QNRX: Planned Protocol Modifications Might Accelerate QRX003 Regulatory Approval
By M. Marin
NASDAQ:QNRX
READ THE FULL QNRX RESEARCH REPORT
Planned protocol modifications could accelerate & possibly expand regulatory approvals for QRX003
Positive clinical data from the first 6 patients in Quoin Pharmaceuticals’ (NASDAQ:QNRX) QRX003 open-label trial for treatment of Netherton Syndrome (NS) has led to planned protocol amendments, including eliminating the lower 2% dose in the double blinded study based on the clean safety profile observed for the 4% dose, increasing dosing frequency to twice-daily and increasing the number of subjects in both studies. Quoin expects these modifications can further optimize its clinical efforts.
The company has two active NS studies that are being conducted concurrently. As both trials utilize the same investigators and clinical sites, Quoin expects to garner substantial operational synergies and cost savings. Quoin believes it is the only development company conducting dual NS studies concurrently under an open IND application. To-date, no safety concerns have been reported for any patient enrolled in either study.
Source: Company Presentation
Specifically, last month Quoin announced positive clinical data from the first six patients in the open-label trial. Five of the six subjects evaluated had negligible or absent pruritus (itch) following treatment with QRX003, which represents a substantial improvement for these patients compared to before the study even though all of the subjects enrolled have received off-label systemic treatment for at least one year and/or multiple years. In terms of the Investigator assessed skin scoring system, all six subjects showed improvement. Of the six, three exhibited improvement throughout the study and three at various times over the course of the study. Moreover, all six subjects had positive impressions of QRX003 on multiple metrics that were assessed.
Expanding sales infrastructure; New licensing deal for Singapore
As Quoin prepares for the expect commercialization of QRX003 and other therapies, the company is developing an internal sales / distribution infrastructure to cover the U.S. and Europe and has entered into partnerships, for international markets. Quoin recently entered into an exclusive license and distribution agreement with Switzerland-based Farma Mondo SA, granting Farma Mondo an exclusive license to commercialize QRX003 in Singapore, once regulatory approvals have been attained. Over the past several quarters, Quoin has established a global commercialization and distribution network encompassing at least 60 countries.
Potential M&A transaction to complement and enhance current product pipeline
Quoin also continues to seek rare / orphan disease assets that management believes would complement and enhance its current product pipeline. Having evaluated more than 20 different potential opportunities recently, the company has narrowed its potential M&A list down to three products for which the company has reached agreement on key financial terms in order to move forward towards a possible transaction. Management noted, however, that current market and economic uncertainty, as well as the interest rate environment, might cause delays in consummating a potential transaction or even result in not closing a deal at all.
Cash position expected to support clinical efforts through YE24
Nevertheless, the company hopes to close at least one transaction as quickly as it can. The company reiterated its goal of conserving its current cash position to advance its clinical efforts for the ongoing programs and therefore would not expect to close a transaction unless it can raise funds to support expanded clinical development activities. With about $14 million in cash & investments, Quoin believes it has sufficient capital to maintain its growth strategy through the end of 2024.
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