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Details:
Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints.
Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: M-001
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate and severity, as well as to assess M-001's safety.
Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: M-001
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA.
Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
BiondVax's pivotal, Phase 3 trial in Europe is ongoing. The trial, which is assessing M‑001's ability to provide clinical protection from any circulating influenza strain, is being conducted with volunteers aged 50+ (with half aged 65+) over two flu seasons in 7 countries.
Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $4.2 million Upfront Cash: Undisclosed
Deal Type: Funding May 20, 2020
Details:
The data, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.
Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2020
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