Shares of Regulus Therapeutics RGLS increased 16.87% during market hours on Sep 12 after the company announced positive top-line safety and pharmacokinetics data from its phase I single ascending dose (SAD) study of its lead product candidate RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD).
However, Regulus Therapeutics’ shares have declined 38.4% in the year-to-date period compared with the industry’s fall of 21.1%.
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ADPKD is an inherited monogenic renal disorder caused by mutations in the PKD1 or PKD2 genes, characterized by the development of multiple fluid-filled cysts, primarily in the kidneys and sometimes even in the liver and other organs. In the United States, approximately 160,000 individuals are diagnosed with ADPKD.
The FDA accepted the investigational new drug (IND) application for RGLS8429 in May 2022. Post the IND acceptance, the company initiated a phase I SAD study of RGLS8429 in June 2022.
The phase I study demonstrated a favorable safety and pharmacokinetic profile of RGLS8429 and was well-tolerated in the 32 subjects of the study, with no reported adverse event.
The preliminary results from the study showed that the plasma exposure across the four doses tested is proportional to each other and compared favorably with the pharmacokinetics data from the first-generation preclinical compound RGLS4326.
Following the positive results from the SAD study, the company initiated a phase Ib multiple-ascending dose (MAD) study in adults with ADPKD to evaluate the tolerability, safety and pharmacokinetics of RGLS8429. The MAD study will also evaluate the efficacy of the candidate across three different dose levels, including changes in polycystins, cystic kidney volume (htTKV) and overall kidney function.
Top-line data from the first cohort of patients in the MAD study is anticipated by the first half of 2023.
Regulus Therapeutics in a clinical-stage biopharma company focused on discovering and developing drugs targeting the microRNAs to treat diseases with significant unmet needs. Apart from RGLS8429, the company is also developing lademirsen (RG-012) in patients with Alport syndrome.
The company, under its collaboration with French pharma giant Sanofi SNY completed the enrollment in the phase II HERA study evaluating lademirsen for treating Alport syndrome in February 2022. In July, Sanofi terminated the HERA study due to the failure of the candidate to meet Sanofi’s pre-defined utility criteria.
Sanofi is evaluating various opportunities to develop RG-012.
Regulus Therapeutics Inc. Price
Regulus Therapeutics Inc. price | Regulus Therapeutics Inc. Quote
Zacks Rank and Stocks to Consider
Regulus Therapeutics currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector are Acer Therapeutics ACER and Aerie Pharmaceuticals AERI, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acer Therapeutics’ loss per share estimates for 2022 have improved from $3.47 to $2.47 in the past 30 days. The same for 2023 has improved from $1.49 to $1.07 in the same time frame.
Earnings of Acer missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average negative earnings surprise for ACER is 106.16%.
Aerie’s loss per share estimates for 2022 has remained steady at $1.83 in the past 30 days. The same for 2023 has remained steady at $1.01 in the same time frame.
Earnings of Aerie beat estimates in three of the trailing four quarters while missing the same in the remaining occasion. The average earnings surprise for AERI is 70.27%.
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