Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December
Simple, single-dose nasal spray offers greater ease and comfort of administration;
positioning AdCOVID as a differentiated vaccine candidate for adults and children
AdCOVID is capable of stimulating an additional and specialized type of immunity – local nasal mucosal immunity – believed to be critical for preventing
further transmission of the virus
“We’ve made exceptional progress advancing AdCOVID and are on track to begin a Phase 1 clinical study this year, with a data readout anticipated in the first quarter of 2021,” said
“It’s not widely known or appreciated that nasal mucosal immunity may be essential in preventing the spread of the SARS-CoV-2 virus to other individuals by stopping replication and transmission of the virus at the site of infection – the nose and respiratory tract,” said
In a recent pre-IND meeting, the FDA agreed to the overall Phase 1 study design and patient population, as well as plans for manufacturing and product testing of AdCOVID. The FDA also confirmed that additional nonclinical studies were not required and that the toxicology data previously submitted and reviewed for Altimmune’s NasoShield™ and NasoVAX™ intranasal vaccine candidates support the clinical development of AdCOVID, with no additional toxicology studies required before initiation of the Phase 1 trial.
In recently published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the
Based on data from Altimmune’s other intranasal platform vaccines (NasoVAX™ and NasoShield™) AdCOVID is expected to have extended stability at room temperature allowing for cold chain-free shipment of the vaccine, where it can then be stored in common refrigerators found in community-based doctor’s offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the number of people willing to take the vaccine.
Altimmune anticipates commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020 with a data readout in the first quarter of 2021.
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the AdCOVID Phase 1 clinical trial in Q4 2020 and data readout in Q1 2021, the potential immunization effects of AdCOVID, the shipping and storage requirements for AdCOVID, the willingness of the general public to use AdCOVID, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to
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Source: Altimmune, Inc.