Benzinga | Feb 23, 2021 08:36AM EST

Jaguar Health Highlights Launch Of Website For Napo EU

Site contains links to information about post-COVID-19 'long-hauler' syndrome

An article published yesterday in the San Francisco Chronicle references diarrhea as long-hauler symptom and the theory that the type of inflammation associated with HIV may also be present in long-hauler patients

Napo EU to explore conditional marketing authorization for proposed inflammatory diarrhea indication for crofelemer, initially in long-hauler COVID-19 recovery patients in Europe

SAN FRANCISCO, CA / ACCESSWIRE / February 23, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that the Company has launched the website for Napo EU, the anticipated subsidiary of the Company in Italy. Click here to visit the website.

The Resources page of the site contains links to an assortment of third-party information about post-COVID long-hauler syndrome, as well as the challenges posed in Europe and elsewhere by vaccine distribution programs, vaccine skepticism, and the appearance of more transmissible mutated strains of SARS-CoV-2, the virus that causes COVID-19.

"Long-hauler syndrome has been generating a great deal of coverage over the past several months in major media around the globe," stated Lisa Conte, Jaguar's founder, president, and CEO. "In fact, yesterday an article titled "Terrifying 'post-COVID syndrome' is next focus for researchers in Bay Area and beyond" was published by the San Francisco Chronicle. The article references diarrhea as a symptom of long-hauler syndrome, and the theory that the type of inflammation associated with HIV may also be present in long-hauler patients. We believe that GI symptoms in long-hauler patients may be related to inflammation, and thus analogous to GI symptoms observed in people who have lived with HIV/AIDS for a long period of time."

Gut inflammation referred to as enteropathy is a chronic syndrome that has been observed in people who live with HIV/AIDS for long periods of time and is manifested as chronic diarrhea. Crofelemer (Mytesi(r)), Napo's commercialized antidiarrheal drug, is FDA-approved in the U.S. for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

This past Friday, as also reported in the above-referenced the San Francisco Chronicle article, a University of Washington study published in the Journal of the American Medical Association found that 30% of 177 COVID patients reported symptoms up to 9 months after their illness. A link to the article appears on the Resources page of the Napo EU website. (Note that access to the article requires a subscription to the San Francisco Chronicle).

The Company plans to add additional content to the website soon.

As previously announced, the Company is exploring the conditional marketing authorization regulatory pathway in Europe to support development and commercialization of crofelemer for the proposed indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a long-hauler COVID-19 recovery patient population in Europe.

The terms long-hauler and "chronic COVID" refer to COVID-19 survivors who suffer with symptoms which may include gastrointestinal distress (i.e., diarrhea, constipation, nausea, pain), fatigue, brain fog, forgetfulness, cardiovascular effects, and arthritis, for an extended period after recovery. It is theorized that these symptoms may result when the immune system in COVID-19 survivors continues to overreact even though the infection has passed.

Mytesi (crofelemer delayed release tablets), the only oral plant-based prescription medicine approved under U.S. Food and Drug Administration (FDA) Botanical Guidance, is a novel, first-in-class anti-secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple disorders. Mytesi is a non-opiate chloride ion channel modulating antidiarrheal medicine that is approved in the U.S. by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.