Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) and Novoteris, LLC recently signed a $2.8 million agreement to develop an inhaled nitric oxide antimicrobial treatment for patients who suffer from cystic fibrosis (CF). CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, will support Novoteris’ research to advance the treatment of airway bacterial colonization in CF patients.
Novoteris is conducting a pilot trial in Europe and has plans to initiate a phase 2b study during the third quarter of the year. The trial will be partially supported by an award granted by CFFT, as announced by the two new partners in a press release. The research is based on discoveries made by Dr. Chris Miller, who has conducted pioneering work on nitric oxide-based antimicrobial therapies.
Previous studies conducted by Novoteris demonstrated encouraging microbiological and lung function alterations in CF patients after two weeks of treatment with the inhaled nitric oxide antimicrobial therapy. The investigators believe that gaseous nitric oxide’s potent antimicrobialproperties, lack of bacterial resistance, and its small molecule penetration capabilities may offer a promising therapeutic alternative to non-antibiotic approaches that are usually used to treat infections in CF patients.
“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 II efficacy trial,” said the president of Novoteris, Alex Stenzler. “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.”
In addition to the CCFT grant, Novoteris announced that it will conduct a phase 2b study with the support of 12th Man Technologies, Inc., which will provide device development expertise, and Nitric Solutions Inc., which will offer scientific and clinical guidance for the trial. CF is a rare, hereditary condition that threatens the life of patients due to the excessive production of thick mucus in the lungs.
Lung infections and loss of lung functions are common outcomes of the disease, but the most common treatment for lung infections in CF patients, antibiotic therapy, often becomes ineffective due to bacterial resistance. The penetration of antibiotics is also inhibited by the thick mucus in the lungs. Novoteris believes that this new therapy is a potential alternative for CF patients.