HighTide integrates expertise in disease biology, medicinal chemistry, clinical development and regulatory affairs to advance its growing pipeline of drugs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity. HighTide’s continued clinical progress with HTD1801 includes an ongoing Phase 2 study for the treatment of type 2 diabetes (T2DM), the initiation of a global Phase 2b study for the treatment of nonalcoholic steatohepatitis (NASH), and the successful end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) for primary sclerosing cholangitis (PSC). The U.S. FDA has granted HTD1801 Fast Track designation in both NASH and PSC.
Hypertriglyceridemia (HTG) is a common form of a lipid disorder with a fasting plasma triglyceride (TG) above 150 mg/dL. Patients with severe hypertriglyceridemia (SHTG) have triglyceride levels more than three times the normal level, i.e. >500 mg/dL.