Shares of Versartis Inc. (VSAR) plunged over 83% in extended trading on Thursday, following disappointing results from its phase III study of Somavaratan, dubbed VELOCITY.
Somavaratan is an investigational, long-acting form of recombinant Human Growth Hormone to treat the orphan disease of Growth Hormone Deficiency, or GHD.
The VELOCITY trial enrolled 137 naïve to treatment, pre-pubertal children with GHD, and was designed to demonstrate non-inferiority of Somavaratan compared to Pfizer Inc.’s (PFE) Genotropin, a daily recombinant human growth hormone (rhGH) in pediatric growth hormone deficiency patients.
The height velocity at 12 months was set as the primary efficacy measure of the study, and it was not achieved by the study. The 12-month height velocity for the intent to treat (ITT) patients who received Somavaratan twice monthly was 9.44 cm, versus 10.70 cm for those receiving Genotropin daily.
Commenting on the trial results, Jay Shepard, President and CEO of Versartis, said, “We are very surprised and disappointed to learn the outcome of the VELOCITY trial. Somavaratan showed height velocity in the range we had hoped, but it was not sufficient to demonstrate non-inferiority in this trial. We have done an initial analysis of the top-line data and are continuing to thoroughly review the results to gain greater insight into the trial outcome. We plan to provide a corporate update later this year”.
A phase III trial of Somavaratan in pre-pubertal Japanese children with growth hormone deficiency is ongoing, and it is known by the name J14VR5 trial. Enrollment in this trial is expected to be completed during the second half of this year.
Somavaratan has also been tested in adults with GHD in a phase II trial. This study, known as VITAL, has helped the company identify a clear path for phase III trial of Somavaratan in adult GHD. Versartis is planning to initiate a phase III trial of Somavaratan in adult GHD by end of 2017.
Now that the VELOCITY study results have disappointed, it remains to be seen if any changes are going to be incorporated in the ongoing and pending Somavaratan trials.
VSAR closed Thursday’s trading at $21.60, down 1.14%. In after-hours, the stock plunged 83.80% to $3.50.
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by RTT Staff Writer
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