Sequana Medical - CHIHUAHUA results clear path to MOJAVE
Sequana Medical reported positive results from the CHIHUAHUA Phase I study of its second-generation DSR (direct sodium removal) product, DSR 2.0. This clears a key hurdle needed before filing a US Investigational New Drug (IND) application to start the MOJAVE US Phase I/IIa study in patients with diuretic-resistant congestive heart failure (CHF). CHIHUAHUA was conducted in 10 stable peritoneal dialysis (PD) patients in Mexico and showed that a single dose of DSR 2.0, administered via a PD catheter over a 24-hour dwell period, was safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events. The positive safety data, in combination with favourable preclinical results, should support the IND filing, in our view. The company continues to expect to file the IND application for DSR 2.0 in Q123 and, if accepted by the US FDA, it plans to start enrolment for MOJAVE in Q223. Sequana continues to anticipate reporting interim results in H223, and top-line data in H224.Sequana Medical NV. Sequana Medical NV is a Belgium-based company, which manufactures medical devices. The Company focuses mainly on the development of treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. Sequana Medical NV provides alfapump, which is an implantable, programmable, wireless-charged and battery-powered system that is CE-marking for the management of refractory ascites due to liver cirrhosis and malignant ascites. Over 650 alfapump systems have been implanted. Apart from the Alfapump, the Company also aims to develop a direct sodium removal (DSR) therapy, which is a propriety approach to the treatment of volume overload in heart failure.
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