Qnovia, Inc. has secured FDA clearance for its Investigational New Drug (IND) application for RespiRx Nicotine Inhaler (QN-01), an innovative approach to nicotine replacement therapy (NRT). This clearance paves the way for a Phase 1 clinical trial to evaluate the NRT's pharmacokinetics, safety, and tolerability in individuals seeking to quit smoking.
RespiRx: A Novel Inhalable NRT
RespiRx (QN-01) is designed as the first inhalable prescription NRT, offering a user-friendly, cartridge-based medical-grade inhaled drug delivery system. Each aseptically filled cartridge contains the drug product and a proprietary aerosol-generating technology. The device is breath-activated, delivering precise nicotine doses via inhalation, addressing cue-induced relapse behavior. It also tracks and displays real-time dosing to aid patients in adhering to a 12-week step-down regimen.
Clinical Trial Design and Objectives
The upcoming randomized, crossover, open-label Phase 1 trial will evaluate RespiRx in healthy adults who smoke cigarettes. The study aims to determine the pharmacokinetics, safety, and tolerability of the inhaler, comparing it to both combustible cigarettes and Pfizer's (now discontinued) Nicotrol inhaler. This head-to-head comparison will provide valuable insights into the efficacy and patient experience with RespiRx.
Prior Clinical Data
The FDA's clearance follows positive outcomes from an earlier first-in-human study, which assessed QN-01 delivery across three different nicotine dosing regimens. This open-label Phase 1 trial examined the pharmacokinetics and safety profile of the drug delivery platform in 12 healthy adult smokers.
Key findings from this study included dose-dependent pharmacokinetics of QN-01 delivered via the RespiRx device. The mean maximum plasma concentration (Cmax) was notably higher (12.9 ng/ml), and the time to achieve maximum plasma concentration (Tmax) was lower for QN-01 across all three dosing regimens (low: 7.9; mid: 9.4; high: 14.6). These results demonstrated more favorable pharmacokinetics compared to existing inhaled NRT (Cmax: 2.3 ng/ml; Tmax: 15). The drug-device combination was well-tolerated, with no serious adverse events (AEs) reported; only minor AEs typical of inhaled nicotine were observed.
The Need for Innovative Smoking Cessation Therapies
Despite available treatments, quitting "cold turkey" remains a common method, highlighting the need for more effective tools. Current NRT options, such as nicotine gums and patches, deliver nicotine slower and at lower levels compared to inhalation, potentially limiting their effectiveness.
Future Plans
Qnovia anticipates dosing its first patient in the fourth quarter of 2024. Concurrently, the company is advancing towards a pivotal clinical trial in the UK to support a marketing authorization application submission to the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2026.
