Cenna Biosciences Receives FDA Clearance to Begin Phase 1a/1b Clinical Trial of 8M2D, a First-in-Class Peptide Designed to Stop the Production of Amyloid in Alzheimer’s Disease

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

Excerpt from the Press Release:

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.

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