QNRX: Protocol Modifications Potentially Accelerate, Expand QRX003 Approvals

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By M. Marin

NASDAQ:QNRX

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Protocol modifications could accelerate and/or expand QRX003 regulatory approvals …

Quoin Pharmaceuticals (NASDAQ:QNRX) has two active Netherton Syndrome (NS) studies that are being conducted concurrently to evaluate lead asset QRX003 for the treatment of NS. Preliminary clinical data was positive. Five of 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. Moreover, all six subjects had positive impressions of QRX003 on multiple metrics that were assessed.

Company optimistic that QRX003 on-track to be 1st approved treatment for NS

Following the initial positive clinical data, the company implemented several protocol amendments to its clinical program to optimize its clinical effort. The company believes these protocol modifications could potentially result in accelerating and/or expanding regulatory approvals for QRX003. With the upsize in the number of participants for the two studies, Quoin will test an aggregate of 50 NS subjects. Quoin is optimistic that once both clinical studies conclude, the data could be sufficient to support an NDA filing so that additional clinical studies in NS subjects will not be necessary. The company is optimistic that QRX003 remains on-track to become the first regulatory approved treatment for Netherton Syndrome.

Strategy to assess assets for multiple indications, can help spread costs over expanded base…

The company’s strategy is to assess its products for multiple indications, which in turn can help spread R&D and other costs over an expanded base. Thus, as Quoin’s products are being designed to treat multiple indications, lead asset QRX003 is planned to target NS initially, as noted, and Quoin also intends to expand its use to other patient populations. This strategy is expected to broaden QRX003’s overall target patient populations and commercial prospects, create operating and cost efficiencies and scale and enhance the commercial opportunities of QRX003 and other drugs in the product pipeline.

Moreover, through a recent capital raise and an arrangement for an equity line of credit for up to $8 million, management believes that through these measures, it has extended its cash to maintain activities into late 2025. This is expected to enable Quoin to continue moving QRX003 ahead through the dual NS clinical trials.