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Regulus Therapeutics Reports Second Quarter 2020 Financial Results and Recent Updates
Completion of Dosing in Phase 1 Multiple Ascending Dose Study (MAD) of RGLS4326 in Healthy
Volunteers for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
FDA Orphan Designation of RGLS4326 for ADPKD
Appointment of Denis Drygin, Ph.D., as Chief Scientific Officer
LA JOLLA, Calif., August 13, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the Company or Regulus), today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.
We are pleased with the progress of our ADPKD program and the completion of dosing of the MAD clinical study for RGLS4326 in healthy volunteers, said Jay Hagan, CEO of Regulus. We plan to initiate a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326 for safety, tolerability, pharmacokinetics, and changes in biomarkers of the disease. We have also recently completed additional non-clinical studies needed to address some of the FDA requirements to support studies of extended duration.
Second Quarter 2020 Corporate Highlights and Recent Updates
Appointment of Chief Scientific Officer: In August, Dr. Denis Drygin joined Regulus as its Chief Scientific Officer.
RGLS4326 for Autosomal Dominant Polycystic Kidney Disease: In July, 2020 the Company completed dosing in the MAD clinical study for RGLS4326 in healthy volunteers. The Phase 1 MAD study is a randomized, double blind, placebo-controlled clinical trial evaluating three different dose levels of RGLS4326 for safety, tolerability and pharmacokinetic properties. Top-line results showed that RGLS4326 is well-tolerated with no serious adverse events reported. Preliminary results suggest plasma exposure is dose proportional. In July, 2020 the FDA granted Orphan Drug Designation to RGLS4326 for ADPKD. The Company plans to initiate a Phase 1b open-label, short-term multiple dose study in patients with ADPKD in the second half of 2020. The study will evaluate RGLS4326 for safety, pharmacokinetics, and changes in levels of polycystin 1 (PC1) and polycystin 2 (PC2). Patients with ADPKD, due to the mutation in the PKD gene, have been reported to have low levels of PC1 and PC2. This study is designed to evaluate whether different dose levels of RGLS4326 can increase levels of PC1 and PC2 in ADPKD patients.
Advancement of Hepatitis B virus (HBV) Program: The Company has identified several microRNA targets that serve as host factors for the hepatitis B virus (HBV). Our lead compound directed to one of the host microRNAs has demonstrated nanomolar potency against HBV DNA replication and more than 95% reduction in Hepatitis B surface antigen in in vitro studies. Additionally, we have demonstrated reduction of HBV DNA, surface antigen and pgRNA in an in vivo efficacy model. We believe that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. We have nominated a development candidate and plan to commence IND-enabling activities.
The following information was filed by Regulus Therapeutics Inc. (RGLS) on Thursday, August 13, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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