Altimmune Announces its Phase 2 Flu Vaccine Trial with NasoVAX Open for Enrollment
- Category: Vaccines
- Published on Thursday, 21 September 2017 09:31
- Hits: 630
60 Patients to be enrolled
Data expected in the first quarter of 2018
GAITHERSBURG, MD, USA I September 20, 2017 I Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced that they have been cleared by the FDA to initiate their Phase 2 clinical study of NasoVAX, the Company’s intranasally administered recombinant flu vaccine. NasoVAX is a new type of influenza vaccine that uses intranasal administration to potentially stimulate a broader and more rapid immune response than currently approved flu vaccines.
“This trial is designed to confirm the differentiating factors, such as immune response to both matched and divergent strains, that were observed in our preclinical studies,” said Dr. Sybil Tasker, Chief Medical Officer at Altimmune. “We are actively recruiting patients in our trial and this represents an exciting step forward in our development of NasoVAX.”
The Phase 2 NasoVAX study is a proof-of-concept study that will assess the safety and immunogenicity of a single intranasal dose at three dose levels. The Company will evaluate the breadth of the immune response to both matched and divergent strains, along with mucosal and cellular immune responses. The study is expected enroll 60 healthy adults, between the ages of 18 and 49, who will receive a single intranasal dose of vaccine or placebo. For more information about the trial, please see https://clinicaltrials.gov/ct2/show/NCT03232567. The Company continues to expect to report the results of the trial in the first quarter of 2018.
NasoVAX differs from traditional influenza vaccines in the way it stimulates the immune system. By presenting the influenza protein intracellularly, additional immune mechanisms are activated, potentially leading to more rapid and robust protection. Preclinical studies with NasoVAX have demonstrated broad protection against matched and mis-matched influenza strains, with protection occurring in as little as two days post-vaccination. NasoVAX is manufactured using a cell-based strategy that promises to be faster and more controlled than current egg-based vaccine production.
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines.