Jaguar Health Announces Presentation of an Investigator-initiated Evaluation of Crofelemer for a Severe Congenital Diarrheal Disorder at 2022 Digestive Disease Week

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) presented a study on crofelemer as a potential treatment for Microvillus Inclusion Disease (MVID), a severe congenital diarrheal disorder, at Digestive Disease Week 2022. The study, led by Dr. Jay Thiagarajah, demonstrates crofelemer's potential for managing symptoms and electrolyte balance in MVID patients. This research supports Napo Therapeutics' application for Orphan Drug Designation from the European Medicines Agency. Crofelemer holds ODD for short bowel syndrome in both the EU and US.

Positive

• Study results support the efficacy of crofelemer for MVID treatment.
• Potential for Orphan Drug Designation application to enhance market access.
• Crofelemer already has ODD for short bowel syndrome, indicating regulatory support.

Negative

• None.

Microvillus inclusion disease (MVID) is a life-threatening and rare autosomal recessive disease that affects newborns and children resulting in significant morbidity and mortality from severe secretory diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / May 24, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced the presentation of an investigator-initiated in vitro study evaluating the efficacy of crofelemer, the company's plant-based prescription drug, as a potential anti-diarrheal to mitigate the consequences of microvillus inclusion disease (MVID), a severe congenital diarrheal disorder (CDD), at Digestive Disease Week^® (DDW 2022), which took place May 21-24, 2022 in San Diego, CA.

"Microvillus inclusion disease (MVID) is a life-threatening and rare autosomal recessive disease that affects newborns and children resulting in significant morbidity and mortality from severe secretory diarrhea," said Pravin Chaturvedi, PhD, Jaguar Health's Chief Scientific Officer and Chair of the company's Scientific Advisory Board. "We expect the results of this study to be supportive of Napo Therapeutics' Orphan Drug Designation (ODD) application to the European Medicines Agency (EMA) for crofelemer for this congenital diarrheal disorder (CDD). Napo Therapeutics is the Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe."

This study characterized for the first time the cellular phenotype of MVID using primary patient-derived duodenal enteroids. The results of this study demonstrate that crofelemer has the clinical potential for symptomatic therapy and electrolyte and fluid management in MVID patients. Click here to view the study abstract.

This study was conducted and presented by Jay Thiagarajah, MD, PhD, who is Co-Director of the Congenital Enteropathy Program, and an Attending Physician in the Division of Gastroenterology, Hepatology and Nutrition, at Boston Children's Hospital, Harvard Medical School, where Dr. Thiagarajah also serves as Assistant Professor of Pediatrics.

MVID patients commonly face intestinal failure - a catastrophic health situation that also often afflicts patients with short bowel syndrome (SBS). Napo Therapeutics has been granted ODD for crofelemer for SBS in the European Union by the EMA, and Jaguar Health's wholly owned US subsidiary, Napo Pharmaceuticals, has been granted ODD for crofelemer for SBS in the US by the FDA.

DDW is an annual meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

About Jaguar Health, Napo Pharmaceuticals, and Napo Therapeutics

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 gastrointestinal distress, including chronic, debilitating diarrhea. Napo Pharmaceuticals, Inc., Jaguar Health's wholly owned subsidiary, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Crofelemer, our drug product candidate, is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe.

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar Health's expectation that the results of this study will be supportive of Napo Therapeutics' ODD application to the EMA for crofelemer for MVID. 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.

CONTACT:
Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View source version on accesswire.com:
https://www.accesswire.com/702443/Jaguar-Health-Announces-Presentation-of-an-Investigator-initiated-Evaluation-of-Crofelemer-for-a-Severe-Congenital-Diarrheal-Disorder-at-2022-Digestive-Disease-Week

FAQ

What was the focus of Jaguar Health's study presented at Digestive Disease Week 2022?

The study evaluated crofelemer's efficacy as a potential treatment for Microvillus Inclusion Disease (MVID).

How does crofelemer relate to orphan drug designation for MVID?

The study results aim to support Napo Therapeutics' application for Orphan Drug Designation from the European Medicines Agency for crofelemer in treating MVID.

What is the significance of Jaguar Health's research in relation to short bowel syndrome?

Jaguar Health's crofelemer has already received Orphan Drug Designation for short bowel syndrome in both the EU and the US.

Who presented the study on crofelemer at Digestive Disease Week 2022?

The study was presented by Dr. Jay Thiagarajah, Co-Director of the Congenital Enteropathy Program at Boston Children's Hospital.

What is the main impact of MVID on patients?

Microvillus Inclusion Disease leads to severe secretory diarrhea, resulting in significant morbidity and mortality in affected newborns and children.