Life Science News

  • As of the July 5, 2022, data cutoff, early CNM-Au8 ® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)
  • CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during this open-label trial
  • Top-line results from HEALEY ALS Platform Trial are expected in current quarter

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 disease, today reported significantly improved survival in ALS patients initially treated with CNM-Au8 compared to initially randomized placebo treated participants during the long-term open-label extension of its RESCUE-ALS trial.

"We are very pleased to see these results and the apparent survival benefit that our investigational drug, CNM-Au8, appears to provide to people living with ALS," said Rob Etherington, President and CEO of Clene. "At this point, we are awaiting top-line data from the HEALEY ALS Platform Trial, which focuses on endpoints measuring patient function, survival and breathing over a six-month period in a much larger cohort. Clene expects to announce these results this quarter. Based on the larger number of patients treated in the HEALEY trial and the higher dose of CNM-Au8 being tested, we are optimistic that we will be able to adequately characterize the effects of our drug on this devastating disease."

Study participants in RESCUE-ALS were randomized 1:1 to receive 30 mg of CNM-Au8 or placebo daily for 36 weeks during the double-blind portion of the study, followed by an open-label period that extended treatment up to 130 weeks from randomization. The trial enrolled 45 participants (n=23 on active treatment, and n=22 receiving placebo), and survival was compared by treatment group from randomization through the latest vital status observation with a cut-off as of July 5, 2022, for this interim analysis. Participants in the placebo-treated group, who received either no treatment or a nine-month delay in treatment initiation with CNM-Au8, were compared to participants treated daily with CNM-Au8 from randomization.

Survival data were obtained for 43 of 45 study participants, and one participant in each group was lost to follow-up. There were five deaths in the group originally randomized to CNM-Au8 and 14 deaths in the group originally randomized to receive placebo. Median survival from randomization for the CNM-Au8 group was undefined due to insufficient mortality events, and median survival for the placebo group was 23.1 months. Unadjusted Kaplan-Meier survival analyses demonstrated a significant survival benefit with participants initially randomized to CNM-Au8 treatment versus those initially randomized to placebo, resulting in a 70% decreased risk of death, log-rank hazard ratio = 0.301 (95% CI: 0.122 to 0.742, p = 0.0143). Sensitivity analyses substituting death in place of lost to follow-up censoring resulted in concordant findings (Hazard Ratio: 0.338, 95% CI: 0.143 to 0.797, p = 0.0182). The treatment was well-tolerated, and there were no significant safety findings reported during the long-term open label trial period. These data will be reported at an upcoming scientific congress.

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 .

About CNM-Au8 ®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore 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.

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 Investor Contact
Erica Fiorini, Ph.D., or David Schull Kevin Gardner
Russo Partners, LLC LifeSci Advisors
Erica.fiorini@russopartnersllc.com kgardner@lifesciadvisors.com
David.schull@russopartnersllc.com 617-283-2856
212-845-4253

Source: Clene Inc.


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Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

  • Topline results from the Phase 2 VISIONARY-MS clinical trial with CNM- Au8 ® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population
  • Updated data from RESCUE-ALS demonstrate a statistically significant decrease in mortality in participants who entered open-label extension study ( 5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)
  • Topline results from HEALEY ALS Platform Trial expected this quarter
  • Cash, cash equivalents and marketable securities of $26.3 million as of June 30, 2022
  • Entered into a $3.0 million loan facility from State of Maryland to support development of commercial manufacturing facility

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 disease, today reported its second quarter 2022 and recent operating highlights.

"We are on the cusp of a transformative period for the Company as we await a key data readout in ALS for our lead asset, CNM-Au8 ® ," said Rob Etherington, President and CEO of Clene. "The ALS patient population is desperate for new treatments to help mitigate the disease course and following the statistically significant survival benefits demonstrated in our open label trial, we are hopeful that we can deliver an effective therapy for people living with ALS."

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Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

  • CNM-Au8 met primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population

  • Consistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers, providing physiological evidence for its potential neuroprotective and remyelinating effects

  • CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

  • Results provide support to advance CNM-Au8 into Phase 3 clinical development

  • Clene to host a call and webcast at 7:30 am EDT today

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 positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8 ® an investigational gold nanocrystal suspension, in participants with stable relapsing remitting multiple sclerosis (RRMS).

VISIONARY-MS was a Phase 2 proof-of-concept, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) as adjunctive therapy to currently available disease-modifying therapies (DMTs) versus placebo over 48 weeks in stable RRMS participants with chronic optic neuropathy.

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Clene to Host VISIONARY-MS Results Call and Webcast on August 15

Clene to Host VISIONARY-MS Results Call and Webcast on August 15

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 disease, today announced that it will present results from its Phase 2 VISIONARY-MS trial at 7:30 a.m. EDT on Monday, August 15.

Conference Call and Webcast Details:
Presentation Time: 7:30 a.m. EDT on August 15, 2022
Investors (Toll free): 1 (888) 770-7152
Conference ID: 5318408
Webcast link

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Clene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8® for the Treatment of ALS

Clene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8® for the Treatment of ALS

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 disease, today reported that it has received a positive opinion for its submission requesting Orphan Drug Designation for CNM-Au8® for the treatment of amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

Orphan Drug Designation in Europe is granted for a serious or life-threatening disease affecting not more than five in 10,000 people. Clene would benefit from this designation with protocol assistance, reduced regulatory fees and market exclusivity. The positive opinion for Orphan Drug Designation for CNM-Au8 in ALS was based on data submitted from the Phase 2 RESCUE-ALS trial and preclinical ALS models.

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Cybin and Clinilabs Granted Schedule I DEA License for CYB003 Phase 1/2a First-In-Human Clinical Trial

Cybin and Clinilabs Granted Schedule I DEA License for CYB003 Phase 1/2a First-In-Human Clinical Trial

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics™", and its partner Clinilabs Drug Development Corporation ("Clinilabs"), a global, full-service contract research organization with deep expertise in central nervous system drug development, today announced that the U.S. Drug Enforcement Agency ("DEA") has granted a Schedule I license to support the first-in-human Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog that is being developed for the treatment of major depressive disorder ("MDD").

"Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003. Our rigorous recruitment and enrollment process is well under way, and we are excited to commence dosing of our first cohort of participants," said Doug Drysdale, Chief Executive Officer of Cybin.

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Ambrx Biopharma Appoints Kate Hermans as Interim CEO, Replacing Feng Tian

Ambrx Biopharma Appoints Kate Hermans as Interim CEO, Replacing Feng Tian

- Katrin Rupalla, Ph.D., appointed Chair of Ambrx's Board of Directors -

- Ambrx to conduct strategic pipeline review with focus on commercial opportunity and cash runway extension -

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Cybin Announces Results of Shareholders' Meeting

Cybin Announces Results of Shareholders' Meeting

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM ", is pleased to announce the voting results for each of the matters presented at the Company's annual meeting of shareholders held on August 15, 2022 (the " Meeting "). There were 71 shareholders represented in person or by proxy at the Meeting holding 47,019,721 common shares, representing 28.3% of Cybin's total issued and outstanding common shares as at the record date for the Meeting. The voting results for each matter presented at the Meeting is set out below:

1. Appointment of Auditor

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Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

$145 million of Total revenue in Q2 2022, representing 231% growth over Q2 2021

13 new Cell Programs added in Q2 2022, representing 86% growth over Q2 2021

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Ginkgo Bioworks and XpresCheck Receive Award to Expand CDC's Traveler-Based SARS-CoV-2 Genomic Surveillance Program In U.S. Airports

Ginkgo Bioworks and XpresCheck Receive Award to Expand CDC's Traveler-Based SARS-CoV-2 Genomic Surveillance Program In U.S. Airports

Ginkgo Bioworks (NYSE: DNA ) and XpresSpa Group, Inc. (Nasdaq: XSPA) announced they will continue to support the Centers for Disease Control and Prevention's (CDC's) traveler-based SARS-CoV-2 genomic surveillance program through a new contract awarded August 12, 2022. The partnership is expected to support public health and biosecurity services totaling approximately $16 million, with an overall potential to exceed $61 million based on CDC program options and public health priorities. As COVID-19 sublineages and other biological threats continue to emerge, the partners plan to expand the program footprint and incorporate innovative modalities and offerings, such as monitoring of wastewater from aircraft lavatories.

Concentric by Ginkgo, the biosecurity and public health initiative of Ginkgo Bioworks, XpresCheck by XpresSpa Group, a leading provider of COVID-19 surveillance and diagnostic testing in U.S. airports, and CDC have partnered since August 2021 to deliver timely public health data on SARS-CoV-2 variants and their sublineages, including the first U.S. detections of Omicron BA.2 and BA.3 . The expanded program will serve as an early warning system to detect new or emerging SARS-CoV-2 variants, and can facilitate response to future travel-associated outbreaks and pandemics. It provides a pulse of COVID-19 cases and the arrival of variants among international travelers, delivering important data as the country monitors the global COVID-19 situation.

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GreenLight Biosciences Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress

GreenLight Biosciences Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress

GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person in our planet, today reported operational highlights and financial results for the second quarter ended June 30, 2022.

"GreenLight's RNA platform has continued to prove its value for developing a wide range of solutions to feeding the world and keeping it healthy. We founded GreenLight to change the world, and we have continued to make progress this quarter," said Andrey Zarur, CEO of GreenLight. "Today, we are pleased to announce a capital infusion of $108.4 million. We are grateful for the support, continued faith, and trust of our longtime investors. We also welcome new investors who have decided to join GreenLight in our mission to help feed the world and keep it healthy. This will allow us to continue to make progress across our pipeline.

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