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®), 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.
About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, specifically chronic, debilitating diarrhea. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.
Mytesi® (crofelemer delayed release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that additional content will be added to the Napo EU website soon, the belief that GI symptoms in long-hauler COVID patients may also 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, and the belief that crofelemer's mechanism of action has the potential to benefit multiple disorders. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Source: Jaguar Health, Inc.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.