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news.Clinical Data has announced that it is progressing with its phase III study of vilazodone in depression, with patient enrolment now over one third complete. The company also revealed that its subsidiary has agreed a deal to manufacture vilazodone under a license agreement with Merck KGaA.
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Clinical Data announced that over 150 patients have now been enrolled in the company’s phase III clinical study of vilazodone. The trial is being conducted as a double-blind, placebo-controlled study designed to assess the safety and efficacy of vilazodone for the treatment of depression.
The trial will enroll approximately 400 adult patients diagnosed with major depressive disorder at nine US centers. As part of the trial, Clinical Data will also seek to discover genetic markers for response to vilazodone.
Separately, the company announced that its wholly-owned subsidiary, Genaissance Pharmaceuticals, has exercised its contractual rights with Merck KGaA to assume the manufacturing technology necessary to produce a commercial supply of vilazodone. This will trigger a milestone payment to the German firm, which will be paid in equity in Clinical Data equivalent in value to E1.25 million ($1.6 million).
Clinical Data also announced that it has met voluntarily with representatives of the FDA to discuss the status of its vilazodone development program, including its plans to manufacture vilazodone and to obtain agreement with FDA staff on certain aspects of the requirements for new drug application (NDA) filing related to both manufacturing processes and the clinical program. The company said that these goals were accomplished.