Merck Announces Successful Phase III Trial of Single-Dose Arpraziquantel, Achieving ~90% Cure Rate in Preschool-Aged Children with Schistosomiasis

Schistosomiasis (Image source: caribbeannationalweekly.com)

November 17, 2021 /BioValleyBIOON/ -- Merck and the Pediatric Praziquantel Consortium (PPC) recently announced the evaluationSingle doseArpraziquantel for the Treatment of Schistosomiasis in Preschool Children (3 Months to 6 Years)Key Phase 3Clinical TrialReached the primary endpoint of clinical cure.

Schistosomiasis is a neglected tropical disease, which is a parasitic disease. It is estimated that 50 million preschool children are infected with schistosomiasis, and these children currently have no treatment options. Arpraziquantel is specifically tailored for these children and is part of the ongoing effort to eliminate this parasitic disease. According to this Phase 3Clinical TrialAccording to the data, Merck plans to submit the regulatory application for arpraziquantel to the European Medicines Agency (EMA).

Arpraziquantel is derived from praziquantel., an orally disintegrating tablet developed by PPC. PPC is a public-private partnership led by Merck through its Global Health Institute, aiming to bridge the current treatment gap for approximately 50 million preschool-aged children with schistosomiasis.

Phase 3 trials were conducted by Félix Houphouët-Boigny University (Bovani University) in Côte d'Ivoire and the Kenya Medical Research Institute, and supported by the Global Health Innovative Technology Fund (GHIT) and European and developing countries.Clinical TrialPartnership (EDCTP) support.

In this completed phase 3 trial, pediatric patients aged 3 months to 6 years infected with Schistosoma mansoni or Schistosoma haematobium were enrolled in different age groups and received a single dose of arpraziquantel.The results showed,A single dose of arpraziquantel is highly effective for treating Schistosoma mansoni (at a dose of 50 mg/kg) and Schistosoma haematobium (at a dose of 60 mg/kg), with cure rates approaching or exceeding 90%.The primary endpoint of clinical cure is defined as no parasitic eggs in stool (Schistosoma mansoni) 17 to 21 days post-treatment, or no parasitic eggs in urine (Schistosoma haematobium) 17 to 21 days post-treatment, and meeting the predefined criteria for success 35 to 40 days post-treatment.

Two doses of arpraziquantel treatment showed good safety, tolerability, and improved palatability in preschool-aged children. No new potential risks or safety issues were identified.

Schistosomiasis is a chronic disease and one of the most common and devastating parasitic diseases in tropical countries. It is estimated that more than 240 million people worldwide are infected, and approximately 200,000 people die from it each year. This disease is transmitted by flatworms and is widely distributed in tropical and subtropical regions, where the majority of the population lacks access to clean water and sanitation facilities. People become infected with this parasite through contact with freshwater, such as during work, swimming, fishing, or washing clothes. Tiny larvae can penetrate human skin, enter blood vessels, and attack internal organs. The infection rate is particularly high among children.

Currently,The standard care therapy for treating schistosomiasis is praziquantel. This drug is safe and effective, and is suitable for school-age children and adults.However, to date, no suitable drug has been found for preschool children. Arpraziquantel aims to bridge this treatment gap.

Arpraziquantel contains the pharmacologically active enantiomer of praziquantel.. This new type of tablet is small in size, can be orally dispersed, dissolved in the mouth or in water, has taste characteristics acceptable to children, and can withstand the challenges brought by tropical climates. Arpraziquantel was developed by Japan's Astellas, subsequently optimized by Merck KGaA, and then transferred to Brazil's Farmanguinhos for clinical production. (Bioon.com)

Source of the original text:Merck Announces Positive Phase III Results for Arpraziquantel as Part of its Schistosomiasis Elimination Program