Jaguar Health Subsidiary Napo Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Crofelemer (Mytesi) for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
A Significant Proportion of Patients Receiving Targeted Cancer Therapy Experience Diarrhea
Initial Tranche of Non-dilutive Financing Transaction Increased from
The Phase 3 pivotal clinical trial is a 24-week (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer (Mytesi) in providing prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted cancer therapy-containing treatment regimens. Crofelemer or placebo treatment will start concurrently with the targeted cancer therapy regimen. The primary endpoint will be assessed at the end of the initial (Stage I) 12-week double-blind placebo-controlled primary treatment phase. After completing the Stage I treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsent to enter into the Stage II 12-week extension phase. The safety and efficacy of orally administered crofelemer will be evaluated for the prophylaxis of diarrhea in adult cancer patients receiving targeted cancer therapies with or without standard chemotherapy regimens. The assessment of the frequency of diarrhea will be measured by the number of loose and/or watery stools for the Stage I treatment period. Additional details about the trial can be viewed on the clinicaltrials.gov website. The National Clinical Trial number for the trial is NCT04538625.
"The initiation of this pivotal Phase 3 clinical trial for prophylaxis of diarrhea in cancer patients receiving targeted therapy regimens is a key milestone for Mytesi as we evaluate its potential to prevent and/or mitigate the intensity and severity of diarrhea experienced by cancer patients receiving targeted cancer therapy regimens, which may include various combinations with standard chemotherapy regimens," said
According to the
"We are excited to initiate Napo's pivotal trial of Mytesi for CTD, and happy that the initial tranche has increased from
"Managing cancer therapy related diarrhea provides a measure of control and return of dignity, as we've heard from patients. Moreover, reducing frequency of watery stools in cancer patients may allow better adherence to the therapeutic dosing of targeted therapies as well as chemotherapy, potentially leading to better clinical outcomes. Our pivotal trial for CTD will use the same formulation and dosing that is used for the currently commercialized Mytesi for the symptomatic relief of HIV/AIDS-associated diarrhea in adult patients receiving antiretroviral therapy," Conte continued.
Novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may activate intestinal chloride ion channel-mediated secretory pathways, leading to increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e. secretory diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs, including the recently approved irreversible pan-HER TKI neratinib (Nerlynx®), with occurrence ranging from 86% to >95% in published studies. Diarrhea is also a common side effect of some CDK 4/6 inhibitors.
Mytesi is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The only oral plant-based prescription medicine approved under FDA Botanical Guidance, Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption. Crofelemer was purified by Napo scientists and is sustainably harvested from the Amazon Rainforest.
Mytesi (crofelemer) 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%).
See full Prescribing Information 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 development of crofelemer for the potential additional indication of prophylaxis and symptomatic relief of CTD, the expectation that reducing frequency of watery stools in cancer patients may allow better adherence to the therapeutic dosing of targeted therapies as well as chemotherapy, potentially leading to better clinical outcomes, the expectation that the previously announced non-dilutive royalty financing transaction has the potential to total