Qnovia Launches Phase 1 Study for Innovative Nicotine Inhaler Targeting Smoking Cessation

Qnovia Launches Phase 1 Study for Innovative Nicotine Inhaler

Qnovia, Inc., a pioneering pharmaceutical entity specialized in inhaled therapies, has taken a significant step forward by commencing its Phase 1 clinical trial for the RespiRx™ Nicotine Inhaler in the United States. This trial marks a critical advancement in the quest for effective smoking cessation therapies, as smoking remains the foremost cause of preventable diseases and mortality in the country. Over 28 million smokers in the U.S. annually attempt to quit, but less than 10% succeed. Existing nicotine replacement therapies (NRTs), such as gums and patches, often lack the effectiveness needed due to their slow and low-level nicotine delivery.

The RespiRx™ Nicotine Inhaler is poised to revolutionize the smoking cessation landscape. As the first truly inhalable nicotine replacement therapy, it combines a portable, handheld nebulizer with metered dose cartridges that deliver nicotine as an inhaled mist — an innovation aimed at providing smokers with a more immediate and effective nicotine relief.

Brian Quigley, the CEO of Qnovia, expressed optimism regarding the trial, stating, "We are thrilled to have dosed our first patient in our Phase 1 study as we strive to address the global epidemic of combustible tobacco use and transform the treatment landscape for smoking cessation." He emphasized the urgent need for innovative treatment options in a market that has seen few advancements in decades. The initiation of this clinical trial signals Qnovia’s commitment to developing effective therapies for the millions of individuals seeking to quit smoking.

The Phase 1 study is structured to evaluate the pharmacokinetics, safety, and tolerability of the RespiRx™ Nicotine Inhaler among participants who are eager to quit smoking. Participants will self-administer the inhaler, along with the Nicotrol® Inhaler and combustible cigarettes, in a randomized, crossover, open-label setting involving up to 24 healthy adult smokers. Key endpoints of the study will include plasma nicotine Cmax, AUC0-30, and Tmax. Conducted by Dr. Vince Clinical Research in Overland Park, Kansas, this trial is critical for gathering clinical data to support future development.

Qnovia's innovative delivery technology has already shown promise in past studies. Earlier findings from a first-in-human study in the UK indicated favorable pharmacokinetics and pulmonary delivery, establishing a robust foundation for the ongoing Phase 1 trial in the U.S. Upcoming clinical data from the current trial is expected to be released in Q2 2025, with the company also planning to file a Clinical Trial Application in the UK later in the year.

Founded by Mario Danek in 2018, Qnovia aims to leverage its groundbreaking inhalation device technologies to enhance patient outcomes across various medical conditions. The RespiRx™ platform holds potential beyond smoking cessation, with applications in treating asthma, COPD, and other health issues. As the company endeavors to reshape the landscape of smoking cessation therapies, it stands as a beacon of hope for the millions of individuals striving to quit smoking and reclaim their health.

For more details on Qnovia and its pioneering efforts, visit www.qnovia.com.