Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

  • Treatment with CNM-Au8 significantly improved long-term survival with   approximately a 70% decreased risk of mortality vs. original placebo randomization
  • Comparable survival benefits were also shown   compared to ENCALS predicted median survival
  • C   NM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.

The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension   ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .

"These clinical and survival data from RESCUE-ALS contribute to the growing body of evidence supporting the potential for CNM-Au8 as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS)," said Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer.

Rob Etherington, Clene's CEO, added, "The impressive ALS survival benefits seen with CNM-Au8 treatment corroborate our thesis – energetic support of neurons may protect CNS health and slow neurodegenerative disease progression. We look forward to upcoming results from the HEALEY ALS Platform Trial and advancing CNM-Au8 development in ALS and other neurodegenerative diseases, including multiple sclerosis and Parkinson's."

About Rescue-ALS
RESCUE-ALS, a Phase 2 multi-center, randomized, double-blind, parallel-group, placebo-controlled trial, examined the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in 45 participants (73% limb onset, 27% bulbar onset) with early ALS over a 36-week treatment period. The primary endpoint was the percent change in the summated motor unit index (MUNIX) scores to week 36.

The primary blinded comparative period was followed by an open-label extension (OLE) in which all participants received 30 mg of CNM-Au8 once-daily, with 90% (36/45 patients) entering the OLE. The primary endpoint was not significant, driven by limited MUNIX decline in bulbar-onset participants. However, in a prespecified analyses of limb-onset participants who demonstrated the expected decline in MUNIX scores, there was a strong trend for reducing MUNIX scores (p=0.074). There was a significant reduction in ALS disease progression evident in CNM-Au8 treated participants at week 36 (p=0.0125), and the risk of experiencing significant (≥ 6-point) decline in ALSFRSR was significantly reduced in the CNM-Au8 treated patients (p=0.035). Furthermore, CNMAu8 treated participants demonstrated improved quality of life on the ALSSQOL-SF (p=0.018). Importantly, there were no significant CNM-Au8 related adverse effects reported.

About CNM-Au8 ®
CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to protect neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 ® is a federally registered trademark of Clene Nanomedicine, Inc.

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. 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 or follow us on Twitter , LinkedIn and Facebook.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Media Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310
Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
617-283-2856

Source: Clene Inc.


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  • No approved MS DMTs have shown global neurological improvement in stable MS patients, a significant unmet medical need in MS
  • CNM-Au8 treatment was well-tolerated, and no significant safety findings were observed

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that the VISIONARY-MS trial results were featured as a platform presentation by Professor Michael Barnett, MBBS FRACP PhD at the 14th Annual Singapore Pan-Asian Committee on Treatment and Research in Multiple Sclerosis (PACTRIMS) Congress held November 24-26.

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  • Secondary survival endpoint for the   CNM-Au8 ®   30 mg dose investigated in the Healey ALS Platform Trial demonstrated a >90% reduction in the risk of death or death equivalent (permanently assisted ventilation) and risk of death alone at 24 weeks . This survival benefit was consistent with prior results reported from the Phase 2 RESCUE-ALS trial long term open-label extension.
  • Topline results from the Phase 2 VISIONARY-MS clinical trial of   CNM-Au8 ® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and global neurological improvement measured by the modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the modified intent to treat (mITT) population   .
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  • Executed a Commitment Letter with the Maryland Department of Housing and Community Development to borrow $5.0 million.

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"Clene was pleased to report the significant survival benefit in people living with ALS in the Healey ALS Platform Trial at six months with the CNM-Au8 ® 30 mg dose. To our knowledge, this is the only study to show a survival benefit at 6-months in ALS," said Rob Etherington, President and CEO of Clene. "Subsequent to the Healey data read-out, we have been able to secure sufficient capital to further strengthen our balance sheet, extend our financial runway, and support the regulatory path to potential marketing authorization. We remain in active discussions with potential strategic partners regarding CNM-Au8. We are also looking forward to the further results from the full Healey data set, including biomarker data and exploratory endpoints, during the coming months."

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AbbVie Biotech Innovators Award. (CNW Group/AbbVie Canada)

"We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda , CEO & Co-Founder of Neuropeutics Inc.

Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease.

"It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients."

"Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon , Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup."

The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work or wet lab incubator at the University of Toronto . The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto . Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives.

For more information on the AbbVie Biotech Innovators Award, please visit: https://spinup.utm.utoronto.ca/biotech-innovators-award/ .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Instagram or find us on LinkedIn .

About SpinUp
SpinUp is the first wet lab startup incubator at the University of Toronto , Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity . SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at spinup.utm.utoronto.ca and connect with us on Instagram and LinkedIn .

SpinUp is proudly part of U of T Entrepreneurship , a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT . The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership.

About Neuropeutics Inc  
Neuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at www.neuropeutics.ca , contact us at info@neuropeutics.ca , and connect with us on LinkedIn .

Neuropeutics Inc CSO & co-founder Dr. Janice Robertson (left) and Dr. Marc Shenouda, CEO & Co-Founder. (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2025/22/c0315.html

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