RED BANK, N.J., Sept. 13, 2021 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today provided
an update on the status and timing of its ongoing efforts to
address FDA considerations cited in the Complete Response Letter
(CRL) issued to the Company by the FDA on July 2, 2021.
The Company has completed the collection of data from a PK/PD
substudy in the ongoing PROTECT Phase 3 trial in newly diagnosed
T1D patients (AGC Biologics N~30 patients, Eli Lilly N~130
patients) to determine comparability between the Company's planned
commercial drug product and drug product originating from drug
substance manufactured for historical trials of teplizumab.
During ongoing informal discussions with the FDA to finalize and
agree upon the design of the population PK model that will generate
the PK parameters comparing drug products, the FDA has recommended
that the Company request a formal Type A meeting and submit
briefing documents related to the population PK model. The
objective of this meeting with the FDA is to agree on the PK
model's design prior to the Company populating the model with
relevant PK data collected from the PROTECT substudy. The
Company is working towards a request and submission to allow this
Type A meeting to occur in the fourth quarter of this year.
Additionally, the Company disclosed preliminary PD marker
information upon therapeutic dosing of teplizumab from the substudy
data that the Company believes are supportive, although not
determinative, of comparability between the two drug products. The
FDA has not yet opined on these data or their significance, and the
Company looks forward to discussing with the FDA. These PD
markers include lymphocyte counts, CD3 receptor occupancy and
T-cell activation.
The Company also recently completed a Type A meeting with the
FDA to discuss several additional considerations related to product
quality that were cited in the CRL. The Company continues to
believe that the product quality CRL considerations have either
already been addressed by prior amendments to the BLA or are
addressable in the short term. As it relates to the
deficiencies noted during the recent general inspection at a
fill/finish facility used by the Company mentioned in the CRL, this
facility's inspection has since been closed out by the FDA in
August of 2021.
The Company has posted an update to its corporate slide
presentation containing additional details pertaining to the
information commented on within this press release. The
presentation can be found at www.proventionbio.com in the
Investor's section.
"We believe we are making significant progress in our work to
address the observations cited by the FDA in the CRL for teplizumab
we received in July and we will continue to work with the sense of
urgency that the patient community and our investors expect of us,"
said Ashleigh Palmer, co-founder and
CEO of Provention Bio. "We are encouraged by our interactions with
the FDA and look forward to finalizing, to the FDA's satisfaction,
the design of the population PK model that will be used to further
determine comparability, as well as evaluate the clinical relevance
of the outputs. Additionally we are encouraged by the
consistent incremental PD marker data that we are sharing
today."
The Unmet Need in Type 1 Diabetes (T1D):
Over 1.6 million Americans have T1D, an autoimmune disease
caused by the destruction of beta cells. Diagnosis of T1D usually
occurs in children and young adults, but it can happen at any age
after symptoms appear when a person cannot make enough insulin.
However, T1D starts in the body long before any symptoms and can be
detected through a blood test. The psychological impact of T1D is
hard to quantify, but a diagnosis is life-altering, and regular
monitoring and maintenance can be extremely stressful. T1D
typically takes more than a decade off a person's life, and life
expectancy is reduced by 16 years on average for people diagnosed
before the age of 10. Insulin therapy and glucose monitoring are
currently the standard of care for treating clinical-stage T1D, and
are necessary to keep T1D patients alive. The constant monitoring
and administration of insulin represents a significant life-long
burden for patients. No disease-modifying treatments for T1D are
currently available.
About Teplizumab (PRV-031):
Teplizumab is an investigational anti-CD3 monoclonal antibody
(mAb) being developed for the delay of clinical type 1 diabetes
(T1D) in at-risk individuals. In the pivotal TN-10 Study, a single
14-day course of teplizumab delayed insulin-dependent,
clinical-stage disease by a median of at least two years in
presymptomatic patients with Stage 2 T1D compared to placebo. The
observed adverse events were mechanism-based, transient, and
predictable, including lymphopenia, transaminase elevations, rash,
and cytokine release events. These results were published in
the New England Journal of Medicine and simultaneously
presented at the American Diabetes Association meeting in 2019.
More than 800 patients have received teplizumab in multiple
clinical studies involving more than 1,000 subjects. In previous
studies of newly diagnosed patients, teplizumab consistently
demonstrated the ability to preserve beta-cell function as shown by
C-peptide, a measure of endogenous insulin production. It
correspondingly reduced the need for insulin use. Teplizumab has
been granted Breakthrough Therapy Designation by the FDA and PRIME
designation by the European Medicines Administration. Provention is
currently also evaluating teplizumab in patients with newly
diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).
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 potential for
PK/PD substudy data and analyses to address the FDA's PK
comparability considerations, the Company's belief that the
remaining product quality issues cited in the CRL are addressed or
may be adressable in the short-term, the timing of the FDA's review
of such data and analyses if submitted by the Company and the
Company's plans to address the other matters raised in the CRL.
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,
including the preliminiary PD data referenced in this release which
could change as these data are finalized; 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 PK/PD data
from our ongoing Phase 3 PROTECT study or other data sufficient to
support an approval of the BLA for teplizumab; an inability to
satisfactorily address other matters cited in the CRL including
relating to 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 June 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 Contacts:
Robert Doody, VP of Investor
Relations
rdoody@proventionbio.com
484-639-7235
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media Contact:
Lori Rosen, LDR
Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.