Biofrontera Inc. provides Update on Patient Recruitment for Phase III Study for the Treatment of sBCC with Ameluz®-PDT
02 February 2022 - 12:47AM
Biofrontera
Inc. (Nasdaq: BFRI)
(the “Company”), a biopharmaceutical company specializing in the
commercialization of dermatological products, is pleased to provide
an update on the patient recruitment for the phase III clinical
study for the treatment of superficial basal cell carcinoma (sBCC)
with Ameluz® photodynamic therapy (Ameluz®-PDT) in combination with
the BF-RhodoLED® lamp in the U.S. To date, 70% of the planned 186
patients have been enrolled in the study. Patient recruitment for
this study has been ongoing since 2018 with completion of patient
recruitment anticipated by the end of 2022.
“Due to a demanding study protocol mandated by
the FDA, the recruitment process has been taking a considerable
amount of time and was additionally slowed down by the Covid
pandemic, but has recently picked up again”, said CEO Erica Monaco.
“Following successful FDA approval, Ameluz® would be the only drug
in the United States approved for the treatment of superficial BCC
with PDT, which we expect to further increase the growth potential
of our flagship product Ameluz® in the medium term. “
This randomized, double-blind and
placebo-controlled study will include 186 patients at 12 study
sites in the United States. Each patient will have one or more
clinically and histologically confirmed superficial BCC. Patients
will receive one cycle of two PDTs 1-2 weeks apart, which may be
repeated after three months if required. The last assessment of the
patients will take place three months after the last PDT cycle.
After completion of the trial, Biofrontera will follow patients for
an additional 5-year period. Each patient will be treated with
Ameluz®-PDT or placebo-PDT. The primary study endpoint is the
composite complete clinical and histological clearance of a main
sBCC lesion, which will be selected at the beginning of the study.
In addition, data on drug safety as well as secondary efficacy
parameters of all sBCCs will be evaluated in the study.
According to the Skin Cancer Foundation, within
the total of 5.4 million annual nonmelanoma skin cancers in the US,
approximately 3.6 million skin cancer incidence are
BCCs (source:
https://www.skincancer.org/blog/our-new-approach-to-a-challenging-skin-cancer-statistic/)
This phase III clinical study, as well as two
other clinical studies currently being performed by Biofrontera AG
and its Germany-based subsidiaries (together the “Licensor”),
focuses on optimizing and expanding the market positioning of the
Company’s in-licensed FDA-approved prescription drug Ameluz® for
PDT in the United States. Within the scope of the license and
supply agreement (LSA) between Biofrontera Inc. and the Licensor,
the Company holds the exclusive rights to market and sell Ameluz®
and the PDT-lamps BF-RhodoLED® as well as the new RhodoLED® XL in
the United States. Under the terms of the LSA, Biofrontera Inc.
purchases Ameluz® from the Licensor for a transfer fee. In exchange
for the transfer fee paid for the in-licensed products, the
Licensor ensures the manufacturing and the supply of the products
as well as responsibility for certain other aspects such as
regulatory approvals and quality assurance. In addition, the LSA
calls for the Licensor to perform and finance an extensive clinical
study program to expand the FDA-approval of Ameluz® in the U.S.
market.
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,
the Company’s estimated revenue for the fourth quarter and year
ended December 31, 2021 and statements regarding the future
performance of the Company, opportunities for market growth,
objectives of management, strategic plans and future operations.
The words “believe”, “anticipate”, “intend”, “expect”, “target”,
“goal”, “estimate”, “plan”, “assume”, “may”, “will”, “predict”,
“project”, “would”, “could” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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 and its evolving nature; any changes in the Company’s
relationship with its licensors; the outcome of the Company’s
litigation with DUSA Pharmaceuticals, Inc.,; 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 RhodoLED® lamps 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 and are also available on our website at
www.biofrontera-us.com. 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
# # #
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Aug 2024 to Sep 2024
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Sep 2023 to Sep 2024