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news.The French National Agency for Medicines and Health Products (ANSM) has approved Protalex's clinical trial application to initiate a Phase Ib study of PRTX-100 to treat persistent/chronic immune thrombocytopenia (ITP) in adult patients.
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With the approval, the company now intends to begin the PRTX-100-203 trial at several sites in France with patient enrollment expected to start by this year end.
Furthermore, PRTX-100 has secured positive opinion from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) as an orphan medicinal product for the treatment of ITP.
The approval to start the trial and the positive COMP opinion follow the company’s previously announced initiation of a US Phase I/II clinical trial of PRTX-100 in adult ITP patients (PRTX-100-202 Study) and receipt of orphan drug designation (ODD) for the drug to treat ITP from the Office of Orphan Products Development of the US Food and Drug Administration.
Protalex ITP Programmes vice president Richard Francovitch said: "The 203 Study is designed to evaluate the safety and efficacy of PRTX-100 in a range of doses and, along with the recently initiated US-based 202 Study, will provide important data to support further development plans in ITP.
"Protalex is also very pleased to have received a positive opinion from the EMA COMP on the PRTX-100 application for ODD.
"Based on preclinical observations and data generated in prior clinical trials in patients with RA, we believe PRTX-100 represents a promising new approach for the treatment of ITP."
PRTX-100, a new generation immunomodulatory therapy and a purified form of Staphylococcal protein A (SpA), is being evaluated to treat autoimmune diseases such as rheumatoid arthritis (RA) and ITP.
SpA is a bacterial protein showed by Protalex and others to affect immune function in various preclinical studies.
The open-label, dose-escalating 203 study will enroll about 30 patients in as many as five cohorts.
In the trial, each patient will receive four weekly intravenous doses of PRTX-100 and will be monitored for up to 48 weeks thereafter.
The primary endpoint of the 203 trial is safety and secondary endpoints include platelet response to PRTX-100, immunogenicity and pharmacokinetics.