Qnovia to Pursue UK Approval for Lead Asset QN-01 in Nicotine Replacement Therapy
08 Nov 2022
Vaccine
RICHMOND, Va.--(BUSINESS WIRE)--Qnovia, Inc. (“Qnovia”), 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.
'Gaining MHRA approval would validate the safety and efficacy of QN-01, just as we simultaneously seek approval in the U.S.'
“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.
About Qnovia, Inc.
Qnovia, Inc., formerly Respira Technologies, Inc. is a pharma company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes. The company’s drug delivery platform is the first orientation-agnostic, portable vibrating mesh nebulizer that effectively operates in any position held by the patient. Qnovia sees significant opportunity to utilize its drug delivery technologies to improve the treatment of asthma, COPD, vaccine delivery, pain management, and several generic as well as select investigational new drugs. The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies. The company can be found at www.qnovia.com.
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