Clene (NASDAQ: CLNN), a late-stage biopharmaceutical company focused on protecting mitochondrial health and neuronal function to treat neurodegenerative diseases, and its wholly owned subsidiary Clene Nanomedicine Inc., have submitted new data to the U.S. Food and Drug Administration (“FDA”). The data is regarding CNM-Au8(R) biomarker and clinical efficacy information, including post hoc analyses from two phase 2 clinical trials of CNM-Au8 for the treatment of ALS; the trials were conducted independently.
According to the announcement, this new data is in addition to original data the company has discussed with FDA and is intended to guide the planned FDA Type C interaction; that interaction is expected to take place in the Q3 2024 and will include discussion about an accelerated approval regulatory pathway.
Clene Nanomedicine is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”).
“The risk-benefit assessment evidence of CNM-Au8 is strong,” said Clene CEO and president Rob Etherington in the press release. “Our next step is discussing this new CNM-Au8 biomarker and efficacy data with the FDA, with the hope that ALS patients will benefit from this drug, sooner rather than later.”
To view the full article, visit https://ibn.fm/3oeW6
About Clene Inc.
Clene and its wholly owned subsidiary, Clene Nanomedicine, is a late-clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8(R) is an investigational, first-in-class therapy that improves the survival and function of central nervous system cells via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress. CNM-Au8 is a federally registered trademark of Clene Nanomedicine. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
About InvestorWire
InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.
For more information, please visit https://www.InvestorWire.com
Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer
InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
[email protected]
InvestorWire is powered by IBN