Jaguar Health Exploring Possibility of Conditional Marketing Authorization for Proposed Inflammatory Diarrhea Indication for Crofelemer, Initially in ‘Long-Hauler’ COVID-19 Recovery Patients in Europe
New COVID-19 strain estimated to have tripled number of infections in
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The head of emergencies at the
"The virus is moving with urgency, and so are we at
The potential COVID-related indication for crofelemer is the subject of the proposed exclusive license from Napo to Napo EU, a subsidiary being established by the Company in
"The Company participated in a ‘test the waters' road show in December which contemplated a proposed
"Our intention is to focus clinical exploration for the proposed COVID-related indication for crofelemer in
"The timeline for potential approval will be discussed with the EMA in accordance with the conditional marketing authorization process," Conte added. To learn more about this process, click here.
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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.
Endpoints being explored in
Napo has conducted intellectual property filings in support of the development of crofelemer for the potential indication of addressing inflammatory diarrhea, including specifically in a long-hauler post-COVID recovery situation. As with all potential follow-on indications, Napo prioritizes IP protection. Napo currently holds approximately 144 patents, the majority of which do not expire until 2027 - 2031, and approximately 39 patents pending.
Mytesi (crofelemer delayed release tablets), the only oral plant-based prescription medicine approved under
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 Company's plans to explore the possibility of obtaining conditional marketing authorization in
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