Type: Sulfated oxysterol designed to epigenetically modify gene activity without changing the DNA sequence itself. The endogenous, orally bioavailable small molecule has been shown to modulate the activity of nuclear receptors playing an important regulatory role in cellular functions such as lipid homeostasis, inflammation, and cell survival. DUR-928 is the lead product candidate in DURECT’s Epigenetic Regulator program
Status: DURECT said September 23 that it dosed the first patient in a randomized, double-blind, placebo-controlled, multi-center Phase II trial (NCT04447404) designed to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury.
A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The trial’s primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days.
DUR-928 has also shown positive efficacy and safety in a Phase IIa trial in alcoholic hepatitis (AH), via intravenous administration, as well as encouraging topline data in a Phase 1b trial in nonalcoholic steatohepatitis (NASH), via oral administration.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: