Quoin Fortifies Position to Potentially Deliver First Treatment for Netherton Syndrome
In a significant step for the clinical-stage specialty pharmaceutical company and Netherton Syndrome patients, Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) has initiated dosing of the first patient in its open-label clinical trial. The ongoing trial is evaluating the safety and efficacy of Quoin’s lead candidate, QRX003, in Netherton Syndrome patients who are currently receiving off-label systemic therapy. Quoin anticipates sharing topline data in the second half of the year.
Last month, Quoin completed a public offering that brought in net proceeds of about $6 million. Its cash position is at its strongest level ever with a financial runway that extends into the second half of 2024. In addition to advancing the clinical development of its product pipeline, this strong financial position will support the company’s plans to pursue attractive M&A opportunities in the rare and orphan disease space with several opportunities already being actively explored. Quoin ended 2022 with approximately $12.9 million in cash and marketable securities.
The company’s single-arm study is running concurrently with its double-blinded vehicle-controlled study being conducted under the same open Investigational New Drug (IND). With five of six planned clinical sites fully opened and operationally ready to initiate patient recruitment and testing, the two studies engage the same investigators and clinical sites, enhancing operational synergies and cost savings.
This open-label study in approximately 10 subjects is not placebo-controlled and all patients will be tested with a 4% dose of QRX003, applied once daily to a predesignated site on the body over a 12-week period. Quoin believes the data from both studies may be sufficient for some of its eight commercial partners to seek formal regulatory approval or inclusion of the product in early access programs in a number of the 60 countries where the product has been out licensed. The company is also working with regulatory consultants to determine if QRX003 may qualify for Conditional Marketing Approval (CMA) in Europe, which allows commercialization of a medical product in advance of formal regulatory approval. CMA is granted by the EMA when there is no available treatment for a particular disease and where a clearly defined medical need exists.
Throughout the upcoming quarter, Quoin will continue to deepen engagement with its Netherton community of patients, family members, treating physicians and supporting foundations to further establish awareness of Quoin and its ongoing clinical programs.
Quoin Pharmaceuticals CEO, Dr. Michael Myers said, “With our two clinical studies in Netherton patients actively recruiting and dosing patients, we are very encouraged by the level of interest and enthusiasm both of them are generating in the community as a whole. If approved, QRX003 has the potential to become the standard of care for Netherton patients and our goal is to make the product as widely available as possible via a combination of our own planned commercial infrastructure in the US and Europe as well as through our global distribution partnership network that now covers 60 countries.”
Quoin intends to self-commercialize QRX003 as well as other pipeline products in the United States and Europe, with robust plans for a successful rollout once approval has been granted. The combination of distribution partnerships and commercial infrastructure will enable Quoin to achieve global product launch, a key differentiator considering most peer companies focus solely on the U.S. market.
Quoin shares rose 4% on the news.