RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.
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.
CEO Brian Quigley explained the technology to Drug Delivery Business News in 2022.
Qnovia already demonstrated dose-dependent pharmacokinetics and pulmonary delivery with its device in a first-in-human study. That study in the UK also saw patients tolerate the proprietary device well, helping to advance QN-01 in that geography.
“The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company, said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.
“We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the UK to support an MAA submission to the MHRA in 2026.”
