Biofrontera to Launch Phase 3 Clinical Study Evaluating Ameluz®-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk
22 November 2022 - 12:48AM
Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today the launch of a
randomized, double-blind, vehicle-controlled, multicenter Phase 3
clinical study to evaluate the safety and efficacy of Ameluz® and
BF-RhodoLED® XL in the field-directed treatment of actinic
keratosis (AK) on the extremities, neck and trunk. The study is
being managed by Biofrontera Bioscience GmbH.
This past weekend Biofrontera held an
Investigator Meeting to train clinical investigators on the
protocol for this photodynamic therapy (PDT) study and prepare for
site initiation. Initially 11 clinical trial sites in the U.S. will
participate, enrolling approximately 165 patients stratified by
body region. This study will utilize Biofrontera’s new RhodoLED®
XL, a red-light lamp approved by the U.S. Food and Drug
Administration (FDA) for use in PDT in combination with Ameluz®
(Ameluz®-PDT) for the treatment of mild-to-moderate actinic
keratosis. This lamp allows for the illumination of a larger
surface area, thereby enabling simultaneous treatment of AK lesions
that are distant from one another.
“This Phase 3 clinical study supports our
strategy to gain market share by expanding the label for
Ameluz®-PDT beyond the treatment of AK on the face and scalp.
Additionally, by employing the larger RhodoLED® XL lamp
investigators can target more lesions and reinforce the lamp’s
utility ahead of commercial launch,” said Erica Monaco, Chief
Executive Officer of Biofrontera Inc.
Patients enrolled in this study will have 4-15
mild-to-moderate AK lesions in the treatment field. Each will be
treated once with Ameluz®-PDT and upon a three-month evaluation,
will be treated a second time if any lesions remain. Investigators
will continue to follow patients for 12 months after their most
recent treatment to monitor for any recurrences or new lesions, as
well as for any adverse events. The primary endpoint is total
clearance of all lesions three months after the most recent
treatment. Secondary endpoints are total clearance of all lesions
three months after the last treatment by body region, percentage of
all lesions cleared overall and percentage cleared by body region
and severity.
Ameluz® and the BF-RhodoLED® lamps, through
Biofrontera Inc.’s license and supply agreement with Biofrontera
AG, are also undergoing clinical testing in three additional
indications:
- A Phase 3 clinical study in the
U.S. evaluating Ameluz®-PDT utilizing the BF-RhodoLED® lamp for the
treatment of superficial basal cell carcinoma.
- A multicenter, randomized,
double-blind Phase 2 clinical study evaluating the efficacy of
Ameluz®-PDT for the treatment of moderate-to-severe acne.
- An open-label, multicenter Phase 1
clinical study evaluating the safety and tolerability of Ameluz-PDT
for the treatment of AK located on the face and scalp utilizing the
BF-RhodoLED® XL lamp and three tubes of Ameluz®.
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 Biofrontera Inc.’s (the “Company”)
revenue guidance for 2022, the Company’s relationship with
Biofrontera AG (including beneficial ownership of Biofrontera AG’s
shares and future collaboration between the Company and Biofrontera
AG), business and marketing strategy, hiring strategy, development
of medical affairs initiatives, growth of the Company’s profile,
future operations and business, increased patent protection for our
licensed products, potential to expand the label of Ameluz® ,
market presence and position of Ameluz® and ongoing clinical
trials conducted by our licensing partners and the future impact of
such trials on the market for Ameluz®. 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 its
licensors; the ability of the Company’s licensors to fulfill their
obligations to the Company in a timely manner; the Company’s
ability to achieve and sustain profitability; whether the current
global disruptions in supply chains 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 earlier clinical
trials or trials of Ameluz® in combination with BF-RhodoLED®
in different disease indications or product applications will be
indicative of the results of ongoing or future trials;
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; the Company’s ability
to complete the transition to a public company; 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.Anke zur
Mühlen+1 781 486 1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
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