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

Vandana Singh
1 min read
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In this article:

  • Biopharmaceutical company Regulus Therapeutics Inc (NASDAQ: 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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