Novoteris to Start Phase 2 Trial of Its Nitric Oxide Product Thiolanox as Cystic Fibrosis Treatment
Novoteris will begin recruiting cystic fibrosis (CF) patients for a Phase 2 clinical trial of its inhaled nitric oxide product Thiolanox for treating the life-threatening disease.
The announcement came after the U.S. Food and Drug Administration and Health Canada’s Therapeutic Products Directorate approved the company’s clinical trial application.
Lung infections are the leading cause of CF progression and death. Antibiotics become ineffective against infections as bacteria develop resistance to them.
In addition, thick mucus in CF patients’ lungs makes it difficult for antibiotics to penetrate bacterial colonies. So there is an urgent need to develop alternatives to current bacterial treatments.
Nitric oxide is a naturally occurring gas that can reduce lung infections, leading to improved respiratory function in people with CF.
The gas can counter gram-positive and gram-negative bacteria, viruses, fungi and yeast. Gram-positive bacteria are more susceptible to antibiotics than gram-negative bacteria. And gram-negative negative bacteria are more likely to develop resistance to the drugs.
A Phase 1 trial revealed that inhaled nitric oxide is safe and well tolerated in healthy people.
“The clearances by the FDA and Health Canada will enable us to advance our work with this novel therapy and represents an important step for Novoteris,” Alex Stenzler, the company’s president, said in a press release.
The multi-center, randomized, placebo-controlled Phase 2 study (NCT02498535) will recruit 60 patients from CF research centers in Seattle, Los Angeles, Milwaukee, Charleston and Vancouver.
Patients will be treated with either Thiolanox nitric oxide or a placebo. Novoteris will deliver both with its computerized trace-gas mixing system.
The primary goal of the trial is to compare the treated and placebo groups’ change in lung function between the start of the therapy and the 15th day. Researchers will use a lung function measure called FEV1.
The therapy’s broad-spectrum anti-microbial properties means the trial will be open to most CF patients. The only patients excluded will be those with Non-Tuberculosis Mycobacterium. Novorteris said this group will be analyzed in coming studies.
“This new application brings years of work with nitric oxide gas for antimicrobial uses to the clinical forefront,” said Chris Miller, Novoteris’ chief technology advisor.
The Cystic Fibrosis Foundation Therapeutics has supported development of inhaled nitric oxide antimicrobial therapy for CF.
For more information about the Phase 2 trial, including how to participate, please visit this link.