Napo Therapeutics is a European pharmaceutical company led by a team of experienced professionals and headquartered in Milan (Italy). The company hase been incorporated in 2021 with the aim to develop and commercialize medicine products for rare disease and unmet medical needs.

Our name encapsulates our story: Napo is the river that runs through the Amazon territories where the plant Croton lechleri grows, from which the indigenous people extract the sap that contains our valuable active ingredient, Crofelemer following the principles of ethnobotany, a discipline based on the scientific and interdisciplinary study of local botany, genetics, traditions, psyche, as well as that empathetic link between humans and their natural ecosystem. The studies have led us to the definition of a specific technique that allows us to optimize the extraction of the active ingredient without using pesticides or preservatives.

We are collaborating with local communities to develop a sustainable cultivation and harvesting method that allows for the regeneration of soils in second-generation forests where the effects of logging are most severe and the protection of the activities of indigenous farming communities.

Napo Therapeutics is currently majority owned by Jaguar Health, a US pharma company listed at the NASDAQ stock exchange, a San Francisco, California-based commercial-stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicine for people suffering from gastrointestinal illnesses.

The primary focus is on providing access to the proprietary first-in-class plant-based medicine crofelemer in Europe to address significant rare/orphan disease indications.

Further, the company development strategy encompasses expanding the use of crofelemer to reduce symptoms among patients who are being diagnosed with other gastrointestinal (GI) dysfunctions and to develop an EU Market platform to serve biotech companies seeking to enter the EU rare diseases/orphan drugs market.

Napo Therapeutics’ initial focus is on pursuing the marketing authorization pathway from the European Medicines Agency (EMA) for crofelemer for important rare diseases: Short bowel syndrome (SBS) and congenital diarrheal disorders (CDD). Crofelemer has received orphan drug designation for SBS in both the EU and US, while we are expecting ODD approval for another condition called microvillus inclusion disease (MVID) in Q4 2022.

SBS is a complex condition characterized by severe malabsorption of fluids and nutrients due to surgical resection of bowel segments, congenital anomalies, or disease-associated loss of absorption. For SBS patients who endure the catastrophic loss of their bowel, the resulting excessive intestinal fluid output and lifelong restriction and adjustment of oral intake of food and liquids leads to the requirement to receive intravenous fluids for the majority of the day every day (parenteral nutrition).

This challenges the ability of SBS patients to carry out activities of daily living and has a significant impact on their daily quality of life. Furthermore, lifelong parenteral nutrition leads to potentially life-threatening complications like sepsis and organ failure.

Short bowel syndrome is a highly disabling and life-threatening disease currently lacking effective treatments. SBS is associated with significant morbidity and mortality, reduced quality of life and high healthcare costs.

Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027. Napo Therapeutics estimates that the SBS EU market size is approximately $1.0 billion Euros.

Crofelemer is a chloride ion channel modulator that boasts a unique anti-secretory mechanism of action in the world and may possibly provide an opportunity to reduce a patient’s requirement for parenteral nutrition and hence expand the possible benefits of crofelemer further along the value chain to disease management modification. The drug has a demonstrated good safety profile that is FDA-approved for a chronic utilization but for a different indication.

Napo Therapeutics is in charge of the development, registration and distribution across Europe of crofelemer for SBS patients that will be prescribed and distributed in a highly concentrated liquid and soluble powder formulation which is necessary to mitigate any insult to the intestinal tract of these kinds of highly ill patients.

Further ahead, Crofelemer may be used to reduce the diarrhea among patients who are being prescribed cancer related treatments – notably chemotherapy, Inflammatory bowel disease, and other GI dysfunctions.

Napo Therapeutics inaugurated its new offices in Milano last November 2021 and the European HQ employs 12 people (expected to grow up to 25 by 2024) and directly oversees the geographical expansion in the rest of Europe setting up our own subsidiaries in the major EU countries.

Our key near-term milestones are to start the pivotal clinical trial along with expediting Early Access Programs (EAPs) in key major EU markets by H1 2023. Napo Therapeutics has the ambition to prepare an IPO process starting from H2 2023.

The Napo Way is the circular action model that defines our essence: from nature we draw the tools for human health care and to nature we seek to give back, striving to preserve the ecosystem in full compliance with the principles of environmental and social sustainability.

For Napo Therapeutics, this is a clear identity choice that becomes a sustainable and innovative business strategy: the well-being and growth of people represent goals and results.