Provention Bio, Inc. (PRVB) experienced an increase of 22.06% in aftermarket following the announcement of Resubmitting Biologics License Application for Clinical Type 1 Diabetes. However, the last trading session concluded at $3.4 with a decrease of 6.59%.
Resubmitting Biologics License Application – What’s up?
On 27th January 2022, PRVB announced that it has resubmitted the teplizumab Biologics License Application (BLA) for the control of clinical type 1 diabetes. In the BLA resubmission, the Company will present a hybrid 14-day treatment plan to alleviate the FDA’s comparability concerns. This will be based on the Company and FDA’s agreed-upon PK modeling and the Company’s experience with various dosages and regimens evaluated in earlier clinical studies. According to an agreement reached with the FDA at a Type A meeting conducted in August last year, the BLA resubmission will contain responses to the CRL’s Chemical, Manufacturing, and Controls (CMC) and quality control concerns. In the first quarter, PRVB expects to be able to resubmit the BLA.
Now what?
PRVB is ecstatic to be working on resubmitting the teplizumab BLA, which will move the firm one step closer to its goal of giving teplizumab to family members at risk of developing end-stage, insulin-dependent type 1 diabetes while taking into account the FDA’s feedback.
Furthermore, the company appreciates the FDA’s Breakthrough Therapy Designation team’s high level of participation and assistance during this regulatory review process (BTD).
Not only that, but the company plans to resubmit the BLA as quickly as possible, assisting the FDA with its review and decision. The team continues to prepare PRVB for a future launch of teplizumab with carefully controlled spending and planning.
Initiation of the Phase 2a PREVAIL-2 Study of PRV-3279 – Latest News
PRVB stated on 20th January 2022 that Phase 2a PREVAIL-2 study of PRV-3279 has been started. PRV-3279 combines two important immune protein targets to change their interactions in a smart way. Moreover, CD32B is a natural activator of B cells and CD79B is part of the B cell receptor. Arthritis and Clinical Immunology Program has led global efforts to produce more interpretable trials. The use of a B cell gene profile to stratify and pre-define subsets in PREVAIL-2 helps to identify patients who will benefit from PRV-3279 treatment in the future.
What’s Next?
PRV-3279 has an elegant mode of action which is to intercept and ameliorate the pathophysiology of lupus. In addition, PRVB believes that PRV-3279 allows for fast suppression of active B cells while sparing non-activated B cells from depletion. Last but not the least, PREVAIL-2 data is expected to be available in the first half of 2024.
