan by the PMDA to initiate enrollment for its Phase 3 study of somavaratan (XTENylated recombinant growth hormone) in pediatric patients with growth hormone deficiency (GHD).

Somavaratan is a long-acting version of growth hormone created using Amunix's XTEN technology under license to Versartis. Somavaratan's twice-monthly dosing schedule in pediatric patients is the least frequent dosing interval in development for long-acting growth hormones.

Versartis disclosed that the Phase 3 stage of the J14VR5 trial is a single-arm, multi-center trial evaluating the safety and efficacy of 3.5 mg/kg twice-monthly somavaratan, the same dose and regimen as the VELOCITY Phase 3 trial. Enrollment in the Phase 3 trial is expected to be completed in the third quarter of 2017, with topline data expected in 2018.

"The initiation of Phase 3 trials for somavaratan in Japan is great news and the continued progression of studies of XTENylated growth hormone in this important ex-US geography underscores the commitment on the part of the health authorities there towards such next generation therapies," said Volker Schellenberger, Amunix's Chief Executive Officer. "We are very encouraged by the sustained drive towards commercialization of somavaratan in all key geographies by Versartis."

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