Will further FDA discussions lead to approval for Motif Bio’s antibiotic Iclaprim?
, the clinical-stage biopharmaceutical company, discussed in a conference call with analysts the details of the Complete Response Letter (CRL) it received from the U.S. Food & Drug Administration (FDA).
The FDA has told Motif Bio that it is willing to have a meeting to discuss the CRL regarding the iclaprim New Drug Application (NDA). The drug is responsible for treating acute bacterial skin and skin structure infections (ABSSSI), but the FDA stated it could not approve the NDA in its present form.
By way of background, Iclaprim is designed to be effective against serious and life-threatening infections caused by multi-drug resistant Gram-positive bacteria, including MRSA (known as “superbugs”). Data indicates that it has a low propensity for resistance development and favourable tolerability profile.
In a conference call to investors and analysts, Motif Bio confirmed that the FDA had no questions over the clinical efficacy of Iclaprim. However the FDA stated it needs additional data to further evaluate the risk for liver toxicity before the NDA approval.
Shares in Motif Bio have fallen dramatically from 40p after the disclosure of the response from the FDA, but closed 8% higher following a conference call with investors and analysts.
Graham Lumsden, Chief Executive Officer of Motif Bio, said: "We are disappointed for patients and providers seeking an alternative antibiotic to treat ABSSSI.” However, he added: “We look forward to working with the Agency to discuss options to advance iclaprim towards approval."
On the conference call, questions were asked regarding iclaprim liver toxicity trials, specifically if the levels of liver toxicity were “physiologically meaningful”. Motif Bio highlighted the data from its clinical REVIVE trials which compared liver toxicity to Vancomycin. Vancomycin is an FDA approved drug, which also treats serious skin infections from bacteria that is unresponsive to other antibiotics.
In REVIVE-1 trials, 5.5% of patients in the iclaprim group, and 3.8% of patients in the vancomycin group, had elevated levels of aminotransferase (AST). AST and ALT are biomarker tests for measures of liver toxicity. REVIVE-2 trials revealed that 3.7% of patients in iclaprim, and 3% of patients in vancomycin, had elevated levels of AST.
A pooled analysis of both REVIVE-1 and REVIVE-2 looked at combined terms for AST and ALT. It was found that 2% of patients using iclaprim, and 2% of patients using vancomycin had elevated levels of AST. Interestingly, only 1.9% of patients in the iclaprim group and 2% of patients in the vancomycin group had elevated levels of ALT.
The company did not comment on questions regarding the impact that the US government shutdown may have had on the FDA’s decision making process.
It did confirm that the FDA gave no indication that it does not consider iclaprim to not be an approvable drug under FDA standards. It cited that the federal regulatory agency has agreed to meet Motif Bio.
Motif Bio did however state that a meeting with FDA usually takes 30-45 days to confirm a date, and therefore could not provide certainty over whether it had the funds available to reach the date.
Lender Hercules Capital, made an amendment to its loan agreement where Motif Bio is to make an early repayment of $7 million and a further $0.5 million. The alternative is the receipt of funds from an equity raise of $2 million or greater. The lender agreed to waive any applicable prepayment charges.
Motif Bio told investors it agreed to this amendment in order to “avoid unilateral action“ by Hercules. The company told investors that it intends to aggressively manage its existing funds and will need to raise capital in the near term.
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