Jaguar Health (NASDAQ: JAGX) stock jumped about 16% in intraday trading after the company submitted clinical trial applications for Crofelemer in Europe for treating Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome (SBS).
Jaguar Health and its family companies Napo Pharmaceuticals and Napo Therapeutics, have taken significant strides in advancing the development of crofelemer, a novel plant-based prescription drug. Recently, the companies announced the submission of a Clinical Trial Application (CTA) to the Italian and German health authorities to kickstart a phase 2 clinical trial for treating short bowel syndrome (SBS) in adults with intestinal failure.
Simultaneously, Napo Therapeutics submitted a CTA to AIFA, the Italian health authority, for a clinical trial in pediatric patients with microvillus inclusion disease (MVID). In addition, the approval request process is underway for this trial in the United Arab Emirates in collaboration with Dubai Health. The MVID clinical trial is being conducted under a US Investigational New Drug (IND) in the US.
Management Commentary
Lisa Conte, President and CEO of Jaguar Health, expressed satisfaction with these important CTA submissions, emphasizing their significance in advancing the development efforts for crofelemer. Conte stated,
“This is a key regulatory milestone in our ongoing development efforts for a novel powder formulation of crofelemer for oral solution for patients with MVID and SBS with intestinal failure – two devastating and often catastrophic rare diseases for patients who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week.”
MVID, an ultra-rare congenital diarrheal disorder, and SBS with intestinal failure pose significant challenges for patients, often necessitating intensive parenteral nutrition (PN) support. With no approved drug treatments currently available, the initiation of clinical trials for crofelemer offers hope for patients suffering from these debilitating conditions.
Advancements in Crofelemer Development
Jaguar (NASDAQ: JAGX), along with Napo Pharmaceuticals and Napo Therapeutics, is also supporting investigator-initiated proof-of-concept studies of crofelemer for MVID and SBS in the US, EU, and Middle East/North Africa (MENA) regions, with results expected in 2024. Additionally, the FDA activated Napo Pharmaceuticals’ Investigational New Drug (IND) application for a novel formulation of crofelemer for the treatment of MVID in August 2023, paving the way for Jaguar to commence its planned US-based phase 2 trial for pediatric MVID patients.
The availability of published data from clinical investigations in MVID and SBS could potentially facilitate early patient access to crofelemer in specific EU countries, under their guidelines.
Jaguar Health (NASDAQ: JAGX) Stock Reaction
JAGX stock surged 15.74% to close at $0.3095 on Thursday. Its value increased by 5.56% this week. Trading activity has witnessed 66,173,579 (66.17 million) shares changing hands, lower than the average daily volume of 69.69 million.
