Qnovia, Inc. Announces First Patient Dosed in U.S. in Phase 1 study for RespiRx™ Nicotine Inhaler as a prescription smoking cessation therapy

- RespiRx™ Nicotine Inhaler is the world's first truly inhalable nicotine replacement therapy -

- Clinical data from Phase 1 study for RespiRx™ Nicotine Inhaler in U.S. expected in Q2 2025 –

RICHMOND, Va., Jan. 7, 2025 /PRNewswire/ -- Qnovia, Inc., a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx^™, today announced the first patient was dosed in its Phase 1 clinical trial evaluating RespiRx™ Nicotine Inhaler (QN-01) as a smoking cessation therapy in the U.S.

Smoking continues to be the leading cause of preventable disease and mortality in the U.S. Over half of the approximately 28 million smokers in the country attempt to quit each year and less than one in ten is successful. Current nicotine replacement therapies (NRT), including nicotine gums and patches, are less effective as they all deliver nicotine slowly and at low levels due to buccal or transdermal delivery when compared to delivery via inhalation.

The RespiRx^™ is a drug device combination product that is the first truly inhalable NRT to assist smokers attempting to quit smoking. It is a portable, hand-held nebulizer that delivers medicine as an inhaled mist through metered dose cartridges.

"We are delighted 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," said Brian Quigley, Chief Executive Officer of Qnovia, Inc. "Smoking remains one of the most challenging addictions to overcome and it has been several decades since we have seen novel treatment options available to patients. The commencement of our Phase 1 study in the U.S. underscores our commitment to bringing an innovative therapy to the market to redefine what is possible for the millions of smokers who are looking to quit. We are proud to have reached this meaningful milestone and are excited to transition our RespiRx™ Nicotine Inhaler into the real-world setting. Overall, we believe that today's news represents Qnovia's official transformation into a biopharmaceutical company developing the next generation of smoking cessation therapies."

The Phase 1 study aims to address the critical need for effective and accessible smoking cessation therapies and is designed to assess the pharmacokinetics, safety and tolerability of RespiRx™ Nicotine Inhaler in individuals looking to quit smoking. The study is a randomized, crossover, open-label trial evaluating the self-administration of RespiRx™ Nicotine Inhaler, Nicotrol^® Inhaler, or combustible cigarettes in up to 24 healthy adult subjects who currently smoke combustible cigarettes. The primary endpoints includes baseline-adjusted plasma nicotine Cmax, AUC_0-30, and Tmax.  The study is being conducted by Dr. Vince Clinical Research, a clinical research organization based in Overland Park, KS.

Qnovia's proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing RespiRx™ Nicotine Inhaler in the UK. A press release summarizing the data can be found here.

Upcoming Milestones

Clinical data from Phase 1 study for RespiRx™ Nicotine Inhaler expected in Q2 2025

Clinical Trial Application Submission for RespiRx™ Nicotine Inhaler in U.K. in 2H 2025

About Qnovia, Inc.

Qnovia, Inc. is a pharma company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes. The company's drug delivery platform, the RespiRx™, is the first orientation-agnostic, portable vibrating mesh nebulizer that effectively operates in any position held by the patient. Qnovia sees significant opportunity to utilize its drug delivery technologies to improve the treatment of Asthma, COPD, Vaccine Delivery, Pain Management, and several generic as well as select investigational new drugs. The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies. The company's website can be found at www.qnovia.com.

SOURCE Qnovia, Inc.