PRVB releases preliminary data, up 20% intraday:
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.
"We are very pleased that we were able to reach agreement with the FDA on progressing the popPK model, which enabled us to generate the comparability results being shared with you today," said Ashleigh Palmer, Co-Founder and CEO of Provention Bio. "We are encouraged by these preliminary results, which we believe are consistent with our understanding of the target mediated clearance mechanism of teplizumab and could potentially explain the differences observed in the previously reported single, fractional low dose PK/PD study in healthy volunteers. We look forward to continuing our discussions with the FDA as they conduct their own review of the data and determining the next steps in the pathway to the Company's goal of ultimately providing teplizumab to T1D patients who are at risk of developing end-stage insulin-dependent disease."
Additionally, at the Type A meeting held on November 18, 2021, the FDA expressed its concurrence with the Company proceeding to schedule a Type B, pre-Biologics License Application (BLA) re-submission meeting. |
