Pure Biologics commissioned a phase 0 clinical study of PB003 and PB004molecules

Pure Biologics has entered into an agreement with the American Presage Biosciences regarding the first administration of PB003 and PB004 molecules to humans - the so-called phase 0 clinical trial, the company said. Phase 0 clinical trials are human studies aimed at obtaining information on the pharmacodynamics (mechanism of action of a drug) and pharmacokinetics (processes that a drug enters the human body undergoes), it was explained.

“The purpose of the study contracted by the company will be to evaluate the activity of drug candidates in the PB003 and PB004 projects in the human tumor microenvironment (TME), which will enable the assessment of the pharmacodynamic response in the heterogeneous tumor environment. The study will be conducted simultaneously for many molecules, including in combination with other drugs.

Pursuant to the contract, Presage Biosciences undertook, among others, to: to prepare the company for meetings with the FDA, advice on the submission of eIND (exploratory Investigational New Drug) (estimated date Q3/Q4 2023), qualification of clinical centers, conducting a phase 0 clinical trial, data management, monitoring and analysis of results. According to the contract, up to 15 patients will be recruited for the study.

Pure Biologics is a Polish biopharmaceutical company focused on discovering and developing biological drugs and developing extracorporeal therapies. The company conducts research using its own technological platforms for the selection of active particles - antibodies and aptamers. In December 2020, the company moved its listings to the main market of the Warsaw Stock Exchange from the NewConnect market, where it had been listed since December 2018.

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