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Results summary of St. Jude clinical trial: 

BUZZOFF

 
 

BUZZOFF: PHASE 1a, First-in-human, Dose-escalation Study of (+)-SJ000557733 (SJ733), an Oral, Novel Inhibitor of Plasmodium Falciparum Plasma Membrane Protein PFATP4

Why was this study done?

Malaria is a disease caused by a parasite that is passed to humans when an infected mosquito bites a person. About 3.4 billion people live in parts of the world where malaria is common. In many countries, malaria is one of the leading causes of illness and death. Over time, drugs that worked to treat malaria before may lose their ability to kill malaria. This is known as drug resistance.

This study tested a new drug, SJ733, that attacks and kills the malaria parasite (Plasmodium falciparum).

The study’s main goals were to:

  • See if SJ733 is safe and tolerated in healthy adults.
  • See how the body uses SJ733
  • Find the best dose of SJ733 when given with a drug called cobicistat. Cobicistat can “boost” other drugs, which means it could help SJ733 reach higher levels in the blood and/or stay in the body longer.

When was this study done?

The study opened in March 2016 and closed in March 2018.

What did the study consist of?

Healthy volunteers, without malaria, got 1 dose of SJ733 with or without cobicistat daily for up to 3 days.

What did we learn from this study?

This study gave the first information about the use of SJ733 in humans, and the use of cobicstat to boost SJ733 to help it work better.

Scientists learned that SJ733 was safe and well tolerated. The use of cobicistat to boost SJ733 was safe, well tolerated, and increased the levels of SJ733 in the blood.

What are the next research steps as a result of this study?

Scientists plan to study the use of SJ733 with and without cobicistat to treat malaria patients.

For more information

Please talk with your doctor about questions or concerns you have as a result of this study.

For more details about this study see: https://www.clinicaltrials.gov/ct2/show/NCT02661373.

Publications generated from this study:

Safety, Tolerability, Pharmacokinetics, and Antimalarial Efficacy of a Novel Plasmodium Falciparum ATP4 Inhibitor SJ733: A First-in-human and Induced Blood-stage Malaria Phase 1a/b Trial. Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Möhrle JJ, Gusovsky F, Bebrevska L, Guy RK. Lancet Infect Dis. 2020 Aug;20(8):964-975. 
https://pubmed.ncbi.nlm.nih.gov/32275867/

Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development. Gaur AH, Panetta JC, Smith AM, Dallas RH, Freeman BB 3rd, Stewart TB, Tang L, John E, Branum KC, Patel ND, Ost S, Heine RN, Richardson JL, Hammill JT, Bebrevska L, Gusovsky F, Maki N, Yanagi T, Flynn PM, McCarthy JS, Chalon S, Guy RK. EBioMedicine. 2022 Jun;80:104065.
https://pubmed.ncbi.nlm.nih.gov/35598441/

 
 
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