For Motif Bio, 2019 was going to be all about the launch and rollout of iclaprim. But a complete response letter from the FDA has shattered that dream and sent its stock crashing.
This is the second time regulators have said no to the antibiotic. The first rejection took place in 2009, when iclaprim was in the hands of a Roche spinout named Arpida, as experts expressed concern about QT prolongation and a disproportionate number of deaths, while pointing to murky efficacy.
Motif Bio, which ended up picking up the drug, has since run two Phase III trials demonstrating iclaprim’s non-inferiority compared to vancomycin among patients with acute bacterial skin and skin structure infections.
The FDA, however, remains leery about the safety profile and are now requesting additional data to further evaluate the risk for liver toxicity, the company said.
“We intend to request a meeting with the FDA, which typically should occur within approximately 30-45 days, to discuss the CRL,” CEO Graham Lumsden said in a statement.
When reached for comment, the company declined to elaborate on the nature of regulators’ concern, or how long it might take to resubmit an NDA. It did, however, disclose in its press release that it had $12.3 million in cash and $15 million of debt at the end of last year — adding that it will need to raise capital soon before the money runs out in the second quarter.
Motif Bio’s shares on the Nasdaq $MTFB took a 76% descent pre-market, wiping out all its gains — and more — from a slow climb that started in December.
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