Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

The key findings include:

  • LGD-4033 was well tolerated by healthy male volunteers after single oral doses up to 22 mg, the highest dose tested. No serious adverse events (SAE) or clinically significant dose-related adverse events were reported.
  • Systemic exposure of LGD-4033 increased proportionally with the dose level after a single oral dose. Sustained systemic exposure was observed with appreciable plasma levels of LGD-4033 detectable a week post-dose. LGD-4033's half-life was consistent with a regimen of once-daily oral dosing.

According to Martin D. Meglasson, Ph.D., Ligand's Vice President of Discovery Research, "This study with LGD-4033 shows encouraging safety and pharmacokinetic data in humans consistent with once-daily oral dosing. Based on this favorable profile, a Phase I multi-dose clinical trial is being conducted. SARMs are promising drugs to treat the serious problem of muscle wasting that occurs in patients with a variety of disorders including frailty, cachexia and sarcopenia in the elderly."

Source Ligand Pharmaceuticals

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