Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company’s RespiRx vibrating mesh nebulizer platform. In September 2022, the company announced that it had raised $17 million for development of the nicotine replacement product.
The Phase 1 PK study enrolled 12 adult cigarette smokers and evaluated 3 different doses of QN-01 delivered by the RespiRx nebulizer. The study demonstrated that all 3 dosing regimens produced a higher Cmax and a lower Tmax than “an existing inhaled nicotine replacement therapy,” with dose-dependent pharmacokinetics, the company said.
Qnovia CEO Brian Quigley commented, “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.”
Quigley added, “We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most. We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”
Qnovia Chief Technology Officer Mario Danek said, “We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential. What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. 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.”
According to the Qnovia announcement, QN-01 “is currently being evaluated in the US under FDA’s Center for Drug Evaluation and Research (CDER) and in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA).”
Read the Qnovia press release.
