Rhythm Pharmaceuticals updates clinical data from setmelanotide trial

Rhythm Pharmaceuticals announced updated clinical data from two adolescent patients in its Phase 2 basket studies evaluating setmelanotide for the treatment of BBS who previously had only short-term results. Data is now available for 47 and 41 weeks of treatment. These two patients have lost 11.2% and 15.5% of their body weight and experienced hunger score reductions of 66% and 21%, respectively. Treatment with setmelanotide continues to be well tolerated and safety data were consistent with previous clinical studies. In total, six out of nine BBS patients enrolled in the Phase 2 basket studies have now achieved a clinically meaningful weight loss of 10% change from baseline, which is the primary endpoint for the company’s pivotal Phase 3 clinical trial, and, as previously reported, one additional patient with Type-1 diabetes responded with marked improvements in hunger score and blood sugar levels. In December 2018, Rhythm began treating patients in a combined pivotal Phase 3 clinical trial evaluating setmelanotide in BBS and Alstrom Syndrome and expects to complete pivotal enrollment of at least 20 patients with BBS and at least six patients with Alstrom Syndrome in the second half of 2019.

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