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Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
Clene Inc. (NASDAQ: CLNN) is set to announce topline results for its CNM-Au8® regimen in the HEALEY ALS Platform Trial on October 3, 2022. Following the release, Clene's management will host a conference call and webcast at 8:30 a.m. EDT to discuss findings. CNM-Au8®, an oral suspension of gold nanocrystals, aims to enhance neuronal health by facilitating energy production, targeting conditions like multiple sclerosis and amyotrophic lateral sclerosis. Investors can access the webcast through the company’s website.
Clene Inc. (Nasdaq: CLNN) announced significant findings from the Phase 2 RESCUE-ALS trial, indicating that treatment with CNM-Au8 reduced the risk of mortality by approximately 70% compared to placebo. The updated analyses, presented at the 2022 AANEM Conference, revealed that the treatment was well-tolerated with no significant safety concerns. These results support CNM-Au8's potential as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Clene also aims to advance CNM-Au8's development in other neurodegenerative diseases.
SALT LAKE CITY, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) announced its participation in two upcoming investor conferences in September 2022. The first is Citi’s 17th Annual BioPharma Conference on September 8, 2022, in Boston, followed by H.C. Wainwright's 24th Annual Global Investment Conference on September 12-13, 2022, in New York. Clene's lead asset, CNM-Au8, is a treatment for multiple sclerosis and amyotrophic lateral sclerosis that enhances neuronal health through gold nanocrystals. More information can be found on their website.
Clene Inc. (Nasdaq: CLNN) announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8, an investigational treatment for relapsing multiple sclerosis (RRMS). The trial met its primary endpoint, showing significant improvements in Low Contrast Letter Acuity (LCLA) and the modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks compared to placebo. CNM-Au8 was well-tolerated, with no significant safety issues noted. These results support advancing CNM-Au8 into Phase 3 development, addressing critical needs in MS treatment.
Clene Inc. (Nasdaq: CLNN) reported positive topline results from its Phase 2 VISIONARY-MS trial with CNM-Au8®, showing significant improvements in Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks. In addition, open-label results from the RESCUE-ALS trial indicated a significant reduction in mortality (5 CNM-Au8 deaths vs. 14 placebo deaths). As of June 30, 2022, cash reserves were $26.3 million. Clene has also received European Orphan Drug Designation for CNM-Au8 in ALS, with further clinical data expected this quarter.
Clene Inc. (NASDAQ: CLNN) will present results from its Phase 2 VISIONARY-MS trial on August 15, 2022, at 7:30 a.m. EDT. The trial focuses on CNM-Au8, an oral suspension aimed at improving neuronal health in neurodegenerative diseases. Interested investors can join via conference call at 1 (888) 770-7152 using Conference ID: 5318408, or access a live audio webcast on the company's website for further insights into the clinical outcomes and implications for treatment.
Clene Inc. (Nasdaq: CLNN) has received a positive opinion from the European Medicines Agency for Orphan Drug Designation for CNM-Au8® aimed at treating amyotrophic lateral sclerosis (ALS). This designation, granted for serious conditions affecting fewer than 5 in 10,000 individuals, will provide Clene with regulatory benefits, including reduced fees and market exclusivity. The decision was based on data from the Phase 2 RESCUE-ALS trial, showing a statistically significant survival benefit. The company plans to expedite CNM-Au8's availability to ALS patients.
Clene Inc. (Nasdaq: CLNN) has reported promising results from its RESCUE-ALS trial, showing that patients treated with CNM-Au8 experienced significantly improved survival rates compared to those receiving a placebo. The trial indicated a 70% reduction in the risk of death for the CNM-Au8 group, based on Kaplan-Meier survival analysis (HR=0.301, p=0.0143). The treatment was also well-tolerated with no major safety issues noted. Clene anticipates releasing further data from the larger HEALEY ALS Platform Trial, aiming to confirm and expand on these promising findings.
Clene (NASDAQ: CLNN) announced that President and CEO Rob Etherington will join a virtual panel on ALS treatments, hosted by Maxim Group on June 28 at 11 a.m. EDT. The discussion will address the urgent need for new therapies for amyotrophic lateral sclerosis (ALS), as current options are limited. Clene's lead candidate, CNM-Au8®, is in late-stage trials, with topline data expected in Q3 from a Phase 2/3 study. This drug aims to restore neuronal health with gold nanocrystals, enhancing energy production and offering neuroprotection.
Clene Inc. (NASDAQ: CLNN) has announced its support for Lou Gehrig Day, marking the occasion by broadcasting a message on the Nasdaq MarketSite tower in Times Square. This initiative enhances awareness for ALS, a disease that Gehrig famously battled. Former Yankees outfielder Chris Dickerson will feature in the message, emphasizing commitment to ALS research and treatment. Clene is focused on new therapies and anticipates topline results from its Phase 2/3 clinical trial for its lead drug candidate, CNM-Au8, in the upcoming quarter.