- First patient, first visit is planned for early
June 2024 - Enrollment has been expanded by 80% to a maximum of 180 participants
- ‘Real-world’ drug efficacy data will be collected by monitoring potential drug effects on survival and disease progression, as well as safety
Late last year, in collaboration with
ALS is a deadly neurodegenerative disease with no known cure. In recognizing the need for accessibility and inclusion in such programs for individuals with ALS,
“The Clene team recognized that there was great need in the ALS community for more access to promising treatments,”
In addition to meeting the requisite safety standards set by the FDA for all EAPs, Clene’s ACT-EAP was designed to contribute research results to the public understanding of ALS disease progression and response to therapy. To this end, the clinical teams at
- To add ‘real-world’ drug exposure data to the growing clinical safety database on CNM-Au8
- To assess ‘real-world’ drug efficacy data by monitoring potential drug effects on survival and disease progression with the use of natural history and control clinical trial database comparators. Biomarker data will also be collected and analyzed in parallel.
“CNM-Au8 treatment has been associated with lowered risk of death and delayed clinical worsening – all while being very well-tolerated, in both of our independent Phase 2 clinical studies,” added
“It’s important to note that this is not just a standard EAP, in which we provide investigational product to individuals with ALS through an FDA-regulated program,” explained Dr. Jinsy A. Andrews, MD, MSc, FAAN, of
“We are pleased to be the first-ever fully virtual clinical site to participate in an EAP - or any clinical study for that matter,” said
The first patient first visit for the ACT-EAP is planned for
This study is supported by
About Expanded Access Programs
An EAP is also referred to as Compassionate Use and is an FDA-regulated pathway that allows people with a serious and life-threatening disease to access an investigational drug that is not yet approved by the
About
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@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310
Investor Contact
kgardner@lifesciadvisors.com
(617) 283-2856
![](https://ml.globenewswire.com/media/MmY3YTY0MzUtYzIzOC00NTE0LTlhZWMtNWRhN2JhMTliZmMyLTEyNTc5OTk=/tiny/Clene-Inc-.png)
2024 GlobeNewswire, Inc., source