Qnovia announced positive results from its first-in-human study for the QN-01 inhaled smoking cessation therapy.
Richmond, Virginia-based Qnovia develops the RespiRx drug delivery platform that leverages a vibrating mesh nebulizer. CEO Brian Quigley explained the technology to Drug Delivery Business News last year.
The company designed the QN-01 therapy to meet the need for safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs). According to Qnovia, existing pharmacotherapies lack the rapid onset and peak levels of nicotine delivery. They fail to effectively alleviate cravings and withdrawal symptoms during a quit attempt.
Results from the first-in-human study demonstrated a superior pharmacokinetic profile compared to existing NRTs, Qnovia says. QN-01 achieved targets for both peak nicotine concentration and time to achieve peak nicotine concentration.
“This data demonstrates our device has significant potential in bringing new hope to smokers who want to quit smoking,” said Mario Danek, Qnovia founder and chief technology officer. “Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”
Qnovia plans to share its data with the FDA in an investigational new drug submission. The company hopes to make QN-01 the first inhalable nicotine replacement therapy capable of treating smokers who want to quit but can’t.
“Today marks a pivotal milestone for Qnovia, as we believe this data validates the clinical translation of our platform for the first time in patients,” Quigley said. “We believe our nicotine delivery platform could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most.”