US-based Novoteris has received a $2.8 million award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) for development of Thiolanox inhaled nitric oxide therapy for the treatment of bacterial lung infections in cystic fibrosis patients. The company said that it plans to use the funding for a Phase 2b study which is expected start by the third quarter of 2015.
Novoteris received US and European orphan drug designations for the product in 2013, shortly after the company launched. A two-week pilot study of the product in CF patients that was conducted in Europe “reported encouraging microbiological and lung function changes,” the company said.
According to Novoteris’s website, the company was formed specifically to continue development of the inhaled nitric oxide, which was initiated by 12th Man Technologies, Inc. and Nitric Solutions, Inc. 12th Man Technologies was formed when CareFusion spun off its Advanced Technologies Respiratory Team; Nitric Solutions was formerly known as Pulmonox Research & Development Inc. Both companies will continue to participate in the development of Thiolanox.
Novoteris President Alex Stenzler commented, “Based on the success of our pilot trial, and the broad spectrum of bacteria and fungi that our product has demonstrated effectiveness against, we anticipate a high level of patient eligibility and interest for our Phase 2 efficacy trial. We are expecting that our program will provide a novel and the first inhalable gaseous antimicrobial agent for the treatment of patients with this devastating disease.”
Read the Novoteris press release.
