As (Nasdaq:QNRX) gains strength, COO Denise Carter talks about what’s next for Quoin Pharmaceuticals
Netherton Syndrome (NS) is a rare and devastating skin disease that is estimated to affect between 2,000 and 4,000 people in the United States, and a similar number in Europe. It has no cure, and current treatment primarily involves the use of over-the-counter moisturizers which provide only minor symptomatic relief.
Quoin Pharmaceuticals’ investigational product for NS, QRX003, may become the first approved treatment available to patients. It acts on skin to reduce the excessive shedding characteristic of NS and which results in patients’ skin being highly porous and therefore not functioning as the effective barrier it was designed to be. QRX003 is a topical lotion which, if approved, will be used on the entire body surface every day to enable the skin architecture to recover while providing an effective barrier over the skin to limit penetration by unwanted environmental agents.
The company’s share price has seen an increase of 52% in the past month, and as Quoin sees continued positive momentum this week, Chief Operating Officer and company co-founder, Ms. Denise Carter, joins us to answer some questions about what’s next for the company as it marches toward commercialization of QRX003
Q: Quoin has received constructive feedback from the FDA for the development of QRX003. Can you tell us more about what the clinical requirements are?
A: Last week, we submitted our Investigational New Drug (IND) filing with the FDA, an important milestone as we work to bring QRX003 to an underserved patient population. Previously, the FDA provided Quoin with constructive guidance based on our pre-IND submission, indicating that a total patient population of approximately 20 subjects, at the commercial dose, may be sufficient for approval.
Q: You are targeting seeking regulatory approvals for QRX003 in both the US and EU in 2024. What are the next steps on the regulatory pathway?
A: We’ve already received guidance from the US FDA and so the next step was to seek guidance from the regulators in Europe. Earlier this month we submitted a Scientific Advice Briefing Document to the European Medicines Agency (EMA), which is the first step in the formal development process of QRX003 as a potential treatment for Netherton Syndrome in the EU. Based on this submission, the EMA will provide guidance on the clinical and regulatory requirements to advance the development of the product.
Q: When will clinical trials for QRX003 begin?
A: In the US, we are preparing to start our clinical trial in the first half of 2022. Netherton Syndrome is a very rare condition, so we have been working closely with supporting foundations and leading dermatology experts who treat these patients, to ensure that trial enrollment is a smooth and efficient process.
Q: How will you go about commercializing QRX003 once you have obtained regulatory approvals?
A: Our goal is to launch immediately upon receiving approvals in our two key markets, to get our products to patients as quickly as possible. We will be using our own commercial infrastructure and we anticipate that fewer than 30 people will be sufficient to support both US and European markets. In addition, we have secured exclusive distribution and revenue-sharing agreements covering nearly 60 countries, which brings us closer to our goal of getting our product to every patient, everywhere who needs it.
Q: Quoin has demonstrated its strategic approach to developing and commercializing its products. What would you say to new investors asking about the company’s value drivers?
A: Quoin is potentially positioned to deliver the first FDA-approved treatment for Netherton Syndrome. We believe our product works and our clinical trials will provide the data we need to take it to patients around the world. As a rare disease, Netherton Syndrome has a smaller addressable market, but that market is defined and concentrated, and with no approved treatment or cure, so there is little competition in the space. Rare and orphan drugs also have higher pricing power and can be highly profitable. QRX003 is a once-daily topical treatment that patients will use for life, making it a long-term marketing opportunity for Quoin. Finally, we have a strong balance sheet and a robust pipeline of different products that will potentially address a range of rare skin diseases for which there are no approved treatments or cures.