Qnovia, Inc. announces FDA clearance of IND application for lead asset RespiRx™ Nicotine Inhaler as a prescription smoking cessation therapy

- Phase 1 clinical trial for smoking cessation expected to dose first patient in 4Q 2024 -

- The study will evaluate the pharmacokinetics, safety and tolerability of the RespiRx^™ Nicotine Inhaler compared to Nicotrol^® Inhaler and combustible cigarettes -

RICHMOND, Va., Oct. 1, 2024 /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 clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its lead asset, RespiRx^™ Nicotine Inhaler (QN-01).

The RespiRx is a drug device combination product that is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking. Smoking continues to be the leading cause of preventable death and disease in the U.S. Over half of the approximately 28 million smokers in the U.S. attempt to quit each year and less than one in ten is successful. Current NRT treatment options, 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 Company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety, and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.

"The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies," said Brian Quigley, Chief Executive Officer of Qnovia, Inc. "The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol^® Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the UK to support an MAA submission to the MHRA in 2026."

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 QN-01 in the UK. A press release summarizing the data can be found here.

"There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit 'cold turkey' remains the most popular method of quitting smoking," said Mitch Zeller, Qnovia's Policy and Regulatory Strategy Advisor. "There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit," Zeller added.

"Qnovia's platform for inhaled drug delivery is purpose fit to address this unmet need and we are proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking," said Mario Danek, Founder and Chief Technology Officer of Qnovia, Inc. "We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery," Danek added.

Upcoming Milestones

• First patient dosed in Phase 1 study for QN-01 in 4Q 2024
• CTA Submission for QN-01 in U.K. in 2025

About Smoking Cessation

Smoking continues to be the leading cause of preventable death and disease in the world, leading to almost 8 million direct and indirect deaths annually. Over half of the 28 million smokers in America and 6 million smokers in the UK attempt to quit every year. However, very few of these quit attempts are successful, and existing pharmacotherapies are severely under-utilized due to the lack of real-world efficacy. As a result, quitting "cold turkey" remains the most popular way to quit smoking, though this is also the least effective option. QN-01 is designed to meet the urgent need for a safe and effective pharmacotherapy with the potential to be a breakthrough in meeting the urgent need of millions of smokers who want to quit, but can't.

About Qnovia, Inc.

Qnovia, Inc., formerly Respira Technologies, Inc., is a pharmaceutical company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes across a growing range of indication areas. Qnovia sees significant opportunity to utilize its novel drug delivery technologies to improve the treatment of asthma, COPD, vaccine delivery, pain management, and infectious diseases using generic and 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 can be found at www.qnovia.com.

SOURCE Qnovia, Inc.