Qnovia, Inc. announces positive results from first-in-human pharmacokinetic and safety study of lead asset QN-01, a prescription inhaled smoking cessation therapy

Qnovia, Inc. announces positive results from first-in-human pharmacokinetic and safety study of lead asset QN-01, a prescription inhaled smoking cessation therapy

• QN-01 achieved target Cmax and Tmax concentrations in a Phase 1 study demonstrating a superior pharmacokinetic profile compared to existing nicotine replacement therapies -
• Qnovia’s proprietary drug/device combination demonstrated dose-dependent pharmacokinetics and was well tolerated in patients -
• IND and CTA submissions for QN-01 are expected to be filed in 2024 -

Richmond, VA, November 29, 2023 – Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx^TM, today announced positive results from its first in-human study of QN-01, the company’s lead asset. QN-01 is an inhaled smoking cessation therapy that is currently being evaluated in the U.S. under FDA’s Center for Drug Evaluation and Research (CDER) and in the U.K. by the Medicines and Healthcare Products Regulatory Agency (MHRA).

"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,” said Brian Quigley, CEO of Qnovia, Inc. “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.”

“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,” continued Quigley. “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.”

The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.

The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the RespiRx^TM device. The mean maximum plasma concentration (C_max) was higher, and the time to achieve the maximum plasma concentration (T_max) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

Highlights of Initial Phase 1 Pharmacokinetic and Safety Data

^{1 Reference Cigarette and NRT PK data from publications:}

^{https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9160848/pdf/12954_2022_Article_638.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9424205/}

“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 C_max 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,” said Mario Danek, Founder and Chief Technology Officer of Qnovia. “What makes our platform unique is that the RespiRx^TM device utilizes a vibrating mesh nebuliser 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."

Upcoming Milestones

QN-01 IND Submission in U.S. in 2024

QN-01 CTA Submission in U.K. in 2024

QN-01 Phase 1/2 clinical trial to begin in 2024

About QN-01 for 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 pharma company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes across a growing range of indication areas. The company’s drug delivery platform 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 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.