ABO809 / Novartis - LARVOL DELTA

Development of a Phase 1 Cryptosporidiosis Controlled Human Challenge Model in Healthy Volunteers Using Current Good Manufacturing Practice Cryptosporidium Parvum Oocysts and Conducted Under an Investigational New Drug Application. (PubMed, J Infect Dis) - P1 | "The Cryptosporidium CHIM, developed using CGMP-compliant oocysts, reliably induced infection and symptoms, providing a robust monoinfection model for evaluating new therapeutics and vaccines."

IND • Journal • P1 data • Infectious Disease • Pediatrics

Development of a current Good Manufacturing Practice-compliant Process for Producing Cryptosporidium parvum oocysts for Clinical Use. (PubMed, J Infect Dis) - "We describe a robust cGMP-compliant and qualification process for C. parvum oocysts that enables CHIM studies in healthy adults. Thereby opening avenues to evaluate efficacy of novel therapeutics and vaccines to treat cryptosporidiosis."

Journal • Infectious Disease • Pediatrics

CRYPTONITE: Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

CRYPTONITE: Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Infectious Disease

Development of a Phase 1 Cryptosporidiosis Controlled Human Challenge Model in Healthy Volunteers using IND-enabled GMP-compliant C. parvum oocysts (ABO809) (ASTMH 2025) - "All subjects with confirmed Cryptosporidium infection were treated with nitazoxanide. Overall, Cryptosporidium CHIM was successfully developed for the first time using IND-enabled GMP-compliant C. parvum oocysts (ABO809) causing diarrhea and symptoms of cryptosporidiosis in >50% of participants. Cryptosporidium infection and symptoms were observed at an incidence and duration amenable to an investigation of new therapeutics."

Clinical • Late-breaking abstract • P1 data • Infectious Disease

Comparative efficacy and safety of anti-cryptosporidial agents: an in vitro study on nitazoxanide, halofuginone lactate, KDU731, and paromomycin against Cryptosporidium parvum. (PubMed, Front Microbiol) - "This study offers new insights into the relative efficacy and safety of various anti-cryptosporidial compounds, highlighting their stage-specific effects on C. parvum and the consequential impacts on host cells. Identifying safe and effective anti-cryptosporidial agents contributes significantly to the One Health approach, which emphasizes the importance of integrated strategies in controlling zoonotic diseases."

Journal • Preclinical • Infectious Disease

A Pyridyl-Furan Series Developed from the Open Global Health Library Block Red Blood Cell Invasion and Protein Trafficking in Plasmodium falciparum through Potential Inhibition of the Parasite's PI4KIIIB Enzyme. (PubMed, ACS Infect Dis) - "Parasites selected for resistance to a related compound, MMV396797, were also resistant to WEHI-518 as well as KDU731, an inhibitor of the phosphatidylinositol kinase PfPI4KIIIB, suggesting that this kinase is the target of the pyridyl-furan series...MMV396797-resistant parasites possess an E1316D mutation in PfPKI4IIIB that clusters with known resistance mutations of other inhibitors of the kinase. Building upon earlier studies that showed that PfPI4KIIIB inhibitors block the development of the invasive merozoite parasite stage, we show that members of the pyridyl-furan series also block invasion and/or the conversion of merozoites into ring-stage intracellular parasites through inhibition of protein secretion and export into red blood cells."

Journal • Infectious Disease • Malaria

Study of Efficacy and Safety of ABO809 in Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Study of Efficacy and Safety of ABO809 in Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=60 ➔ 30

Enrollment change • Enrollment closed • Infectious Disease

Study of Efficacy and Safety of ABO809 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease