RED BANK, N.J., Jan. 27, 2022 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today 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).
The purpose of the Type B pre-BLA resubmission meeting was to
discuss FDA feedback and obtain agreement on Provention's proposed
clinical pharmacology data package, including data and analysis
from the pharmacokinetic/pharmacodynamic (PK/PD) substudy completed
by the Company to address the FDA's PK comparability considerations
contained in the complete response letter (CRL) issued last July.
In preliminary meeting comments, the FDA noted that the data
package presented does not adequately support PK comparability
because predicted primary PK parameters are indicative of a lower
exposure. To address this concern, the FDA proposed, and the
Company agreed, to use PK modeling to adjust the 14-day dosing
regimen for the planned commercial product 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. On this basis, the FDA
agreed that Provention could proceed to resubmit the BLA.
Based on the Company and FDA's agreed upon PK modeling, and the
Company's experience with various doses and regimens tested in
prior clinical trials, the Company will propose in the BLA
resubmission a modified 14-day course of therapy to address the
FDA's comparability considerations. The BLA resubmission will also
include responses to address the CRL's Chemical, Manufacturing, and
Controls (CMC) and product quality considerations, as agreed with
the FDA at a Type A meeting held in August last year. The Company
believes it will be in a position to resubmit the BLA in the first
quarter.
"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,"
said Ashleigh Palmer, Co-Founder and
CEO of Provention Bio. "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."
Under applicable FDA guidelines, the FDA has 30 days to review
the BLA resubmission, determine whether it is complete and
acceptable for review, and provide the due date for action. Under
BTD and Priority Review designation, the FDA's guidance is to
complete its review within 6 months of the BLA resubmission
date.
Conference Call and Webcast Information:
Provention Bio will discuss these updates results via conference
call tomorrow, Friday, January 28,
2022 at 8:00 am ET. To access the call, please
dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international)
ten minutes prior to the start time and ask to be connected to the
"Provention Bio Call." An audio webcast will also be available on
the "Events and Webcasts" page of the Investors section of the
Company's website, www.proventionbio.com. An archived webcast
will be available on the Company's website approximately two hours
after the conference call.
About Provention Bio, Inc.:
Provention Bio, Inc.
(Nasdaq: PRVB) is a biopharmaceutical company focused on advancing
the development of investigational therapies that may intercept and
prevent debilitating and life-threatening immune-mediated disease.
The Company's pipeline includes clinical-stage product candidates
that have demonstrated in pre-clinical or clinical studies
proof-of-mechanism and/or proof-of-concept in autoimmune diseases,
including type 1 diabetes, celiac disease and lupus. Visit
www.proventionbio.com for more information and follow us on
Twitter: @ProventionBio.
Internet Posting of Information:
Provention Bio, Inc. uses its website, www.proventionbio.com,
as a means of disclosing material nonpublic information and for
complying with its disclosure obligations under Regulation F.D.
Such disclosures will be included on the Company's website in the
"News" section. Accordingly, investors should monitor this portion
of the Company's website, in addition to following its press
releases, SEC filings and public conference calls and
webcasts.
Forward-Looking Statements:
Certain statements in
this press release are forward-looking, including but not limited
to, statements relating to the medical need in T1D at-risk
patients, the potential therapeutic effects and safety of
teplizumab in at-risk T1D patients, the Company's plans to
incorporate FDA feedback into and re-file the BLA for teplizumab,
its ability to successfully address the FDA's PK comparability
considerations, the timing of the BLA resubmission and FDA's review
and teplizumab's potential approval and commercialization timeline.
These statements may be identified by the use of forward-looking
words such as "will," "believe," and "may," among others. These
forward-looking statements are based on the Company's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to FDA
disagreeing with the Company's interpretation of data and analysis;
delays in or failure to obtain FDA approvals for teplizumab or
other Company product candidates and the potential for
noncompliance with FDA regulations; any inability to successfully
work with FDA to find a satisfactory solution to address its
concerns in a timely manner or at all, including any inability to
provide the FDA with data, analysis or other information sufficient
to support an approval of the BLA for teplizumab; any inability to
satisfactorily address matters cited in the CRL including relating
to PK comparability, product quality, the safety update required by
FDA or any other FDA requirements for an approval of teplizumab;
the potential impacts of COVID-19 on our business and financial
results; changes in law, regulations, or interpretations and
enforcement of regulatory guidance; uncertainties of patent
protection and litigation; the Company's dependence upon third
parties; substantial competition; the Company's need for additional
financing and the risks listed under "Risk Factors" in the
Company's quarterly report on Form 10-Q for the quarter
ended September 30, 2021 and any subsequent filings with the
Securities and Exchange Commission. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products.
Provention does not undertake an obligation to update or revise any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by
applicable law. The information set forth herein speaks only as of
the date hereof.
Investor Contact:
Robert
Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235
Media Contact:
Lori
Rosen, LDR Communications
lori@ldrcommunications
917-553-6808
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SOURCE Provention Bio, Inc.