According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says that it plans to initiate the Phase 1 study, which is expected to enroll 24 smokers, by the end of the year. The trial will compare nicotine delivered by the RespiRx vibrating mesh nebulizer to Pfizer’s Nicotrol nicotine inhaler and to conventional cigarettes.
Qnovia CEO Brian Quigley commented, “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 US 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. . . . 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.”
Chief Technology Officer Mario Danek said, “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.”
Read the Qnovia press release.
