PRTX-100 is an investigational drug incorporating a highly purified form of Staphylococcal Protein A. The unblinded analysis included 41 patients recruited at five U.S. clinical sites in the first four dosing cohorts of the five-cohort study through completion of the 25-week study protocol.
The preliminary results indicated that PRTX-100 was generally safe and well tolerated and the Adverse Event (AE) profile was consistent with prior trials results. There were no immediate hypersensitivity reactions, nor any treatment-related Serious Adverse Events (SAEs) evident and no expedited reports to the
Moreover, the study revealed positive effects of PRTX-100 treatment on certain measures of disease activity, although these effects were not statistically significant. At the higher doses, PRTX-100 showed activity comparable to existing well known biologics with apparent onset of action occurring subsequent to the fifth and final dose. For example, four weeks following the last PRTX-100 dose (Day 57), 32% of active-treated and 13% of placebo-treated patients had attained an ACR50 response. At day 113, 29% of the active-treated patients who received 6 or 12 mcg/kg PRTX-100 plus methotrexate achieved DAS28-CRP scores less than 2.6 (remission), while the placebo-treated patients showed no remission. Notably, among all patients treated with PRTX-100, 43% had DAS28-CRP < 3.2 (low disease activity) on both Day 57 and Day 85, while only 14% of placebo-treated patients showed such a reduction in RA disease activity on these days.
The Company expects to submit an interim clinical study report to the
Additionally, 16 out of 20 patients in the final cohort of the 104 Study (Cohort 5) have completed dosing though Day 85, and per protocol, all patients will receive their last doses in
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