Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today provided an update on its ongoing efforts to address U.S. Food and Drug Administration (FDA) considerations cited in the Complete Response Letter (CRL) issued to the Company by the FDA on July 2, 2021, pertaining to comparability between the Company's planned teplizumab commercial product and clinical drug product used in historical trials of teplizumab.
On November 18, 2021, the Company had a Type A meeting with the FDA to discuss the population pharmacokinetic (popPK) model to be used for the purpose of planned commercial and clinical drug product comparison. In preliminary meeting comments, the FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic (PK/PD) substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes (T1D) patients (Commercial Product N~30 patients, Clinical Drug Product N~130 patients).
The Company's preliminary analysis from the popPK model produced the following top-line results:
Geometric mean of the ratio of commercial to clinical drug product [90% Confidence Interval (CI)]
83.2% AUC Infinity [CI: 76.9 – 89.9]
85.3% AUC Day 13 [CI: 78.0 – 93.3]
86.5% CMAX [CI: 83.9 – 89.3]
These results are not final and are subject to ongoing review of both the data and the popPK model by the FDA and the Company.
As anticipated, given teplizumab's target mediated mechanism of clearance, the difference in exposure (AUC Day 13 and 0-infinity) between commercial product and clinical drug product observed in a prior single, fractional low dose PK/PD study in healthy volunteers is greatly reduced when the products are administered and compared in accordance with the higher therapeutic dosing regimen used in T1D patients. Along with previously reported physicochemical and pharmacodynamic data, as well as the immunogenicity and safety profiles, it is the Company's current opinion that, collectively, these preliminary results support comparability of the commercial product and clinical drug product. The FDA, the ultimate decision maker on the matter, is conducting an independent review of the data and may have a different opinion. The Company looks forward to further discussing these results with the FDA to support the FDA's review.
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