REGULUS THERAPEUTICS INC.

(RGLS)
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Delayed Nasdaq  -  05/20 04:00:01 pm EDT
0.2261 USD   +7.62%
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Regulus Therapeutics Inc. Announces Successful Completion of Pre-Ind Meeting with FDA for Rgls8429

01/20/2022 | 05:18pm EDT

Regulus Therapeutics Inc. announced that the Company has completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to obtain input from the FDA on pre-clinical, clinical and regulatory matters pertaining to the Company's next generation compound RGLS8429 as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The formal minutes from this meeting were received by the Company earlier this week. The successful completion of this interaction with the FDA is an important milestone that provides regulatory clarity regarding Regulus' planned Phase 1 trial design. The agency provided overall agreement with the trial design and length of the Phase 1 study, including the proposed starting dose for RGLS8429, as well as sufficiency of the non-clinical package, with no commentary regarding its first-generation compound, RGLS4326 and any additional filing requirements. Based on the minutes, the Company is on track to submit an IND application in the second quarter of 2022 to obtain clearance for initiation of the Phase 1 clinical trial. The Phase 1 study will consist of two parts. Part 1 will consist of a single-ascending dose (SAD) study in healthy volunteers to assess safety and tolerability of RGLS8429 and characterize the pharmacokinetics of RGLS8429. A total of 32 subjects will be randomized to RGLS8429 or placebo into one of four sequential cohorts. The proposed doses for the four cohorts are 1 mg/kg, 2 mg/kg, 4 mg/kg, and 6 mg/kg. Part 2 will be a multiple ascending dose (MAD) study in adult patients with ADPKD to assess safety and tolerability of RGLS8429, to characterize the pharmacokinetics of RGLS8429, and to evaluate the dose response of RGLS8429 treatment on disease parameters in ADPKD patients including levels of the disease biomarker, polycystin, cystic kidney volume (htTKV), and overall kidney function. A total of 36 subjects will be randomized to RGLS8429 or placebo into one of three sequential cohorts. The proposed doses for the three cohorts are 0.75 mg/kg, 1.5 mg/kg, and 3 mg/kg every other week for three months. Regulus' updated clinical plans agreed to with FDA include extending dosing to three months in each cohort of ADPKD patients, inclusion of measurements of changes in htTKV by Magnetic Resonance Imaging (MRI), and testing higher doses of RGLS8429 than were tested with the first-generation compound. Height-adjusted total kidney volume (htTKV), a measure of cystic kidney volume, is a biomarker for disease severity and progression to kidney failure in patients with ADPKD. Increased htTKV has been found to occur prior to loss of kidney function, typically by years or decades, and retrospective evidence from published clinical studies has shown a correlation between reduction in TKV and reduction in the rate of decline in renal function.


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Financials (USD)
Sales 2022 - - -
Net income 2022 -28,6 M - -
Net Debt 2022 - - -
P/E ratio 2022 -1,16x
Yield 2022 -
Capitalization 33,0 M 33,0 M -
Capi. / Sales 2022 -
Capi. / Sales 2023 15,8x
Nbr of Employees 25
Free-Float 94,7%
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Number of Analysts 3
Last Close Price 0,23 $
Average target price 1,50 $
Spread / Average Target 563%
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Managers and Directors
Joseph P. Hagan President, Chief Executive Officer & Director
Crispina Calsada Chief Financial Officer
Stelios Papadopoulos Chairman
Denis Drygin Chief Scientific Officer
David Baltimore Independent Director
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