Sequana Medical reported positive top-line results from its SAHARA Phase IIa study of DSR 1.0, involving 10 evaluable patients with diuretic-resistant heart failure. Results from these patients, who had completed the 16-week follow-up period (the second phase of the study, see our recent outlook note for details on study phases and design) following intensive DSR therapy, were largely consistent with the interim data reported in July. These patients reported a mean 33% reduction in NT-proBNP at this time point versus baseline (indicating improved cardio-renal status) and stable renal function (no significant change in eGFR versus baseline). Importantly, the need for loop diuretics medication was substantially reduced for many (at least six to 15) months following the first phase (intensive DSR therapy) of SAHARA, with nine out of 10 patients having had a reduction of more than 90% of their required dosing. Sequana is now advancing its second-generation DSR 2.0 product, designed to provide improved therapeutic and safety profiles and a longer dwell time. It has successfully dosed the first patient with DSR 2.0 in the Canadian Phase I study (YUKON), and aims to start the multi-centre randomised US MOJAVE Phase I/IIa study in DSR 2.0 in H123.
