Qnovia has announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy.
QN-01 is currently being evaluated in the US by the FDA’s Center for Drug Evaluation and Research (CDER) and in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Smoking continues to be the leading cause of preventable death and disease, leading to almost eight million direct and indirect deaths annually.
QN-01 is designed to meet the urgent need for new safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs).
“This data demonstrates our device has significant potential in bringing new hope to smokers who want to quit smoking,” said Mario Danek, Founder and Chief Technology Officer of Qnovia. “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.”
Existing pharmacotherapies lack the rapid onset and peak levels of nicotine delivery to effectively alleviate cravings and withdrawal symptoms during a quit attempt.
The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs. QN-01 achieved targets for both peak nicotine concentration and time to achieve peak nicotine concentration.
“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,” explained Brian Quigley, CEO of Qnovia. “We believe our nicotine delivery platform could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most.”