Biofrontera Inc. Announces Enrollment of First Subject in Phase 2b Clinical Trial Evaluating Ameluz® + BF-RhodoLED® in Moderate-to-Severe Acne
December 13 2021 - 9:09AM
Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today that the first subject
has been enrolled in the Phase 2b study performed by Biofrontera
Bioscience GmbH to evaluate the safety and efficacy of Ameluz® in
combination with the red-light lamp BF-RhodoLED® for the treatment
of moderate-to-severe acne with photodynamic therapy (Ameluz®-PDT).
“Ameluz®-PDT has the potential to improve
treatment outcomes for millions of Americans with
moderate-to-severe acne. This study is an important component of
Biofrontera group’s clinical development strategy that aims to
expand the FDA-label of our licensed product Ameluz®. The inclusion
of additional indications aims at unlocking its full therapeutic
and market potential in the US,” stated Erica Monaco, Chief
Executive Officer of Biofrontera Inc.
The multicenter, randomized, double blind phase
II study with four arms uses conventional Ameluz®-PDT and includes
126 adult patients suffering from moderate to severe acne, which
will be treated with Ameluz®-PDT or placebo. The efficacy of
Ameluz®-PDT will be tested with respect to incubation periods of
one and three hours compared to placebo. The composite primary
endpoint of the study is the absolute change in the number of
inflammatory lesions and an improvement in symptoms. To ensure data
consistency across all participating sites, the study will combine
clinical assessments performed by the investigators conducting the
study with a cutting-edge, FDA-approved, artificial intelligence
analysis platform that will provide an automated lesion count along
with a severity assessment. A total of seven sites are
participating in the study.
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based
biopharmaceutical company commercializing a portfolio of
pharmaceutical products for the treatment of dermatological
conditions with a focus on photodynamic therapy (PDT) and topical
antibiotics. The Company’s licensed products are used for the
treatment of actinic keratoses, which are pre-cancerous skin
lesions, as well as impetigo, a bacterial skin infection. For more
information, visit www.biofrontera-us.com.
Forward-Looking Statements
Certain statements in this press release may
constitute "forward-looking statements" within the meaning of the
United States Private Securities Litigation Reform Act of 1995, as
amended to date. These statements include, but are not limited to,
statements relating to the expected trading commencement and
closing dates. We have based these forward-looking statements on
our current expectations and projections about future events,
nevertheless, actual results or events could differ materially from
the plans, intentions and expectations disclosed in, or implied by,
the forward-looking statements we make. These risks and
uncertainties, many of which are beyond our control, including, but
not limited to, the impact of extraordinary external events, such
as the current COVID-19 pandemic; any changes in the Company’s
relationship with the Licensor; the outcome of the Company’s
litigation with DUSA Pharmaceuticals, Inc., including the trial
scheduled to begin at the end of November; the Company’s ability to
achieve and sustain profitability; whether the current disruptions
in the supply chain will impact the Company’s ability to obtain and
distribute its licensed products; changes in the practices of
healthcare providers, including any changes to the coverage,
reimbursement and pricing for procedures using the Company’s
licensed products; the uncertainties inherent in the initiation and
conduct of clinical trials; availability and timing of data from
clinical trials; whether results of early clinical trials or trials
in different disease indications will be indicative of the results
of ongoing or future trials; whether results of the studies
described above will be indicative of results for any future
clinical trials and studies of Ameluz® in combination with
BF-RhodoLED®; uncertainties associated with regulatory review of
clinical trials and applications for marketing approvals; whether
the market opportunity for Ameluz® in combination with BF-RhodoLED®
is consistent with the Company’s expectations; whether the Company
will be able to successfully transition to a public company
operating independently of Biofrontera AG; the Company’s ability to
retain and hire key personnel; the sufficiency of cash resources
and need for additional financing and other factors that may be
disclosed in the Company’s filings with the SEC, which can be
obtained on the SEC website at www.sec.gov. Readers are cautioned
not to place undue reliance on the forward-looking statements,
which speak only as of the date on which they are made and reflect
management's current estimates, projections, expectations and
beliefs. The company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law.
Contacts
Biofrontera Inc.Pamela Keck+1
781 486 1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
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