RICHMOND, Va.– Qnovia, Inc., a pharma company developing inhaled therapeutics with an initial focus on nicotine replacement therapy (NRT) and cardiopulmonary diseases, today announced its intention to pursue UK licensing by the Medicines and Healthcare products Regulatory Agency (MHRA) as a medicine to aid in smoking cessation.
“We are excited to engage with the MHRA and the wider opportunity to bring Qnovia’s prospective NRT therapeutic to the millions of patients in the UK who continue to struggle with nicotine addiction,” said Brian Quigley, CEO of Qnovia. “Gaining MHRA approval would validate the safety and efficacy of QN-01, just as we simultaneously seek approval in the U.S.”
In 2021, the MHRA established a regulatory framework to promote innovation in smoking cessation medicine. Qnovia has reviewed the guidance and completed a gap assessment of MHRA requirements. The company believes it is well-positioned to expand the reach and impact of its NRT therapeutic development efforts by pursuing regulatory approval and gaining a license as a smoking cessation medicine in the United Kingdom, in parallel with its U.S. regulatory approval plan.
“Our NRT indication is just the beginning for Qnovia,” said Mario Danek, founder of Qnovia. “We believe our technology has the potential to improve patient outcomes more widely, as we pursue expansion indications including asthma, COPD, depression, anxiety, and pain management.”
Qnovia recently raised $17 million in a Series A funding. The financing was led by Blue Ledge Capital and included DG Ventures, Evolution VC Partners, Gaingels, TL Capital, and Vice Ventures. The Series A proceeds will be used by Qnovia to advance the MHRA licensing strategy, progress the NRT drug candidate through a U.S. IND submission, and to begin human clinical trials in 2023.