Shots:
- Brian talked about the $17 million in Series A funding led by Blue Ledge Capital including other ventures
- Brian also spoke about multiple products being developed in Qnovia’s pipeline. The funding will advance its NRT drug candidate through an IND submission in 2023
- The interview gives an understanding of how Qnovia is developing innovative products for cardiopulmonary diseases
Smriti: Congratulations on the Series A. Can you please talk about the Series A funding received by Qnovia?
Brian Quigley: We raised $17 million in Series A, which was led by Blue Ledge Capital and had participation from DG Ventures, Evolution VC Partners, Gaingels, TL Capital, and Vice Ventures.
Smriti: How is Qnovia planning to use the funds raised?
Brian Quigley: The proceeds from Series A are being allocated to advance the regulatory applications for the NRT indication area in the U.S. and UK, including our Phase 1 human clinical trials. The funds also support the testing and development of inhaled drug delivery partnership discussions, and the evaluation of other active pharmaceutical ingredient (API) candidates for our internal pharma portfolio.
Smriti: Can we talk about the products being developed & indications being assessed by Qnovia?
Brian Quigley: We have product development focused across four indication areas at various stages of development. In addition, there are multiple indications we are discussing with potential partners that would only be pursued under co-development.
Our internal development products include QN-01 focused on the NRT Indication. As described above, we are pursuing a prescription designation in the U.S. and a medicines license in the UK for QN-01. QN-01 is completing pre-clinical and we plan to submit our IND and begin human clinical next year.
QN-02 is a product to treat Asthma and COPD. Currently, we have identified and are assessing four target API candidates for this product. QN-03 is focused on migraine relief and pain management. In this indication area, we’ve identified five priority APIs for further development and QN-04 is focused on depression where there are two APIs of focus.
Across QN-02-QN-04, we plan to advance through the assessment phase including final DP formulation, stability, aerosol characterization, and non-clinical studies where needed. All of the products we are developing will be advanced through either the aNDA or 505(b)(2) pathway.
Smriti: Let us discuss the development timeline and pathway of lead molecule NRT from Qnovia.
Brian Quigley: For the QN-01 NRT indication, our next milestone is to submit our IND and begin Human Clinical trials next year. The ultimate path to approval will be dictated by our clinical studies and guidance from FDA. We are currently wrapping up inhalation toxicity safety studies in two animal models and are in the validation and verification stage.
In the UK, we have the benefit of a more streamlined clinical pathway versus the U.S. pathway, which should lead to more rapid approval.
Smriti: Please elaborate more on Respira.
Brian Quigley: The Qnovia platform at its core leverages proven vibrating mesh mechanical function for the deep lung delivery of drugs safely and is designed to address the shortcomings of existing platforms. Specifically, the device has superior human factors, is orientation agnostic, portable, and requires no maintenance or cleaning.
The drug-product-containing cartridge is aseptically filled, achieves FDA requirements for container closure integrity, and has a fully sealed airpath to dispense a precise dose via breath activation. The device body also contains an LCD screen that can display support prompts, real-time dosage, and battery life as well as other information to increase compliance and adherence rates. Additionally, the device is also Bluetooth enabled for potential companion app integration.
Smriti: Can we discuss Qnovia’s molecule being developed for cardiopulmonary patients?
Brian Quigley: For confidentiality and competitiveness reasons, at this time, we are not publicly disclosing specific APIs that we are working on.
Thank you.
Source: Canva
About the Author:
Brian Quigley is the CEO of Qnovia. He has 25 years of marketing, regulatory, operations, and general management experience for public companies, private equity-backed businesses, and venture-backed businesses. He developed a focus on inhalation devices through his time in tobacco, which gave him an understanding of the risks of tobacco use, the opportunity to reduce risks for smokers, and the current generation of technologies.
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