Led by a former tobacco company executive, Qnovia looks to offer nicotine replacement therapy through inhaled drug delivery.
Brian Quigley spent just over 16 years at tobacco giant Altria. During his time there, he ran two U.S. business units, including the smokeless tobacco business.
In July 2020, he joined founder and then-CEO at Qnovia (then Respira Technologies) Mario Danek as chief operating officer. Now CEO, with Danek as chief technology officer, Quigley leads the company as it looks to bring a prescription smoking cessation therapy to market.
Quigley acknowledged the potential applications Qnovia could pursue with its inhaled therapeutic technology. For now, though, the focus is firmly on pursuing FDA approval for what would be the first inhalable prescription smoking cessation therapy.
“I joined Qnovia because of what I learned when I first met Mario Danek,” Quigley told Drug Delivery Business News. “He explained this innovation he created. He’s taken proven medical device technology and been able to imbue it with form factors for better compliance, better adoption and better patient outcomes.”
Qnovia’s RespiRx drug delivery platform leverages a vibrating mesh nebulizer. The aerosol technology has been used to deliver therapeutics for decades, Quigley said.
However, he noted that they “really suffer” from a range of challenges. For instance, the devices are gravity-fed. This means the piece that has to pour the drug product comes into contact with the mesh itself. He called them “clunky” as they require cleaning. According to Quigley, they can contribute to poor adherence due to the need to clean the devices.
Qnovia took the approach of miniaturizing the technology and making it work in an orientation-agnostic fashion. This helps it to deliver therapeutics in a patient-friendly way, he said.
The device features a rechargeable base unit, plus an interface for patients to track their dosing. They can follow their use regimen and capture data through the device. The device also has a pre-filled drug product-containing cartridge. Quigley said the patient can stick this into the end of the device to start therapy, then replace it when needed as they move through therapy.
“It has a very familiar patient-friendly format for on-the-go treatment to deliver the drug wherever you need it and to do it effectively,” Quigley said.
Different regimens for different users?
Based on each indication Qnovia treats with its technology, each user would have a different use regimen, Quigley said.
Each user received a prescribed target dose based on the therapy, the treatment and the outcome, specifically for inhalable nicotine replacement therapy. That particular treatment has a 12-week use regimen. Quigley described it as a traditional “step-down” model, where the patient first puts down the cigarettes. Then they begin using the device, which helps them reduce nicotine use over 12 weeks before they stop using it altogether.
In the case of smoking cessation therapy, Qnovia has a precisely timed and delivered dose prescribed to the patient based on the number of cigarettes they used to smoke in a day. Each therapy has a specific number of activations to deliver the drug to the body to alleviate withdrawal symptoms.
“That kind of algorithm of the dosing, the dose control and the delivery is a function of the indication,” explained Quigley. “That would be very different for any future indication. If we were working asthma or COPD, for example, the device itself can be programmed to deliver that drug differently based on the patient needs.
Each of those drugs represents billion-dollar opportunities, he says. However, patients currently have to use large, clunky or at-home nebulizers to dispense the drug, which is where Qnovia could come into play.
Additionally, Quigley pointed to the world of drug development as an opportunity. He said inhalation represents an effective way to deliver compounds to the body, particularly for respiratory disease.
Finally, he pointed to companies looking at drugs delivered in different ways. Those can be delivered with less patient friction but the same efficacy and route of inhalation.
“There’s still a lot of work to be done,” said Quigley. “That’s why we’re focusing first on the smoking cessation therapy indication. As we continue the development, we can identify and build up a pipeline of the other potential drugs we could be delivering or drugs and development that we can partner with other companies to deliver.”
Qnovia took one large step forward last month by raising a $17 million Series A funding round. Its plans include investigational new drug submission to the FDA next year, followed by Phase 1 clinical trials.
According to Quigley, the company has the capital to get through Phase 1 trials and to explore application programming interfaces (APIs) and expansion opportunities.
‘”Getting through that Phase 1 human clinical trial is our next major milestone, and we’re funded to do that for sure,” said Quigley. “From there, our fate we would begin with Phase 2 studies in the back half of next year. And then move through Phase 3 in the new drug application.”
As for the future indications, Quigley said it’s hard to predict when public communications will come for those. The company’s focus remains on advancing its smoking cessation treatment.
“We’re really excited to have the support of the investors we have,” said Quigley. “We think that this technology to deliver health therapeutics has big potential. Advancing our smoking cessation application, first and foremost, is just a massive opportunity to improve the lives of millions of people.
“We’re excited to advance that and to continue to identify and bring to market additional indications that can help improve outcomes.”