Vasopharm has emerged from talks with investors armed with €20 million ($22 million) to hustle its treatment for traumatic brain injury (TBI) through Phase III. The funding gives vasopharm renewed momentum after a period in which its lead candidate was stuck between trials for several years.
Wuerzburg, Germany-based vasopharm wrapped up a Phase IIa trial of the drug, VAS203, back in 2012, before going on to raise €5 million for further development and agree on the key elements of a pivotal trial with the European Medicines Agency (EMA) the following year. However, after releasing details of the EMA agreement on the Phase III trial design in October 2013, vasopharm went quiet. That changed this week when the company emerged from its 27-month silence with details of a €20 million investment.
Financial and business development matters have occupied vasopharm, an 8-person virtual biotech, in the intervening months. "Once we had the Phase III protocol in place we entered serious discussions and due diligence with a number of potential parties but decided not to sign an agreement at this time," vasopharm Chairman Andrew Clark told FierceBiotech. "We also planned to raise equity finance which would allow us to complete the trial in Europe ourselves. All of which took time as we would not start the trial without raising the finance."
Existing investors Entrepreneurs Fund and Heidelberg Capital Private Equity co-led the round with support from a new backer, Fort Rock Capital. The financiers' willingness to cough up the cash means vasopharm is now set to see if VAS203 can live up to the promise it showed earlier in development. In a 32-person Phase IIa trial, none of the patients who received VAS203, an allosteric nitric oxide synthase, alongside standard of care died. The mortality rate in the placebo arm was 12.5%. VAS203 is thought to improve outcomes in TBI by preventing the harmful buildup of intracranial pressure.
The goal now is to show that this hypothesis holds up to the scrutiny of a late-phase trial. Having put all of the groundwork for the study in place over the past year, vasopharm is aiming to start the first patient in the trial during the next 6 months. The goal of the trial is to deliver data that will enable vasopharm to secure approval for the drug in Europe as a treatment for moderate to severe TBI. In working toward this goal, vasopharm has looked at the issues others in the field have encountered and designed its trial accordingly.
"We were very conscious that trial design is absolutely key to being able to demonstrate the action of a drug and that in this indication we felt that some previous studies had errors in design we were determined not to replicate," Clark said. "We wanted to design the Phase III study ourselves, certainly for Europe, because we know more about our drug than anyone else."
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