On-The-Go Coronavirus Testing Device Prepares For Study
A biopharmaceutical company announced key upcoming milestones towards the commercial development of novel COVID-19 products currently being developed.
New York-based Hoth Therapeutics, Inc.’s products include HT-002 peptide therapeutic targeted to treat symptoms associated with COVID-19, the On-the-Go SARS-CoV-2 Testing Device, and VaxCelerate SARS-CoV-2 vaccine.
The On-the-Go SARS-CoV-2 Testing Device System is the first of its kind technology under development as a point-of-care / patient-use device as an aid in the diagnosis of COVID-19 infection.
The system uses a nanohole array-based plasmonic system that is being designed for high sensitivity and selectivity detection of the SARS-CoV-2 virus with rapid reporting of results.
The On-the-Go SARS-CoV-2 Testing Device is currently in the research phase of development. Proof-of-concept data supporting sensitive detection of the SARS-CoV-2 virus by prototype devices is expected by the end of 2020, with further studies characterizing the specificity of the device contemplated in 2021.
The initial research-level data is expected to be used to support a pre-Emergency Use Authorization (EUA) meeting with the US Food and Drug Administration (FDA) in 2021, which will be focused on the verification and validation requirements to obtain EUA for a non-laboratory use device.
And, the HT-002 is a novel peptide therapeutic targeted for the treatment of illness associated with SARS-CoV-2 infection.
The SARS-CoV-2 vaccine is being developed using VaxCelerate, a self-assembling vaccine platform licensed from the Vaccine and Immunotherapy Center at Massachusetts General Hospital by HaloVax, LLC. VaxCelerate offers two unique elements to combat SARS-CoV-2: a fixed immune adjuvant and variable immune targeting, the combination which is designed to elicit a robust, protective immune response.
SARS-CoV-2 live virus inhibition test data is expected to be available in December 2020, which would characterize the therapeutic potential of the HT-002 peptide in an in vitro model.
Pending results of the study, Hoth Therapeutics stated in a press release on November 2, 2020, it intends to pursue formulation development, preclinical safety testing, and meetings with the US FDA in 2021 for HT-002.
"COVID-19 disease remains a critical unmet medical need in the US and there still exists a significant gap for effective vaccines, safe and efficacious therapeutics, and rapid, accurate diagnostic tests that can be performed by patients at home. We are pushing an aggressive development timeline for each of the COVID-19 products to help fill this gap," stated, Stefanie Johns, Ph.D., Chief Scientific Officer of Hoth Therapeutics, in the release press release.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders.
CoronavirusToday publishes research-based news.