Xphozah’s approval was based on data from three Phase III clinical trials. Image Credit: Maxx-Studio / Shutterstock.

The US Food and Drug Administration (FDA) approved Ardelyx’s Xphozah (tenapanor) as an add-on therapy for CKD patients on dialysis who are either intolerant of or have an inadequate response to phosphate binders.

Xphozah is a phosphate absorption inhibitor which reduces serum phosphorus levels by blocking its absorption. It is administered as an oral tablet twice a day. The drug’s path to approval has been a tumultuous one. In July 2021, the FDA rejected Xphozah’s new drug application (NDA). After a successful appeal, the company filed a new NDA in April 2023.

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Alongside the approval, Ardelyx secured an additional $50m in debt financing from SLR Capital Partners to finance the launch of Xphozah, based on a 17 October press release. The funds will also be invested into the US commercialisation of the company’s irritable bowel with constipation therapy Ibsrela (tenapanor).

The US-based company entered the arrangement for interest-only funding with SLR in February 2022. The original agreement with SLR was for $50m in financing, $27.5 of which was withdrawn in February 2022. The remaining $22.5m is planned for withdrawal this month to fund the November 2023 launch of Xphozah, per the 17 October press release.

The current amendment allows for an additional $50m in funding to be drawn by 15 March 2024, with an option to borrow $50m in further financing. The interest-only period for the existing and new tranches has also been extended to 31 December 2026.

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Ardelyx added that it is under no obligation to withdraw funds in the future. All the capital from the facility matures on 1 March 2027. The company’s market cap stands at $751.627m.

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Xphozah’s approval was based on data from three Phase III clinical trials (NCT03427125, NCT02675998, and NCT03824587), based on a 17 October press release. The studies demonstrated Xphozah’s ability to decrease phosphorus levels both as a monotherapy and in combination with a phosphate binder.

Diarrhoea was the most common side effect associated with Xphozah. It occurred in 43%-53% of the patients and was mild to moderate in severity across the three trials. Severe diarrhoea was reported in 5% of the patients in all three trials.