Clearance advances 8M2D, designed to inhibit β-amyloid production rather than clear plaque after it forms; first participant expected to be dosed in late 2026
LA JOLLA, CA / ACCESS Newswire / June 17, 2026 / The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of Cenna Biosciences (Cenna) to begin a Phase 1a/1b clinical trial of 8M2D, a first-in-class peptide for the treatment of Alzheimer’s disease (AD). 8M2D is designed to address the root cause of AD by inhibiting the production of β-amyloid (Aβ), rather than clearing it after it has already accumulated in the brain. “FDA clearance of our IND is a defining milestone for Cenna,” said Nazneen Dewji, Ph.D., Chief Executive Officer of Cenna. “The amyloid-targeting therapies approved to date all work by clearing plaque after it has formed. 8M2D is designed to intervene earlier in the disease process, by stopping amyloid from being produced. This clearance allows us to test that approach in people, and we expect to dose our first participant in late 2026.”
About 8M2D
8M2D is a first-in-class peptide that offers a differentiated approach to treating AD by targeting the disease at its origin: the production of Aβ. Aβ is a central driver of disease progression, a target recently validated by the FDA approval of three anti-amyloid monoclonal antibodies (mAbs). Unlike those antibodies, which remove Aβ after it has been deposited, 8M2D is designed to inhibit the production of Aβ, an earlier point of intervention. It blocks the processing of the amyloid precursor protein (APP) to Aβ without targeting, inhibiting, or modulating β- or gamma-secretase activity, an approach intended to avoid the toxicities that undermined earlier secretase inhibitors. Because 8M2D is a peptide and does not act through the antibody-mediated mechanism associated with amyloid-related imaging abnormalities (ARIA), it is not expected to carry the ARIA risk seen with approved mAb therapies. 8M2D is designed for subcutaneous administration.
Clinical Trial Design
The Phase 1a/1b program comprises two stages. The Phase 1a stage is a two-part (single ascending dose [SAD] and multiple ascending dose [MAD]), randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and exploratory immunogenicity of single and multiple doses of 8M2D in healthy participants. The Phase 1b stage is an open-label trial evaluating multiple doses of 8M2D in participants with early AD. The primary endpoint is the safety and tolerability of 8M2D. Secondary endpoints will assess the effect of 8M2D on Aβ production, including changes in cerebrospinal fluid (CSF) and plasma biomarkers of Aβ, tau, phosphorylated tau (p-tau), and inflammation.
About Alzheimer’s disease
Alzheimer’s disease (AD) is a progressive, irreversible brain disorder that gradually destroys memory and thinking. It is the most common cause of dementia. About one in nine Americans age 65 and older is living with Alzheimer’s, rising to roughly one in three among those age 85 and older. An estimated 7.4 million Americans age 65 and older and more than 55 million people worldwide are living with the disease, and therapeutic options remain limited.
About Cenna
Cenna Biosciences is a private, clinical-stage biopharmaceutical company based in La Jolla, California, focused on discovering and developing novel therapies for Alzheimer’s disease. Cenna is advancing 8M2D, a first-in-class peptide, into Phase 1 clinical development. The company has been funded almost entirely through non-dilutive NIH and other grants and is currently raising capital to support its planned Phase 1a/1b program.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of applicable securities laws. Statements in this press release that are not purely historical are forward-looking statements, including those regarding the therapeutic potential of 8M2D, plans for upcoming clinical trials, regulatory timelines, and the Company’s future development strategies. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s current expectations and assumptions, which are inherently subject to risks, uncertainties, and changes in circumstances. Actual results may differ materially from those indicated by these forward-looking statements due to numerous factors, including but not limited to: The timing and success of clinical trials and related research; Unforeseen safety, regulatory, or clinical complications; The Company’s ability to raise sufficient capital to fund its planned operations; and Market conditions and competitive developments
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company disclaims any obligation to publicly update or revise any forward-looking statements to reflect new information, future events, or otherwise, except as required by law.
Media and Investor Contact
Dr. Nazneen Dewji
Cenna Biosciences, Inc.
Email: ndewji@cennabiosciences.com
Phone: 858-336-6749
https://www.cennabiosciences.com
SOURCE: Cenna Biosciences Inc.
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