CymaBay Therapeutics Inc. (NASDAQ: CBAY) posted a huge gain to start the week after the company reported results from a late-stage clinical study for the treatment of primary biliary cholangitis (PBC). Although PBC is not a household name, CymaBay has found an effective treatment for the disease, and investors are cheering it on.
The firm announced positive topline results from its Phase 3 Enhance study evaluating the safety and efficacy of seladelpar for the treatment of PBC. Seladelpar has demonstrated anti-cholestatic and anti-inflammatory effects in clinical studies for PBC.
PBC is an autoimmune disease that causes progressive destruction of the bile ducts. Bile is produced by the liver to facilitate digestion.
Ultimately, seladelpar achieved the primary outcome with high statistical significance in 78.2% of patients in the 10 mg dose group and 57.1% in the 5 mg dose group, compared to 12.5% in the placebo group, after three months.
Separately, seladelpar demonstrated a strong, dose-dependent reduction in pruritus after just three months of treatment.
Treatment also demonstrated robust anti-inflammatory activity at three months with mean alanine aminotransferase (ALT) decreases of 17% in the 10 mg group versus 3% in the placebo group. The effect of seladelpar treatment on gamma-glutamyl transferase (GGT) also was highly significant with a decrease of 36% in the 10 mg group, compared to 7% in the placebo group. ALT and GGT are enzymes that increase in the blood when the liver is damaged.
Management even noted that data from this study demonstrated that seladelpar appears safe and well tolerated, and the efficacy demonstrated points to the potential for seladelpar to be a best-in-class treatment alternative for patients with PBC.
CymaBay Therapeutics stock traded up about 34% to $4.74 on Monday, in a 52-week range of $1.21 to $6.56. The consensus price target is $9.56.
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