Motif pummelled as FDA asks for more data on antibiotic

Shares in UK biotech Motif Bio fell more than 50% after its much-delayed antibiotic was held up at the FDA once again by a request for another clinical trial.

The US regulator has confirmed it wants to see another trial of iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI) before it will consider approval. In particular, it wants the study to settle lingering concerns about the potential of iclaprim to cause liver toxicity.

AIM-listed Motif attempted to put a positive spin on the news, billing it as clarity on the potential path forward for the programme after it received a complete response letter (CRL) from the FDA in February, driving the stock down to penny share territory.

The news clearly came as a big disappointment to the company’s investors, who had been hoping that a whole new study would not be required and that there might still be a chance of a near-term approval and launch.

Motif still isn’t speculating on the likely length of the delay but it’s worth noting it is getting low on cash, at $2.3 million as of the end of May, with $7.1 million of outstanding debt, that only gives it an operating runway out to September. That means it will need to raise additional financing – or find a partner – if it is to carry out the FDA’s request.

“We intend to meet with the agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements,” commented Motif’s chief executive Graham Lumsden.

“In parallel, we expect to continue our discussions with potential commercial partners and will determine the best options for funding the trial once we have clarity from the FDA.”

Motif Bio has already run two trials trying to show that iclaprim is at least as effective as the mainstay antibiotic vancomycin in treating ABSSSIs, and could provide another option for patients in the face of increasing levels of vancomycin-resistant infections.

The UK firm picked up the rights to the antibiotic in 2014, five years after it was rejected by the FDA for the first time on the grounds that it seemed to pose a risk of QT prolongation, a cardiac side effect. It was originally developed by Roche and spun out into a company called Arpida in 2001.

“We continue to believe that iclaprim has the potential to be an important new treatment option for hospitalised patients with ABSSSI and potentially also in patients with hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia,” said Lumsden.