Lechleri Croton Tree Revalled in Amazon, near Iquitos, Peru © Steven King & Nbsp
Interview with: Massimo Radalli, President and Chief Executive Officer, Napo Therapeutics
Massimo Radalli, PhD, is a European leader and entrepreneur of the pharmaceutical industry who has spent more than 30 years in innovation of therapies to treat rare diseases. He is president and chief executive officer of Napo Therapeutics, a pharmaceutical company created in Milan, Italy, in 2021 by Jaguar Health, based in California, to develop and market the crush of plant drugs in Europe, with a particular accent on rare gastroenterological diseases. Radalli explained to Global finance Why a sustainable derived medication of a Amazon forest tree can provide a new therapeutic option for patients with intestinal insufficiency due to microvillus inclusion disease and short intestine syndrome.
First of all, congratulations on your recent awards. What do you like most about recognition?
I am extremely honored to have been recognized by the CEO of Europe as “the CEO of the year in 2024 in the pharmaceutical industry”, and to have also been named “Best European Bio-Pharmaceutical Innovator CEO of the year 2024” by Europe. I believe this last price – of European CEO (sister brand of Global finance) – Once again, at the international level, my lifelong commitment to research and development of orphaned drugs for patient care and therapy with rare diseases. I’m grateful both for recognition and to have been able to spend decades to help patients with rare diseases around the world.
Can you tell us about intestinal failure?
Intestinal insufficiency is a condition where the intestines cannot adequately absorb the necessary water, macronutrients – carbohydrates, proteins and fats – micronutrients and electrolytes sufficient to maintain life. Patients with intestinal insufficiency due to rare diseases of microvillus inclusion disease (MVID) and short intestine syndrome (SBS-IF) suffer from devastating diarrhea and dehydration caused by these debilitating and life conditions and often require total parenteral nutrition (TPN) up to more than 12 hours per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week per week day.
The Sap Croton Lechleri… has a long story of medicinal use by indigenous peoples
TPN is a medical supply method where nutrients are delivered directly into a vein via a line IV, bypassing the digestive system, and chronic use of TPN has the risk of morbidity, infections, metabolic complications, liver and kidney and neurodevelopment delay problems. Limited therapeutic options exist for SBS-IIF beyond TPN, and there are no approved drug treatments for Mvid.
Mvid and SBS-IIF are devastating and life conditions. The greatest impact that can be had on a patient with intestinal insufficiency is the reduction in the quantity and time of TPN. We are always concerned about the quality of life of patients with Mvid and SBS-IIF, most of whom are children. They are unable to eat or drink and spend most of their monitoring hours connected to an IV.
Can you explain what type of Crofelemer product is and why it can provide a new therapeutic option for patients with intestinal insufficiency due to Mvid and SBS-IF?
Crofelemer is a drug -based drug de lastingly derived from the red bark sap of the Croton Lechleri tree – a kind of rapidly growing trees in common in the tropical forests of Colombia, Ecuador, Peru and Bolivia. The sap of Croton Lechleri, commonly known as Drago blood – which results in the “dragon blood” in Spanish – has a long story of medicinal use by indigenous peoples. Crofelemer works by reducing the secretion of chloride ions in intestinal light and by normalizing electrolytic and fluid balance. This is the active ingredient of the prescription medication approved by the FDA of Jaguar Health for the symptomatic relief of non -infectious diarrhea in adults with HIV / AIDS in antiretroviral therapy, and in the FDA prescription medication at FDA of FDA for the treatment of chemotherapy chemotherapy. As announced in April, the initial results of an test of proof of concept initiated by the researchers in the process of a new Crofelemer liquid formulation in the water show that the Crofelemer has reduced the required TPN and / or the additional intravenous fluids – collectively called parent support – in pediatric patients suffering from intestinal insufficiency because of the MVVI MVID and 12. These data also showed that the production of volume of stools reduces the creation and / or frequency of the aqueous stools and an increase in urine flow – an indicator of an improved nutritive absorption.
We are very excited by these initial results. While the short intestine syndrome affects around 10,000 to 20,000 people in Europe and almost the same number in the United States, Mvid is an ultra-rare condition-with an estimated prevalence of only a few hundred patients worldwide. Given this situation, the initial results on a very small number of MVID patients showing advantages with Crofelemer can allow us to explore ways for the accelerated regulatory approval of this indication, including the main program of the European Medicines Agency and the FDA breakthrough program.
Crofelemer is currently the subject of five clinical efforts for Mvid and SBS-IIF in the United States, EU and the Middle East-Two Phase two studies controlled by placebo that Napo Therapeutics manages and three trials initiated by researchers. Additional results of proof of concept of the tests initiated by researchers are expected throughout 2025.