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The Science

We Aim to Help Address the Complexities of Uncontrolled SHPT

Pathalys is developing upacicalcet, an investigational small molecule calcimimetic that acts as a positive allosteric modulator.¹ It is thought to activate CaSR in the presence of extracellular calcium, with little agonist activity when calcium falls below the physiologic range.²

Upacicalcet is an investigational product candidate in the United States and has not been approved by the U.S. Food and Drug Administration (FDA).

One such initial area of focus for Pathalys is exploring new options for treating secondary hyperparathyroidism (SHPT).

SHPT is a common complication of chronic kidney disease in patients receiving dialysis, developing as the body struggles to maintain healthy calcium, phosphorus and parathyroid hormone levels when kidney function is lost.

About SHPT

Pathalys has completed two Phase 3 clinical programs to evaluate the efficacy and safety of upacicalcet in patients with hemodialysis-dependent end stage kidney disease and secondary hyperparathyroidism (SHPT).

PATH-1
NCT05832931Upward arrow indicating an external link

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

A Phase 3 randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of dose-titrated PLS240 in the treatment of secondary hyperparathyroidism in individuals with end stage kidney disease on hemodialysis (PATH-1) with an open-label extension.

PATH-2
NCT05836220Upward arrow indicating an external link

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

A Phase 3 randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of dose-titrated PLS240 in the treatment of secondary hyperparathyroidism in individuals with end stage kidney disease on hemodialysis (PATH-2) with an open-label extension.

References
  1. Sato H, etal. Mol Pharmacol. 2022;102(4):183-195.
  2. Goto M, etal. Eur J Pharmacol. 2023;956:175936

A new path for patients with Chronic Kidney Disease

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4000 Center at North Hills Street
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Raleigh, NC 27609
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