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Cenna Biosciences Inc., a privately-held biopharmaceutical company based in La Jolla, California, and focused on developing novel treatments for Alzheimer’s disease (AD), has been awarded a Phase II SBIR grant of $2.7M from the National Institutes of Health (NIH), National Institute on Aging (NIA), to support the early clinical development of their peptide drug NubytideTM, for the prevention and treatment of AD. AD is a complex disorder for which there are few treatments. There are 55 million people living with AD worldwide, and 6 million in the U.S. alone. The prevalence of AD is expected to grow at a rate of 2.5% per year in the seven major pharmaceutical markets of the world. New medications to prevent the onset, delay progression, or improve symptoms of AD are urgently needed.
Cenna Biosciences is focused on the development of a first-in-class disease-modifying drug for the prevention and treatment of AD using a transformational, proprietary patented technology that arrests the underlying cause of the disease and addresses previous failures by others. Cenna’s drug is a small peptide that has many advantages over the recent FDA-approved monoclonal antibody (MAb) drugs for AD. NubytideTM can be administered more easily by subcutaneous injection, is believed to be less expensive to produce and is the earliest intervention, stopping the very production of the primary toxic species Aß, as opposed to removing Aß after its deposition in the brain. It is anticipated to be safer than MAb drugs, which are known to produce ARIAS (bleeding and swelling in the brain), as peptides are not expected to produce ARIAS. IND-enabling pre-clinical studies are completed, and an IND filing is planned in early 2025. It is anticipated that Cenna’s peptide therapeutic will have a significant impact in both treatment and prevention modes and be useful throughout the course of disease. An effective disease-modifying drug that slows progression or prevents AD will have significant commercial and societal benefits related to the quality of life for an aging population. Funding to date has been through NIH and other non-dilutive grants totaling more than $21million and by the founders. The Company will be seeking additional investment in the coming months through strategic partnerships and equity investors to accelerate development.
Nazneen Dewji, Ph.D., Principal Investigator on the grant, President and Chief Executive Officer and Chairman of the Board of Directors of Cenna, said, “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. The funding will help us raise additional investment towards future clinical studies which will be required to advance our product towards approval and help patients afflicted with this disease. We are very grateful to the NIH for their continued support of our studies and our novel approach.” 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. The innovative approach targeting the underlying cause of Alzheimer’s disease positions Cenna at the forefront of developing next-generation therapeutics for this devastating condition. We’re excited about the prospects of moving into clinical trials and the potential impact this could have on millions of patients worldwide.”
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