Qnovia CEO to Speak at Public Meeting with FDA and NIH

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Qnovia Inc. CEO Brian Quigly will speak publicly at a joint meeting with the FDA and NIH as part of the Advancing Smoking Cessation campaign.¹

In a press release, Quigley said, “I am encouraged by the opportunities recently outlined by FDA and NIH for pursuing innovation in smoking cessation, an area with no new therapies approved in several decades. A modernization of the approach to smoking cessation medicines is overdue, and I am hopeful today's discussion will lead to more innovation in the industry.”

He continued, “The currently available nicotine replacement therapies (NRTs) deliver nicotine buccally or transdermally, resulting in suboptimal nicotine concentrations and ultimately a failure to provide relief from cravings or withdrawals in the real world. We believe an NRT that safely delivers pharmaceutical grade nicotine using the pulmonary route of administration can address the shortcomings of existing therapies. We are committed to directly addressing this unmet public health need through the development of our lead asset QN-01, a prescription inhaled smoking cessation therapy. We will be advancing QN-01 through Phase 1 clinical trials this year and are committed to continuing to engage with regulators as we advance through the regulatory process in both the U.S. and U.K."

Qnovia recently announced FDA clearance of its IND application for the RespiRX Nicotine Inhaler as a prescription therapy for quitting smoking.² The company will begin Phase 1 studies on the device.

In a press release issued at the time, Quigley said, “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 de-risked 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. 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 policy and regulatory strategy advisor Mitch Zeller also said, “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. 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.”

Mario Danek, founder and chief technology officer at Qnovia 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. 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.”

Sources

1. Qnovia, Inc. CEO Speaks at FDA and NIH Public Meeting to Encourage Innovation of Smoking Cessation Treatment Options. Qnovia, Inc. October 21, 2024. https://www.prnewswire.com/news-releases/qnovia-inc-ceo-speaks-at-fda-and-nih-public-meeting-to-encourage-innovation-of-smoking-cessation-treatment-options-302280571.html
2. Qnovia, Inc. Announces FDA Clearance of IND Application for Lead Asset RespiRx™ Nicotine Inhaler as a Prescription Smoking Cessation Therapy. Qnovia, Inc. October 1, 2024. Accessed October 21, 2024. https://www.prnewswire.com/news-releases/qnovia-inc-announces-fda-clearance-of-ind-application-for-lead-asset-respirx-nicotine-inhaler-as-a-prescription-smoking-cessation-therapy-302263046.html