NEW YORK—Hoth Therapeutics, Inc. has entered into a non-exclusive commercial evaluation license agreement with the US Army Medical Research and Development Command (USAMRDC). The agreement covers a new molecular entity developed by the Walter Reed Army Institute of Research with a novel antibacterial mechanism of action that targets multiple bacterial pathogens.
While this molecular entity (to be developed as HT-006) has the potential to treat many different types of bacterial infections, Hoth initially plans to target bacterial infections of the lung, like hospital-acquired pneumonia and ventilator-associated pneumonia. Both are considered life-threatening diseases for which current treatment options are limited or ineffective against multi-drug resistant bacteria.
Licensing through the USAMRDC will provide Hoth with the opportunity to collaborate with U.S. Army laboratory resources and research personnel during development of HT-006 — including the Walter Reed Army Institute of Research and the U.S. Army Aeromedical Research Laboratory, as well as USAMRDC experts. Hoth plans to begin preclinical studies for HT-006, investigating the minimal inhibitory concentration for various multi-drug resistant bacterial species, in the first quarter of 2021.
Hoth also says that the company intends to pursue streamlined development opportunities under the FDA’s “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases” program, as it allows for the use of nonclinical animal studies to reduce the number of clinical studies required for approval.
“Hoth is proud to be partnering with the U.S. Army Medical Research and Development Command on such an extensive and innovative endeavor,” said Dr. Stefanie Johns, chief scientific officer of Hoth Therapeutics. “We are excited about the potential impact that novel antibiotic treatments with HT-006 can have on the millions of patients that are afflicted with pneumonia.”
In other news from the company, Hoth Therapeutics also recently reported a sponsored research agreement with the George Washington University (GW) for the development of an in vitro diagnostic device for SARS-CoV-2 that could test patients anywhere. The device will reportedly allow public health professionals to immediately detect SARS-CoV-2 with a mobile device.
“A device that can provide immediate COVID-19 test results would have a dramatic impact on our economy returning to normal once again. We are committed to doing what we can to fast-track the development of this device, which could potentially have a monumental impact in slowing and or stopping the spread of COVID-19 when its presence is detected,” added Robb Knie, chairman and CEO of Hoth Therapeutics, in a press release.
The diagnostic, based on intellectual property rights licensed by Hoth from GW, is a nanohole array (NHA)-based plasmonic system that uses a thin sheet of gold coated with virus-specific proteins that can bind with the SARS-CoV-2 virus. Once the virus binds, the wavelength of light bouncing off the surface changes — creating a different color of light. This change in color could be detected by a smartphone camera and an app with algorithms designed to detect SARS-CoV-2. This type of test has the potential to provide results within minutes, and the results could then be sent to healthcare professionals or public health databases using an app on a patient’s mobile device.
“Our research team is very pleased that Hoth Therapeutics has decided to partner with GW to develop this important SARS-CoV-2 virus detection system. Our device has great potential to help in the fight against COVID-19, and we are proud to be able to contribute to stopping the spread of the disease,” commented Dr. Mona Zaghloul, professor of electrical and computer engineering at GW and the principal investigator of the research team which created the diagnostic.
The objective of the agreement is to design and assess the analytical performance of the NHA-based system to directly detect the SARS-CoV-2 virus, and to distinguish that binding from other human coronaviruses.
As of November, Hoth Therapeutics noted that proof-of-concept research data supporting sensitive detection of SARS-CoV-2 virus by prototype devices was expected by the end of 2020, with further studies characterizing specificity of the device planned for 2021.
“There is a significant unmet need for rapid COVID-19 in vitro diagnostic devices that can be used at home or in other non-lab settings by patients,” Johns pointed out. “We plan to start discussions with the US Food and Drug Administration about the development plans for this novel technology in early 2021 to position the device for an emergency use authorization request.”