It's Déjà Vu For Motif Bio's Iclaprim

(RTTNews) - Shares of Motif Bio plc (MTFB) plunged as much as nearly 75% today to touch a new low of $2.61, following disappointing regulatory news.

The FDA has refused to approve the Company's Iclaprim for the proposed treatment of acute bacterial skin and skin structure infections (ABSSSI), and the Complete Response Letter issued states that additional data are needed to further evaluate the drug candidate's risk for liver toxicity before it could be approved.

This is not the first time that Iclaprim has been rejected by the FDA.

In 2009, when Iclaprim was proposed for the treatment of complicated skin and skin structure infections (cSSSI), the FDA indicated that additional clinical data are required to demonstrate efficacy, and refused to approve it. Iclaprim was under the aegis of Arpida, a Swiss company, then. Motif Bio acquired the rights to Iclaprim from Arpida in 2015.

Commenting on the news, Graham Lumsden, CEO of Motif Bio, said, "We are disappointed for patients and providers seeking an alternative antibiotic to treat ABSSSI. We intend to request a meeting with the FDA, which typically should occur within approximately 30-45 days, to discuss the Complete Response Letter. We look forward to working with the Agency to discuss options to advance iclaprim towards approval."

More than 3.6 million patients with acute bacterial skin and skin structure infections (ABSSSI) are hospitalized annually in the U.S. It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment.

Methicillin-resistant Staphylococcus aureus (MRSA) is the most common pathogen causing approximately 35% to 72% of skin and skin structure infections.

Some of the FDA-approved antibiotics for the treatment of ABSSSI include The Medicines Co.'s (MDCO) Orbactiv, Allergan plc's (AGN) Dalvance, Merck's (MRK) Sivextro, Melinta Therapeutics' Baxdela, Paratek Pharmaceuticals' Nuzyra.

MTFB closed Thursday's trading at $2.81, down 72.89%.