Regulus Therapeutics Inc. (RGLS) shares gained 15.69% to $1.92 in Monday’s early session after reporting positive clinical trial results. A recent 5-day performance of 24.44% has been achieved by RGLS stock, which gained 5.00% last trading session to finish at $1.68.
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RGLS has shared what data?
Today, Regulus Therapeutics (RGLS) announced that its Phase 1 SAD clinical trial of RGLS8429 has shown positive topline safety and PK results. Furthermore, RGLS announced that its Phase 1b MAD clinical trial of RGLS8429 had been initiated.
SAD Phase 1 Study Results Summary
RGLS8429 was found to have favorable safety and PK profile in the Phase 1 SAD study. As far as adverse events were concerned, RGLS8429 was well-tolerated. RGLS8429 or placebo was administered to 32 subjects. Nine adverse events occurred, all of which were mild, with one (sinus infection) graded moderately severe. Plasma levels are dose-proportional across the four dose tests and are similar to first-generation RGLS4326 PK data.
Initiation of Phase 1b of MAD Study
ADPKD patients are enrolled in the phase 1b MAD study under a double-blind, placebo-controlled design.
- In the MAD study, the safety, tolerability, and pharmacokinetics of RGLS8429 will be evaluated.
- The efficacy of RGLS8429 will also be evaluated across three different dose levels, including changes in polycystin levels, cystic kidney volume, and kidney function as a whole.
- Initially, a dose level of 1 mg/kg every other week for three months will be tested in patients with ADPKD.
- It is expected that the first cohort of patients will produce top-line data in the first half of 2023.
How the outcome will help RGLS move further?
The safety and PK data generated in its Phase 1 SAD trial are highly encouraging and allow Regulus Therapeutics (RGLS) the flexibility to use a range of dose levels as RGLS explores the safety and efficacy of RGLS8429 in the Phase 1b MAD study. With the initiation of the MAD study, RGLS anticipates presenting top-line data from the first cohort of patients in the first half of 2023.