Regulus Shares Surge After Early-Stage RGLS8429 Data In Rare Kidney Disease

  • Biopharmaceutical company Regulus Therapeutics Inc RGLS shares jumped after topline safety and Pharmacokinetic (PK) data from its Phase 1 single-ascending dose (SAD) trial of RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD). 
  • ADPKD is characterized by the development of multiple fluid-filled cysts, primarily in the kidneys.
  • The data exhibited that RGLS8429 has a favorable safety and PK profile. RGLS8429 was well-tolerated, with no serious adverse events reported. 
  • Related: Regulus Therapeutics Moves Forward With Next-Gen Compound, RGLS8429 In Kidney Disorder.
  • Among the 32 subjects treated with RGLS8429 or placebo, nine adverse events were mild, except one (sinus infection), graded moderate in severity. 
  • Preliminary results suggest plasma exposure is dose-proportional across the four doses tested.
  • The company initiated its Phase 1b Multiple Ascending Dose (MAD) trial of RGLS8429.
  • The first planned dose level to be tested in patients with ADPKD is 1 mg/kg dosed every other week for three months. 
  • Topline data from the first cohort of patients is expected in 1H 2023.
  • Price Action: RGLS shares are up 21.4% at $2.05 during the premarket session on the last check Monday.
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