Cenna Biosciences Inc., a biopharmaceutical company focused on Alzheimer's disease (AD) treatments, has been awarded a $2.7 million Phase II SBIR grant from the National Institutes of Health (NIH), National Institute on Aging (NIA), to support the early clinical development of Nubytide™, a peptide drug for AD prevention and treatment. The grant will facilitate IND-enabling studies and Phase 1 clinical trials, with an IND filing planned for early 2025.
Addressing Alzheimer's with Novel Peptide Therapy
Alzheimer's disease affects 55 million people worldwide, including 6 million in the U.S., and its prevalence is expected to increase by 2.5% annually in major pharmaceutical markets. Current treatments are limited, creating an urgent need for new medications that can prevent onset, delay progression, or improve symptoms. Cenna Biosciences is developing Nubytide™ as a first-in-class, disease-modifying drug designed to arrest the underlying cause of AD.
Nubytide™: A Potential Advance Over Antibody Therapies
Nubytide™, a small peptide administered via subcutaneous injection, targets the production of toxic amyloid-beta (Aβ) species, differing from monoclonal antibody (MAb) drugs that remove Aβ after deposition in the brain. Cenna anticipates that Nubytide™ will be safer than MAb drugs, which can cause ARIAS (bleeding and swelling in the brain), as peptides are not expected to produce such adverse effects.
Clinical and Commercial Implications
According to Cenna Biosciences, an effective disease-modifying drug that slows or prevents AD progression would offer significant commercial and societal benefits, improving the quality of life for an aging population. Funding for Nubytide™'s development has totaled over $21 million through NIH and other non-dilutive grants. The company plans to seek additional investment through strategic partnerships and equity investors to accelerate development.
Leadership Perspective
"Cenna is thrilled to receive this grant award to move this important work forward, to prepare an IND package for submission to the U.S. FDA, and undertake our Phase 1 clinical trials," said Nazneen Dewji, Ph.D., Principal Investigator on the grant, President and Chief Executive Officer and Chairman of the Board of Directors of Cenna. David H. Crean, Ph.D., Board member of Cenna Biosciences, added, "This NIH grant is a significant milestone for Cenna Biosciences and a strong validation of the potential of the Company's technology."
