Clinical-stage biopharmaceutical company Provention Bio (PRVB:NASDAQ), which is focused developing therapeutics than are able to intercept and preventing immune-mediated diseases, late last week announced "its intent to resubmit the teplizumab Biologics License Application (BLA) for the delay of clinical type 1 diabetes in at-risk individuals following its Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration (FDA)."
Provention Bio advised that the main purpose of the pre-BLA resubmission meeting was to gain specific feedback from the FDA regarding the company's proposed clinical pharmacology data package, which the firm stated "includes data and analysis from the pharmacokinetic/pharmacodynamic (PK/PD) sub study completed by the Provention Bio to address the FDA's PK comparability considerations contained in the complete response letter (CRL) issued last July."
During the meeting, the FDA indicated that the initial data package presented by Provention Bio did not adequately support PK comparability due to the fact that "predicted primary PK parameters are indicative of a lower exposure."
The FDA proposed that in order to go forward with the process, the company instead should utilize PK modeling methodology to adjust the 14-day dosing regimen for the planned commercial product. The company agreed to the concept suggested by the FDA as the approach would seem to "match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80-125% range." Importantly, the FDA agreed that Provention Bio could go ahead and proceed with resubmission of the BLA provided it makes the recommended adjustments.
The company stated that in tandem with its resubmission of the BLA to meet the modified 14-day course of therapy that the FDA requires, the BLA filings will also include the firm's responses to various issues raised by the FDA during a Type A meeting in August 2021. The responses will be made to the answer the complete response letter's (CRL) chemical, manufacturing, and controls (CMC) and product quality considerations. Provention Bio stated that it expects to be ready to resubmit the modified BLA package in Q1/22.
Provention Bio's CEO and Co-Founder Ashleigh Palmer remarked, "We are very pleased and excited to be working towards resubmitting the teplizumab BLA, taking the FDA's feedback into account, which gets us another step closer to our goal of delivering teplizumab to individuals and their families who are at risk of developing end-stage, insulin-dependent type 1 diabetes…We could not be more appreciative of the high level of collaboration and guidance we've experienced throughout this regulatory review process under the FDA's Breakthrough Therapy Designation (BTD)."
"We look forward to re-submitting the BLA as soon as possible and facilitating the FDA's review and decision-making. We continue to prepare the Company for a potential launch of teplizumab with prudently gated spending and planning," CEO Palmer added.
Once submitted, the FDA is expected to review the BLA resubmission within 30 days for completion and accuracy. After that, the process can take to six months under Breakthrough Therapy Designation (BTD) and Priority Review procedures.
Provention Bio is a biopharmaceutical company based in Red Bank, N.J. that is engaged in developing and commercializing new therapies with the capability of intercepting and preventing serious immune-mediated disease. The company listed that it is presently investigating several products in pre-clinical and clinical studies that are focused on treatments for autoimmune diseases, including type 1 diabetes, celiac disease and lupus.
Provention Bio started off the day with a market cap of around $263.6 million with approximately 63.4 million shares outstanding and a short interest of about 5.6%. PRVB shares opened relatively unchanged today at $4.15 (-0.01, -0.24%) from Friday's $4.16 closing price. The stock has traded today between $4.13 and $5.65 per share and closed for trading at $5.36 (+$1.20 +28.85%).
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