Regulus Therapeutics (RGLS) said Thursday it has completed its phase 1b clinical trial of farabursen for the treatment of autosomal dominant polycystic kidney disease, with full data from the fourth cohort confirming the 300mg fixed dose selection to achieve optimal kidney exposure.
The company said that over four months, patients treated with 300 mg farabursen experienced a mean halting in the growth of height-adjusted total kidney volume, which has been shown to inversely correlate with kidney function.
The final efficacy data, together with the previously announced favorable safety and tolerability profile, confirm that 300 mg is appropriate for the phase 3 pivotal trial, the company said.
The company said it is on track to start the phase 3 single pivotal trial in Q3.
Shares of Regulus Therapeutics rose 55% in recent trading Thursday.
Price: 2.00, Change: +0.71, Percent Change: +54.96
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