Full Press Release Details
Update on AdCOVIDTM Phase 1 Clinical Trial
AdCOVID was well tolerated but did not stimulate an adequate immune response in healthy volunteers
Altimmune will discontinue further development of AdCOVID and focus its resources on its ongoing obesity and liver programs
Altimmune also provides an update on its T-COVIDTM Phase 1/2 Clinical Trial
GAITHERSBURG, MD - June 29, 2021
-- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational
vaccine for the prevention of COVID-19. The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential
of T-COVID to prevent clinical worsening in patients with early COVID-19.
The Phase 1 AdCOVID clinical trial is evaluating
the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between
the ages of 18 and 55. Subjects received either 1 or 2 doses of AdCOVID as a nasal spray at 3 dose levels. In addition to the primary
study endpoint of safety and tolerability, the immunogenicity evaluation of AdCOVID included serum binding and neutralizing antibody titers
and mucosal IgA antibody from nasopharyngeal swabs post-vaccination.
AdCOVID appeared to be well tolerated with an
overall adverse event profile similar to intranasal saline placebo. The immunogenicity data demonstrated lower than expected immune responses
for each of the immune parameters tested. Although antibodies were detected that bound the SARS-CoV-2 Spike protein and neutralized the
virus in a subset of subjects, the magnitude of the response and the percent of subjects responding to AdCOVID were substantially lower
than what had been demonstrated for other vaccines already authorized for emergency use. Based on these data, and in view of the highly
competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase
"The immune response to AdCOVID was inferior
to that seen in our NasoVAX influenza vaccine trial," commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune. "Unlike
the NasoVAX study, the AdCOVID study population lacked immunity from prior infection or vaccination. We believe that prior immunity in
humans may be important for a robust immune response to intranasal dosing with AdCOVID."
"The top-line Phase 1 clinical data are
disappointing given the encouraging preclinical data and our substantial efforts in advancing a differentiated, intranasal vaccine candidate
in the fight against COVID-19," said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "However, we
are fortunate to have a strong pipeline with highly differentiated product candidates targeting indications of significant unmet need.
Moving forward, Altimmune will focus its resources on the development of ALT-801 and HepTcell, its novel peptide-based therapeutics for
obesity and liver diseases.
Dr. Garg continued, "Encouraging 6-week
interim data were recently demonstrated in our ongoing ALT-801 12-week Phase 1 clinical trial in overweight and obese volunteers, demonstrating
significant weight loss without the need for dose titration and only transient nausea with no reports of vomiting, diarrhea or constipation.
With our strong balance sheet providing a cash runway into 2023, we look forward to advancing our obesity and liver disease programs in
the second half of 2021 and beyond."
The Phase 1/2 trial completed dosing in 2 of the
3 planned dose cohorts. The first 2 cohorts were designed to assess the safety of T-COVID treatment and were comprised of COVID-19 infected
patients 49 years or younger with a low risk of progression to serious disease. In these cohorts, T-COVID was well tolerated without any
serious adverse events observed. The 3rd cohort was intended to evaluate the efficacy of treatment and enroll patients over
the age of 65 or with increased risk of serious sequelae by virtue of pre-existing comorbidities. However, the effective rollout in the
United States of authorized COVID-19 vaccines and decreasing incidence of disease significantly reduced the number of patients meeting
these criteria, and Altimmune has been unable to enroll subjects in the final cohort.
As a result of these enrollment challenges, the
Company has decided to terminate further enrollment and evaluate options for future T-COVID development following an assessment of the
available data and discussions with its partners, the U.S. Army Medical Research & Development Command (USAMRDC) and the Medical Technology
Enterprise Consortium (MTEC).
is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver disease and intranasal vaccines.
Our pipeline includes next generation peptide therapeutics for obesity, NASH (ALT-801), and chronic hepatitis B (HepTcell ); proprietary
intranasal vaccines; and an immune modulating therapeutic for COVID-19 (T-COVID ). For more information on Altimmune, please visit
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Forward-Looking Statement
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 data readouts from ALT-801 clinical trials in the second half
of 2021 and beyond, sufficient cash on hand to fund the Company into 2023, the prospects for regulatory approval, our ability to manufacture
material for our clinical trials and commercial needs, and commercializing or selling any product or drug candidates, including ALT-801
and HepTcell, 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 Altimmune, Inc. (the "Company") may identify forward-looking
statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties,
which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward
looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the
COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment,
adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human
safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability
to obtain potential regulatory approvals on the timelines anticipated; the success of future product advancements, including the success
of future clinical trials; and funding delays, reductions in or elimination of U.S. government
funding with USAMRDC. Further information on the factors and risks that could affect the Company's business, financial conditions
and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including
under the heading "Risk Factors" in the Company's annual report on Form 10-K for the fiscal year ended December
31, 2020 filed with the SEC, which is available at www.sec.gov.
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