Qnovia said that its investigational inhaled smoking cessation therapy, QN-01, has shown a superior pharmacokinetic profile against current nicotine replacement therapies in a Phase 1 trial.

QN-01 is the firm’s lead asset, which has been designed to provide a safe and effective pharmacotherapy solution for individuals who want to quit smoking.

Formerly called Respira Technologies, Qnovia is using RespiRx, its proprietary inhaled drug delivery platform, to deliver the therapy candidate.

QN-01 is currently being assessed by health regulators in the US and the UK.

Qnovia CEO Brian Quigley said: “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.

“One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds.

“The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms.

“Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.”

The Phase 1 open-label trial studied the delivery of QN-01 for three different nicotine dosing regimens.

The goal of QN-01’s first-in-human study was to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who use combustible cigarettes.

Following a washout period, each adult got three separate doses of the investigational therapy administered on subsequent days.

The trial validated QN-01’s dose-dependent pharmacokinetics when administered via the RespiRx device.

In comparison to a current inhaled nicotine replacement treatment (NRT), QN-01 showed improved pharmacokinetics.

Qnovia’s therapy candidate demonstrated a high mean maximum plasma concentration (Cmax) and the duration to obtain the maximum plasma concentration (Tmax) was shorter across all three dosing regimens.

Additionally, the drug-device combination was well tolerated, with only a few typical minor side events of inhaled nicotine with no serious adverse events.

The Phase 1/2 clinical trial for the inhaled smoking cessation therapy candidate is expected to start in 2024.