Rare disease therapy—Cenna’s 8M2D gets IND clearance for Alzheimer’s peptide program

Cenna Biosciences has obtained IND clearance from the FDA for 8M2D, a first-in-class peptide candidate for the treatment of Alzheimer’s disease. The company said a Phase Ia/Ib trial in healthy volunteers and patients with early Alzheimer’s is expected to begin dosing late this year. 8M2D is designed as a peptide therapy aimed at addressing Alzheimer’s disease biology, with the program moving from preclinical to early human testing now that the FDA has cleared an investigational pathway. The clearance adds to the growing set of Alzheimer’s candidates entering early clinical evaluation, with investigators set to generate initial safety and tolerability data as well as early signals that could guide future development decisions.