arpraziquantel (L-PZQ ODT) / EMD Serono - LARVOL DELTA

Socio-cultural and structural barriers influencing parents' knowledge and access to information on schistosomiasis in children around Ugandan Lakes. (PubMed, PLoS Negl Trop Dis) - "Carefully designed information campaigns tailored to local circumstances and health literacy needs should be carried out by trained VHTs and preferably supported by health professionals and the local leadership structure. These components are essential to inform parents/guardians of PSAC, enabling them to make well-informed decisions for their children's health."

Journal • Infectious Disease • Pediatrics

Effects of praziquantel on early life stages of Grass carp, Ctenopharyngodon idella. (PubMed, Vet Med (Praha)) - "Concentrations of 2, 4 and 6 mg/l praziquantel caused significantly (P < 0.01) higher mortality and slower growth compared with controls. Among the groups, no histological changes were detected in tissues. For the early life of grass carp, praziquantel is safe at concentrations ≤1 mg/l."

Journal

Considerations and expectations for the administration of dispersible arpraziquantel to young children: a landscape analysis. (PubMed, Int Health) - "Our findings confirm that child-friendly drug formulations mitigate several operational constraints related to the dosing and administration in young children. The introduction of this novel child health intervention into routine platforms and programs requires solid training and careful communication by engaging with communities, caregivers, healthcare workers and decision-makers to ensure acceptance and future uptake of treatment."

Journal • Infectious Disease • Pediatrics

ADOPTpilot: Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: a Small-scale Public Health Intervention Study (clinicaltrials.gov) - P=N/A | N=18500 | Recruiting | Sponsor: Peter Steinmann | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Contextual factors influencing schistosomiasis treatment and identification of delivery platforms for arpraziquantel in hard-to-reach areas and populations in Homa Bay County, Kenya. (PubMed, PLOS Glob Public Health) - "Based on the reported barriers, the door-to-door distribution approach by community health promoters was proposed by parents and key informants as the most feasible platform for community sensitization, mobilization, and arPZQ delivery. To achieve high arPZQ treatment coverage for all at-risk PSAC, and promote ownership and sustainability of the program, the door-to-door approach is the most promising platform to deliver treatment and public health promotion in marginalized hard-to-reach island populations of Lake Victoria, Kenya."

Journal • Infectious Disease

ADOPTpilot: Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: a Small-scale Public Health Intervention Study (clinicaltrials.gov) - P=N/A | N=18500 | Not yet recruiting | Sponsor: Peter Steinmann

New trial • Infectious Disease

Suitable Communication Strategies Prior to the Introduction of a Novel Pediatric Treatment Option < Schistosomiasis in Kenya (ASTMH 2024) - "The Pediatric Praziquantel Consortium has developed arpraziquantel, a novel paediatric treatment option for PSAC. To reach audiences with preferences for different information sources and message formulations, we recommend designing a sensitization strategy that employ a variety of channels. Emphasis on key messaging about the drug’s safety is needed to build trust in advance of its roll-out"

Clinical • Infectious Disease • Pediatrics

Identifying platforms for optimal delivery of a novel pediatric praziquantel formulation for schistosomiasis treatment in hard-to-reach areas and populations in Kenya - What are the key contextual factors? (ASTMH 2024) - "A new formulation of praziquantel, arpraziquantel (arPZQ), has been developed for preschool-aged children (PSAC) to fill the treatment gap for this age group in schistosomiasis control and elimination programs. Door-to-door distribution approach by community health volunteers was proposed by parents and key informants as the most feasible platform for community sensitization, mobilization, and arPZQ delivery. To achieve high arPZQ treatment coverage for all at-risk PSAC, and promote ownership and sustainability of the program, the door-to-door approach is the most promising platform to deliver treatment and public health promotion in marginalized hard-to-reach settings in the Lake Victoria Region of Kenya."

Clinical • Infectious Disease • Pediatrics

Orodispersible Arpraziquantel development and next steps (ASTMH 2024) - No abstract available

88 - Advancing Research to Improve Treatment of Neglected Tropical Diseases in Children (ASTMH 2024) - "Peter Steinmann of the Swiss TPH will discuss the experience of ADOPT (Adoption of Levo-Praziquantel 150mg for schistosomiasis by endemic countries), an initiative of the Pediatric Praziquantel Consortium, which aims to facilitate large-scale delivery of this new treatment to preschool age children in Africa. Olaf Valverde of the Drugs for Neglected Diseases initiative will discuss recent clinical trials in pediatric populations to treat human African trypanosomiasis, including an ongoing trial (ACOZI-Kids), to evaluate acoziborole for treatment of Stage 1 and Stage 2 sleeping sickness caused by T.b.gambiense...About 25% of people affected by mycetoma in Sudan are children, and the disease has long lacked a viable treatment, but there are recent therapeutic advances to share. Saschveen Singh of Medecins sans Frontieres will discuss treatment and access challenges for children with cutaneous and visceral forms of leishmaniasis, as well as efforts to confront the burden of..."

Clinical • Infectious Disease • Narcolepsy • Pediatrics • Sleep Disorder

Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research Study (clinicaltrials.gov) - P=N/A | N=225 | Active, not recruiting | Sponsor: Technical University of Munich | Recruiting ➔ Active, not recruiting | N=3000 ➔ 225 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment change • Enrollment closed • Trial primary completion date • Infectious Disease

Efficacy, safety, and palatability of arpraziquantel (L-praziquantel) orodispersible tablets in children aged 3 months to 6 years infected with Schistosoma in Côte d'Ivoire and Kenya: an open-label, partly randomised, phase 3 trial. (PubMed, Lancet Infect Dis) - P3 | "Arpraziquantel, a first-line orodispersible tablet, showed high efficacy and favourable safety in preschool-aged children with schistosomiasis."

Journal • P3 data • Infectious Disease • Pain

Epidemiology of pediatric schistosomiasis in hard-to-reach areas and populations: A scoping review protocol. (PubMed, F1000Res) - "The Pediatric Praziquantel Consortium has developed an orally dispersible praziquantel formulation (arpraziquantel) and is facilitating its adoption for schistosomiasis control by endemic countries through the ADOPT program - an implementation research program that paves the way for the large-scale delivery of the child-friendly formulation to treat schistosomiasis in preschool-aged children in endemic countries. A meta-analysis will be conducted if indicated. Relevance : The results will provide insights into the burden of schistosomiasis among marginalized PSAC, aiming to produce evidence on the need for inclusion of this population when designing the expansion of preventive chemotherapy programs."

Journal • Review • Infectious Disease • Pediatrics

"📝#NoticiasBreves_iSanidad| La @EMA_News valida la solicitud regulatoria para el arpraziquantel, una #terapia para la #esquistosomiasis en niños 👦 @merck_es @GHITFund @AstellasEurope https://t.co/jdjEkjvtAz" (@isanidad)

"#AbeonaTherapeutics to Participate in the #CantorFitzgeraldCellandGeneticMedicinesConference $ABEO https://t.co/L0pzQsxfKN" (@1stOncology)

"Our article on how to approach CRT non-responders is out. Grateful to @JagSinghMD and Lana Tsao for the opportunity! https://t.co/L2pZqDSOKi" (@HImmoLehmann)

"$STLA Stellantis Invests €33 Million in Global Testing Hubs for Cutting-Edge Engineering https://t.co/LqPZQrfSf0" (@stock_titan)

Efficacy and safety of arpraziquantel (L-praziquantel orodispersible tablets) in Schistosoma-infected children aged 3 months to 6 years of age: an open-label phase III study (ECCMID 2022) - No abstract available

Clinical • P3 data

Adoption of L-PZQ for Schistosomiasis by Endemic Counties - Social Science Research Study (clinicaltrials.gov) - P=N/A | N=3000 | Recruiting | Sponsor: Technische Universität München

New trial • Infectious Disease

Effects of praziquantel isomers on the proliferation and activation of the LX-2 human hepatic stellate cell line (PubMed, Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi) - "Both L-PZQ and D-PZQ inhibit the proliferation and activation of LX-2 cells, and D-PZQ shows a higher inhibitory activity than L-PZQ."

Journal • Preclinical • TGFB1

L-PZQ ODT in Schistosoma Infected Children (clinicaltrials.gov) - P3; N=311; Completed; Sponsor: Merck KGaA, Darmstadt, Germany; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study. (PubMed, PLoS Negl Trop Dis) - P1 | "The new paediatric-friendly formulations dispersed in water were both found to be more palatable than the existing standard formulation of PZQ. There may be gender and age effects on the assessment of palatability. Further research is needed for assessing efficacy and tolerability of the newly ODTs Praziquantel drug in younger children."

Clinical • Journal • Infectious Disease • Pediatrics

Two approaches for the synthesis of levo-praziquantel. (PubMed, Org Biomol Chem) - "The key intermediate (R)-1-aminomethyl tetrahydroisoquinoline could be obtained either by chiral resolution with a rational reuse of the S-isomer or by mechanochemical enantioselective synthesis that refrained from using a bulky toxic solvent. The efficiency and scalability of both the developed routes were demonstrated and desired target product was obtained in a satisfactory yield with excellent enantiopurity (>99%), offering practical, concise and environmentally friendly alternatives to access R-PZQ."

Journal

L-praziquantel Orodispersible Tablets (L-PZQ ODT) in Schistosoma Infected Children (clinicaltrials.gov) - P3; N=311; Recruiting; Sponsor: Merck KGaA, Darmstadt, Germany; Trial completion date: Aug 2020 ➔ May 2021; Trial primary completion date: Aug 2020 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date

The impact of intensive versus standard anthelminthic treatment on allergy-related outcomes, helminth infection intensity and helminth-related morbidity in Lake Victoria fishing communities, Uganda: results from the LaVIISWA cluster randomised trial. (PubMed, Clin Infect Dis) - "In an open, cluster-randomized trial (ISRCTN47196031), we randomized 26 high-schistosomiasis-transmission fishing villages in Lake Victoria, Uganda, in a 1:1 ratio to receive community-wide intensive (quarterly single-dose praziquantel plus albendazole daily for 3 days) or standard (annual praziquantel plus 6 monthly single-dose albendazole) MDA...This could be due to sustained low-intensity infections, thus a causal link between helminths and allergy outcomes cannot be discounted. Intensive community-based MDA has limited impact in high-schistosomiasis-transmission fishing communities, in the absence of other interventions."

Clinical • Journal • Hematological Disorders • Immunology