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Elusys Completes Phase III Studies Of Anthrax Anti-Toxin
Three phase III safety studies of obiltoxaximab (ETI-204, Elusys Therapeutics, Inc.) turned up no severe adverse effects in healthy adult volunteers, the company has announced. The conclusion of these studies marks the completion of Elusys' phase III clinical development program required for filing a biologics license application.
Obiltoxaximab is an antitoxin in development for the treatment of inhalational anthrax; data from these studies support the safety and tolerability of the antitoxin when administered intravenously (IV) at the intended dose. Elusys has also completed an additional dose escalation study to evaluate intramuscular (IM) administration of obiltoxaximab.
The first new safety study was a double-blind, randomized, placebo-controlled study that evaluated the safety and tolerability of a single IV dose (16mg/kg) of obiltoxaximab in healthy men and women at least 18 years of age who received obiltoxaximab (210 subjects) or placebo (70 subjects). Most adverse events (AEs) were mild to moderate in severity. The most frequently reported AEs related to obiltoxaximab were pruritus and headache.
The second trial was a double-blind, randomized, placebo-controlled study that evaluated the safety and tolerability of repeat IV administration of obiltoxaximab (16mg/kg) in 70 healthy volunteers at least 18 years of age. Half received obiltoxaximab on days 1 and 14 and placebo on day 120; the others received obiltoxaximab on days 1 and 120 and placebo on day 14. Most adverse events related to obiltoxaximab were mild to moderate; the most frequently reported were infusion-site swelling, infusion-site erythema, and infusion-site pain. No serious adverse events related to obiltoxaximab were reported.
An open-label, randomized, parallel-group drug–drug interaction study among 40 adults assessed the safety and tolerability of obiltoxaximab when given with ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Half the subjects received obiltoxaximab and ciprofloxacin, while half received obiltoxaximab alone. Ciprofloxacin had no effect on the pharmacokinetics of obiltoxaximab.
"The results from these three trials are consistent with findings from previous clinical studies of IV obiltoxaximab and together present a robust safety and tolerability profile for inclusion in our upcoming BLA filing," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys.
The clinical study was a randomized, double-blind, single ascending dose study to assess the safety, tolerability, and pharmacokinetics of single IM doses of obiltoxaximab in adult volunteers. The study enrolled 36 subjects across four doses of drug (4, 8, 16, and 24 mg/kg). Clinical conduct has been completed and final analysis is underway.
Obiltoxaximab is the only anthrax antitoxin in advanced stages of development that is being investigated for IV treatment and IM prophylaxis administration. It was granted fast track status and orphan drug designation by the FDA.
Source: Elusys Therapeutics, Inc.; September 22, 2014.