Provention Bio Inc. (NASDAQ: PRVB) stock gained by 15.06% in the current market trading session. Provention Bio, Inc. is a pharmaceutical firm dedicated to the advancement of investigational medicines which can be used to diagnose and reduce severe and life-threatening immune-mediated diseases.

PRVB stock’ Significant Update

Provention Bio gave an update on its continuing attempts to address FDA considerations cited in the Company’s Complete Response Letter (CRL) released on July 2, 2021, relating to comparability between the Company’s intended teplizumab commercial product and clinical drug product used in historical teplizumab tests.

The Company conducted a Type A meeting with the FDA on November 18, 2021, to address the population pharmacokinetic (popPK) model that will be utilized for anticipated commercial and clinical medication product comparisons. The Food and drug administration approved the Company’s plan to populate the popPK model with data from patients undergoing therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes (T1D) patients, according to preliminary meeting remarks.

The following are the main results of the Company’s preliminary study using the popPK model:

Geometric mean of the ratio of commercial to clinical drug product [90% Confidence Interval (CI)]

• 2% AUC Infinity [CI: 76.9 – 89.9]
• 3% AUC Day 13 [CI: 78.0 – 93.3]
• 5% CMAX [CI: 83.9 – 89.3]

Ashleigh Palmer, Co-Founder, and CEO of Provention Bio commented that,

They are very delighted that they were able to obtain a deal with the FDA on moving forward with the popPK model, allowing them to produce the comparability results that you are seeing today. These first findings are encouraging, as they appear to be aligned with their understanding of teplizumab’s target-mediated clearance process. This might explain the discrepancies found in a single, fractional low dosage PK/PD investigation in healthy volunteers previously described. They intend to continue their conversations with the FDA as they examine the data and determine the next stages in the Company’s goal of eventually giving teplizumab to T1D patients who are at risk of developing final stage insulin-dependent disease.