Followers | 1318 |
Posts | 26925 |
Boards Moderated | 6 |
Alias Born | 12/10/2012 |
Friday, January 07, 2022 7:35:41 AM
Hepion Pharmaceuticals Announces USAN Selection of Rencofilstat as Nonproprietary Name for CRV431
4:15 PM ET 1/6/22 | GlobeNewswire
Hepion Pharmaceuticals Announces USAN Selection of "Rencofilstat" as Nonproprietary Name for CRV431
EDISON, N.J., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and other liver diseases, today announced the United States Adopted Names ("USAN") Council has adopted the nonproprietary name "rencofilstat" for the Company's lead drug candidate, CRV431.
The USAN Council (tri-sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmacists Association) works closely with the International Nonproprietary Name Programme of the World Health Organization and various national nomenclature groups to achieve global standardization and unification of drug nomenclature and related rules with the goal of ensuring that drug information is communicated accurately and unambiguously.
Going forward, Hepion will use the name "rencofilstat" in upcoming publications and public statements, at conferences and other forums, as the Company continues to advance the drug's clinical development.
About Hepion Pharmaceuticals
The Company's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies. In November 2021, the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for rencofilstat for the treatment of NASH. That was soon followed in December 2021 by the FDA's acceptance of Hepion's investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform, called AI-POWR(TM), which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR(TM) to help identify which NASH patients will best respond to encoflistat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR(TM) to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for encoflistat to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
> Dow Jones Newswires
January 06, 2022 16:15 ET (21:15 GMT)
Recent HEPA News
- Pharma Two B and Hepion Pharmaceuticals, Inc. Announce Filing of Registration Statement on Form F-4 Related to Proposed Merger • GlobeNewswire Inc. • 09/04/2024 01:25:00 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/07/2024 01:08:47 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 01:04:30 PM
- Pharma Two B Announces Plans to Go Public via Merger with Hepion Pharmaceuticals, Inc. and Concurrent $11.5 Million Private Placement • GlobeNewswire Inc. • 07/22/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/21/2024 09:08:39 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 08:46:12 PM
- Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial • GlobeNewswire Inc. • 04/19/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 02:02:26 PM
- Hepion Pharmaceuticals Announces Exercise of Warrants for Approximately $2.0 Million Aggregate Gross Proceeds • GlobeNewswire Inc. • 02/16/2024 01:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:57 PM
- Hepion Pharmaceuticals to Present at NASH-TAG 2024 • GlobeNewswire Inc. • 01/03/2024 10:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/03/2024 09:30:24 PM
- Hepion Pharmaceuticals Announces Restructuring Plan to Enhance Shareholder Value and Management Changes • GlobeNewswire Inc. • 12/07/2023 01:00:00 PM
- Hepion Pharmaceuticals to Present at the 7th Obesity & NASH Drug Development Summit • GlobeNewswire Inc. • 11/28/2023 09:15:00 PM
- Hepion Pharmaceuticals Announces Major Reductions in Liver Stiffness with Rencofilstat Treatment in 17-week Phase 2 Study of Advanced (F3) MASH Liver Disease • GlobeNewswire Inc. • 11/13/2023 09:05:00 PM
- Hepion Pharmaceuticals Schedules Conference Call to Review Additional Efficacy Data from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat • GlobeNewswire Inc. • 11/10/2023 01:50:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/09/2023 05:15:08 AM
- Hepion Pharmaceuticals’ Rencofilstat Demonstrates Anti-Cancer Activity in Hepatitis C-Associated Cancer Model • GlobeNewswire Inc. • 10/25/2023 12:30:00 PM
- Hepion Pharmaceuticals Announces $5.0 Million Registered Direct Offering and Concurrent Private Placement Priced At-The-Market under Nasdaq Rules • GlobeNewswire Inc. • 09/29/2023 12:00:00 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM