→ A pivotal trial disaster has caught Faron Pharmaceuticals’ execs by surprise and crushed its stock. The Finnish biotech reported Tuesday that its lead drug, Traumakine, failed to meet the primary composite endpoint for efficacy in a Phase III trial for acute respiratory distress syndrome (ARDS). Immediately after the announcement, their shares $FARN slid 83% on the London Stock Exchange.
By the numbers, Traumakine actually did a little worse than placebo on all three counts of efficacy, though Faron pointed out that none of the differences were statistically significant. In the 300-person trial, by Day 28, patients treated with Traumakine had a medium of 10 ventilator free days, while the placebo group saw 8.5; all cause mortality at Day 28 was 26.4% those on Traumakine and 23% those given placebo; and mortality at Day 90 was 32.6% in the drug group compared to 31.6% in the placebo arm.
While disappointed, Faron CEO Markku Jalkanen stopped short of dismissing the drug entirely. With the European data in hand, the company will wait until the results of another PhIII study in Japan come out in Q3 to assess Traumakine’s future in the clinic. In his words: “We need to further analyse the data in order to understand how this study differs from our previous positive results with ARDS patients, both in terms of Traumakine’s efficacy, and in the unusually low mortality rate observed in the placebo arm.”
Regardless, he added, Faron will continue to develop solid cancer drug Clevegen, the next asset in the pipeline, with plans to initiate clinical development later this year.
→ There’s another big change in the works inside the executive suite at GlaxoSmithKline. CFO Simon Dingemans is in transition, with plans to leave the pharma giant next year. That gives GSK plenty of time to consider a successor to Dingemans as new CEO Emma Walmsley completes a makeover in the leadership group.
→ Cupertino-based drugmaker Durect Corp. is amending its deal with Novartis’ Sandoz unit on a development and commercialization agreement regarding Durect’s investigational drug Posimir. Under the original deal, Durect got a $20 million upfront payment, and was eligible for $43 million in development and regulatory milestones and up to $230 million in sales milestones and royalties. The amended agreement has Durect eligible for only $30 million in milestones triggered by FDA approval (sales milestones are unchanged). Both companies are permitted to develop and commercialize competing products and either party may terminate the contract for convenience, according to Durect’s news release.
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