- 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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