Regulus Therapeutics to Present at the H.C. Wainwright 22nd Annual Virtual Global Investment Confer | RGLS Message Board Posts

Regulus Therapeutics Inc.

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Msg  626 of 629  at  9/15/2020 11:36:06 AM  by

Dendrimer


 In response to msg 625 by  Steve_382
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Re: Regulus Therapeutics to Present at the H.C. Wainwright 22nd Annual Virtual Global Investment Conference

Thanks for posting Steve. Interesting trial design. Normally they start with a low dose and go higher. Did they explain this design on the call?

“Cohorts will be enrolled and treated sequentially. Dosing decisions will be made based on prior cohort's safety and biomarker data. Six to 9 subjects will be enrolled in each cohort based on the magnitude and/or variability of the increase in PC1 and PC2 or to allow for replacement of subjects that do not complete the study. The highest dose (1 mg/kg) will be administered in cohort 1. If the Sponsor determines that the increase in PC1 and PC2 from baseline for cohort 1 is inadequate, the study may be stopped for futility. If the Sponsor determines that the increase from baseline for cohort 1 is adequate, then 0.3 mg/kg will be administered in cohort 2. Based on the increase of PC1 and PC2 from baseline in cohort 2, Sponsor may determine a higher dose needs to be evaluated, then 0.5 mg/kg will be administered in cohort 3. If the Sponsor determines that lower dose needs to be evaluated, then 0.1 mg/kg will be administered in cohort 3.”


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627 Re: Regulus Therapeutics to Present at the H.C. Wainwright 22nd Annual Virtual Global Investment Conference Steve_382 0 9/15/2020 4:56:40 PM






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