Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company’s RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the FDA had cleared an IND for the trial, which is expected to enroll 24 healthy adults who are current cigarette smokers. Results from a previous Phase 1 trial of were announced in November 2023.
According to the announcement, Qnovia also expects to submit a UK clinical trial application in the second quarter of this year. The company recently said that it had raised $16 million for development of QN-01 in the UK as well as in the US, with plans to submit an MAA to the MHRA in 2026.
Qnovia CEO Brian Quigley commented, “We are delighted to have dosed our first patient in our Phase 1 study as we strive to address the global epidemic of combustible tobacco use and transform the treatment landscape for smoking cessation. . . . We are proud to have reached this meaningful milestone and are excited to transition our RespiRx nicotine inhaler into the real-world setting. Overall, we believe that today’s news represents Qnovia’s official transformation into a biopharmaceutical company developing the next generation of smoking cessation therapies.”
Read the Qnovia press release
