Dicerna Announces Updated Phase 1 Data on RG6346 Investigational Treatment for Chronic Hepatitis B Virus to be Presented in Late-Breaking Session at AASLD’s The Liver Meeting® Digital Experience™ 2020
Dicerna Pharmaceuticals (Nasdaq: DRNA) announced updated data for RG6346, a GalXC™ RNAi therapeutic aimed at treating chronic hepatitis B virus (HBV) infection. This data will be presented at The Liver Meeting® 2020 from Nov. 13-16. The findings suggest RG6346 is safe, well-tolerated, and can lead to significant reductions in serum HBsAg levels, indicating its potential as a treatment option. The Phase 1b-2a trial highlights RG6346's promise in achieving functional cures compared to existing therapies.
- RG6346 demonstrates safety and tolerability during Phase 1b-2a trials.
- Substantial reductions in serum HBsAg levels indicate potential for a functional cure for chronic HBV.
- None.
LEXINGTON, Mass.--(BUSINESS WIRE)--Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that updated data related to RG6346, an investigational GalXC™ RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection, will be presented at The Liver Meeting® Digital Experience™ 2020, hosted by the American Association for the Study of Liver Diseases (AASLD), which will occur Nov. 13-16, 2020.
The abstract, titled, “HBV RNAi Inhibitor RG6346 in Phase 1b-2a Trial Was Safe, Well-Tolerated, and Resulted in Substantial and Durable Reductions in Serum HBsAg Levels,” will be the subject of both a late-breaking oral presentation and poster at the conference.
Session: Late-Breaking Oral Session 2
Date: Monday, Nov. 16, 2020
Time: Live presentation at 2:20 p.m. ET during oral session from 2:00-3:30 p.m. ET
Presenter: Man-Fung Yuen, D.Sc., M.D., Ph.D., Chair Professor & Endowed Professor in Medicine, Li Shu Fan Medical Foundation; Chief of the Division of Gastroenterology & Hepatology and Deputy Head of the Department of Medicine, Queen Mary Hospital, The University of Hong Kong
Session: On-Demand Poster Session
Date: Beginning Friday, Nov. 13, 2020 at 10:00 a.m. ET
The abstract can be found on the AASLD website by clicking this link.
The presentation and poster will be made available on the Events & Presentations page in the Investors & Media section of Dicerna’s website after the poster is made available on the AASLD website and after the oral presentation has begun.
About Chronic Hepatitis B Virus (HBV) Infection
Hepatitis B virus (HBV) is the world’s most common serious liver infection and affects an estimated 292 million people worldwide.1 According to the Hepatitis B Foundation, 30 million people become newly infected with HBV each year, and it is estimated that more than 880,000 people die annually from hepatitis B and related complications such as liver cancer.2
About RG6346
RG6346 is an investigational GalXC™ RNAi therapeutic candidate in development in collaboration with Roche for the treatment of chronic HBV infection. Dicerna is currently conducting a Phase 1 proof-of-concept trial of RG6346 in adult patients with non-cirrhotic chronic HBV infection. Current therapies for HBV, such as nucleoside analogs, can provide long-term viral suppression if taken continuously, but they rarely lead to long-term functional cures, as measured by the clearance of HBV surface antigen (HBsAg) and sustained HBV deoxyribonucleic acid (DNA) suppression in patient plasma or blood. By contrast, RG6346 is designed to employ RNAi to knock down selectively specific genes involved in the creation of HBV messenger RNA (mRNA) and the entry of the virus into liver cells. Preclinical data have demonstrated greater than
About Dicerna Pharmaceuticals, Inc.
Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference (RNAi) to silence selectively genes that cause or contribute to disease. Using our proprietary RNAi technology platform called GalXC™, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on hepatocytes, Dicerna has continued to innovate and is exploring new applications of its RNAi technology beyond the liver, targeting additional tissues and enabling new therapeutic applications. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH and Alnylam Pharmaceuticals, Inc. Between Dicerna and our collaborative partners, we currently have more than 20 active discovery, preclinical or clinical programs focused on rare, cardiometabolic, viral, chronic liver and complement-mediated diseases, as well as neurodegeneration and pain. At Dicerna, our mission is to interfere – to silence genes, to fight disease, to restore health. For more information, please visit www.dicerna.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements pertaining to the Company’s presentation of clinical results related to RG6346, as well as our business and operations, including the discovery, development and commercialization of our product candidates and technology platform, and the therapeutic potential thereof, the success of our collaboration with partners and any potential future collaborations and our strategy, business plans and focus. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those risks identified under the heading “Risk Factors” included in our most recent Form 10-Q filing and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Dicerna's current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.
GalXC™ is a trademark of Dicerna Pharmaceuticals, Inc. The Liver Meeting® Digital Experience™ are trademarks of the American Association for the Study of Liver Diseases.
1 Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. The Lancet Gastroenterology and Hepatology. 2018;3(6):383-403.
2 Hepatitis B Foundation. Facts and Figures. Available at: http://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/. Accessed on Oct. 25, 2020.
