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Dynavax initiates PhIII study it hopes will quell FDA's safety concerns

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Regulatory decisions have battered shares of Dynavax Technologies ($DVAX) over the past year and a half. FDA and EMA requests for more data on hepatitis B candidate Heplisav have set the Berkeley, CA-based company back time and again. Now, Dynavax is embarking on a new trial it hopes will address some of those safety concerns.

On Tuesday, Dynavax announced the initiation of a Phase III study designed to evaluate Heplisav's overall safety, with a coprimary objective of demonstrating noninferiority compared with GlaxoSmithKline's ($GSK) hep B jab Engerix-B in Type 2 diabetes patients. Researchers will conduct the observer-blinded trial at about 40 sites across the U.S., the company said.

Dynavax fashioned the trial, dubbed HBV-23, to address a Complete Response Letter the FDA sent over last February, in which it stressed that the company would need more safety data in order to grab approval in its intended age range of 18-70. In that letter, the agency also echoed concerns first brought up by an advisory panel in November 2012, which voted down the jab on worries that its novel adjuvant could cause autoimmune disorders.

But the FDA hasn't been the only regulatory body to hold Heplisav up; just two months ago, the EMA put in its own request for more safety info, driving Dynavax to withdraw its European application while it works to generate the data.

The new trial will satisfy both agencies' needs for data, Dynavax hopes; the company expects about 8,250 adults between the ages of 18 and 70 to enroll by the end of 2014, with all follow-up wrapped by the end of 2015. And if it does, a payoff could be in store: Though jabs from Glaxo, Sanofi ($SNY) and Merck ($MRK) dominate the market, research firm GlobalData recently forecasted peak sales of Heplisav at $85 million.

- read the release

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