- The shares of clinical-stage biotech Regulus Therapeutics Inc. (NASDAQ:RGLS) climbed ~15% in the pre-market trading Monday after the company announced topline data from its Phase 1 Single-Ascending Dose (SAD) trial for kidney disease candidate RGLS8429.
- RGLS8429, designed to target Autosomal Dominant Polycystic Kidney Disease (ADPKD), belongs to a drug class known as oligonucleotides.
- The topline safety and pharmacokinetics data from the study involving healthy volunteers indicated that RGLS8429 was well-tolerated with no serious adverse events, RGLS said.
- Among 32 patients who received the therapy, there were nine adverse events, out of which only one (sinus infection) was found to be moderate in severity.
- With the data update from the SAD portion of the study, the company announced the launch of the Phase 1b Multiple Ascending Dose (MAD) study for the candidate, which involves ADPKD patients. The topline data from the first cohort of patients are expected in 1H 2023.
Read: Seeking Alpha contributor Bret Jensen takes a deep dive into RGLS with a Hold rating on the stock.