Shots:

• Brian spoke about why Respira Technologies has been rebranded as Qnovia
• Brian also talked about how Qnovia is working to advance its first inhalable prescription smoking cessation therapy and its applications
• The interview summarizes how this rebranding will accelerate Qnovia’s technology and products from others in the biotechnology space

 Smriti: Would you please start off by mentioning the reason behind rebranding Respira as Qnovia.

 Brian Quigley: There are many entities with corporate brands/identities in the Pharma and adjacent spaces that use Respira or "Respi'' and it was leading to confusion.  In an effort to differentiate our corporate brand from other entities, we wanted to create a unique identity we could own.  That is why we chose to rebrand to Qnovia, Inc.

Smriti: As Qnovia oscillates around the production of inhalation device technologies, what are the products being developed by the company for smoking cessation therapy?

Brian Quigley: The company is advancing a combination device application pursuing approval as an inhaled smoking cessation therapy. This original application combines our proprietary inhaled delivery device technology and our drug product designed to alleviate withdrawal symptoms.  For smoking cessation, we expect additional applications to follow the initial application, including the development and approval of a companion app interface designed to help the patient monitor their therapy, increase adherence rates, and improve patient efficacy outcomes.

Smriti: How does Qnovia plan to proceed with its inhalation product into clinical trials for smoking cessation therapy?

Brian Quigley: Our next step is to submit our IND to FDA and upon approval, we will begin our Phase I human clinical studies next year. Ultimately, we will execute Phase I, II, and III studies with input from FDA to complete our New Drug Application. The clinical path for an NRT application has clear guidance on goals and endpoints from FDA and we are confident our plans will support approval as there is an urgent need to provide smokers with new, safe, and effective therapies to successfully quit smoking.

Smriti: Highlight the reasons why Nicotine Replacement Therapies (NTRs) require a major update and how?

Brian Quigley: There hasn't been a new therapy to help smokers quit in almost 15 years.  Today, in 2022 almost 60% of the 40MM smokers in the US plan to try to quit this year.  With the current therapies, most of those attempts will fail.  Smokers have tried the current NRT products, and they know those products don't alleviate withdrawal symptoms due to the slow delivery of nicotine buccally and transdermally. Our therapy is designed to deliver nicotine at lower levels than a cigarette but to deliver the drug via inhalation rapidly which has the potential to alleviate cravings and withdrawals more effectively.  This is the critical point on the smoker’s journey and when they fail.  The inhaled delivery of the drug will help manage cravings and help the patient reduce their nicotine dependence over the 12 weeks of use.  Importantly, the inhalation technology we use to deliver the drug to the lung can achieve the FDA's standard of safety as it utilizes no heat to create a laminar, inhalable aerosol delivered to the patient.

Smriti: As you have mentioned engaging with the world’s leading healthcare companies, please tell us more about the companies you are expecting to collaborate with in the future along with the expected geographical locations.

Brian Quigley: As a venture-backed start-up, we have to stay laser-focused on the primary indication of smoker cessation, however, we see significant opportunities to improve patient adherence and compliance vs. other inhaled drug delivery technologies.  We also see significant opportunities to improve patient outcomes in the areas of Asthma, COPD, Pain Management, Migraine Relief, and more. Currently, companies who have reached out to us are also exploring opportunities to improve patient outcomes with inhaled drug delivery across these and other indication areas but are looking for a breakthrough device technology for their drug(s). Although we are currently focused on the US market, we remain open to pursuing partnerships globally.

Smriti: Please give readers a brief insight into your product pipeline. Also, highlight Qnovia’s plans for the advancement of this product pipeline.

Brian Quigley: Our pipeline is first focused on the multiple applications we plan to pursue on the NRT product.  First, we plan to achieve FDA authorization as a prescription, we will then submit an application to include the mobile phone-enabled patient interface. Outside of NRT, we are focused on indications where the benefits of inhaled delivery (higher bioavailability and speed of absorption) along with the need to address patient compliance and adherence have the opportunity to improve patient outcomes. This is a vast space ready for disruption. Currently, we've identified target drugs in Asthma, COPD, Pain Management, Migraine relief, and Depression that we are in the early stages of exploring for additional applications to the FDA.  

Source: Canva

About the Author:

Brian Quigley is the CEO of Qnovia. He has 25 years of marketing, regulatory, operations, and general management experience for public companies, private equity-backed businesses, and venture-backed businesses. He developed a focus on inhalation devices through his time in tobacco, which gave him an understanding of the risks of tobacco use, the opportunity to reduce risks for smokers, and the current generation of technologies. 

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