Biofrontera Inc. Enrolls First Subject in Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz®
December 06 2021 - 9:00AM
Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today that the first subject
has been enrolled in a Phase 1 study to evaluate the safety and
tolerability of photodynamic therapy (PDT) for the treatment of
actinic keratosis (AK) using three tubes of Ameluz® together with
the company’s BF-RhodoLED® XL lamp. This open-label study is being
conducted at eight sites and will enroll 100 subjects with
mild-to-severe AK on the face and scalp.
“Today’s news marks an important step in our
clinical program for optimizing the positioning of our flagship
product Ameluz®," commented Erica Monaco, Chief Executive Officer
of Biofrontera Inc. "The use of three tubes of Ameluz® enables
treatment of larger surface areas such as for mild-to-severe AK on
the face and scalp. Success with this study could significantly
improve the competitiveness of Ameluz® in the U.S. and advance
Biofrontera’s goal of gaining market share for PDT as standard of
care for treatment of AK.”
The Phase 1 study follows a maximal-usage
pharmacokinetics (PK) clinical study that was completed in early
2021. As announced in June, results from that PK study were
presented to the U.S. Food and Drug Administration (FDA). The FDA
subsequently requested another safety study focusing on transient
adverse events before amending the product information, which
currently limits use to one tube of Ameluz® per treatment.
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 the fields of photodynamic therapy
(PDT) and topical antibiotics, Biofrontera currently commercializes
the FDA-approved flagship drug Ameluz® in the United States. When
used in combination with PDT and Biofrontera’s BF-RhodoLED® lamp,
Ameluz®-PDT is indicated for the treatment of actinic keratoses
(AK), one of the most common precancerous skin conditions.
Biofrontera also commercializes Xepi®, an FDA-approved drug for the
treatment of impetigo. In collaboration with dermatologists,
Biofrontera is fully committed to advancing treatment options and
patient care. 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
Patel+1 212 201 6614tpatel@lhai.com
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