Pathalys
Pathalys Pharma, Inc. is a private, clinical-stage biopharmaceutical company focused on addressing unmet needs in the management of end-stage kidney disease (ESKD). Their lead asset is upacicalcet, an intravenously administered small molecule calcimimetic that has the potential to control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving haemodialysis. Upacicalcet may enable ESKD patients to achieve better control of iPTH and blood calcium levels, lowering risk for potentially severe health consequences. Upacicalcet was granted Marketing Authorization in Japan in 2021 (brand name UPASITA®), based on two Phase 3 studies. In these studies, upacicalcet was shown to significantly reduce iPTH and maintain long-term iPTH suppression, as well as demonstrate the potential for fewer adverse events than currently available therapies. Launch Therapeutics is leading the operational execution and management of the planned clinical trials, and is working with Pathalys’ dialysis expertise to accelerate the company to regulatory approval in the U.S.
Launch Therapeutics will lead the operational execution and management of the planned clinical trials, and together with Pathalys’ dialysis expertise, will work to accelerate the company to regulatory approval in the US.