- Motif Bio plc's skin infection drug met the primary endpoint of a Phase 3 study, setting it up for a U.S. regulatory filing in early 2018.
- Iclaprim demonstrated non-inferiority in treating acute bacterial skin and skin structure infections (ABSSSI) compared to the current standard of care, vancomycin. Of the roughly 300 patients in the REVIVE-2 study who took Motif's drug, 78% saw their skin lesions get smaller within two to three days following administration. That percentage remained the same seven to 14 days after patients stopped receiving therapy.
- The REVIVE-2 results reaffirm those from another, almost identical investigation called REVIVE-1. Topline data from that late-stage trial came out earlier this year, and showed iclaprim was non-inferior to vancomycin at both the early clinical response and clinical cure points of the investigation.
One of — if not the — biggest threats to global health is antibiotic resistant bacteria. At least 700,000 people die from drug resistant diseases each year, according to a 2016 report from The Review on Antimicrobial Resistance, a research organization commission by the U.K. Prime Minister. The Review also anticipates that, by 2050, a person will die every three seconds from such illnesses.
Sensing the threat, pharmaceutical manufacturers have doubled down on developing antibiotics. Early last year, a coalition of more than 80 drugmakers, including big names like Pfizer Inc., Novartis AG and Johnson & Johnson, urged governments to work on making antibiotics a more central focus.
"We support the increasing recognition that the value assigned to antibiotics and diagnostics often does not reflect the benefits they bring to society, nor the investment required for their creation," the coalition said. "Therefore, we call on governments to commit to allocating the funds needed to create a sustainable and predictable market for these technologies while also implementing the measures needed to safeguard the effectiveness of antibiotics."
Biotechs have also actively pursued new treatments for infection. In July, Tetraphase Pharmaceuticals unveiled positive data from a late-stage study showing its antibiotic eravacycline was non-inferior to Merrem (meropenem) in treating patients with complicated intra-abdominal infections (cIAI). Melinta Therapeutics' Baxdela (delafloxacin) also locked down approval from the Food and Drug Administration this summer as a drug for adults with ABSSSI stemming from susceptible bacteria.
As for Motif's drug, the company touted the drug's similar safety and efficacy profile to vancomycin. Under a previous owner, iclaprim was rejected for not having enough data to show the drug actually worked and didn't pose an elevated risk of death.
“We believe that iclaprim, if approved, could be an important option for patients with ABSSSI, especially for those patients who may also have kidney disease, with or without diabetes," Motif CEO Graham Lumsden said in an Oct. 4 statement, adding that up to 26% of the ABSSSI population hospitalized annually has kidney disease.
"Unlike current standard of care antibiotics, in clinical trials to date, kidney toxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment. Iclaprim may be an important option for the growing population of patients with ABSSSI and kidney disease who need a safe and effective antibiotic targeting Gram-positive bacteria, including MRSA," he added.
U.K.-based Motif watched its shares rise more than 20% to £44.50 ($58.40) following the news. The company's stock also trades on the NASDAQ, though shares were down about 9% Wednesday.