Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)
October 31 2024 - 10:32AM
Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a
biopharmaceutical company specializing in the development and
commercialization of PDT, today announced top-line results in its
Phase 3 study of the use of Ameluz® with the BF-RhodoLED® lamp in
the treatment of sBCC (study ALA-BCC-CT013).
The double-blind, randomized,
placebo-controlled, multi-center study evaluated safety and
efficacy in 187 patients with one or more clinically and
histologically confirmed superficial BCCs. They each received one
cycle of two PDT treatments (either Ameluz®-PDT or placebo-PDT) 1-2
weeks apart, repeated after three months, if required.
The primary endpoint was a composite of complete
clinical and histological clearance of one preselected “main
target” BCC lesion per patient 12 weeks after the start of the last
PDT cycle. Ameluz®-PDT achieved 65.5% success (95/145 subjects) in
this rigorous target, compared to 4.8% success (2/42 subjects)
achieved with placebo-PDT (p<0.0001). Complete histological
clearance was seen in 75.9% (110/145) of these lesions in the
Ameluz® arm, compared to 19.0% (8/42) with placebo. Complete
clinical clearance was achieved in 83.4% (121/145) of patients
treated with Ameluz® compared to 21.4% (8/42) with placebo. The
results for all other secondary efficacy parameters were equally
highly significant (p<0.0001) with, for instance, 64.1% of
Ameluz®-PDT patients achieving total clearance of all sBCC lesions
compared to only 4.8% of those treated with placebo-PDT. Most
patients who received Ameluz®-PDT rated the overall treatment
satisfaction and esthetic outcome as very good (64.3%) or good
(22.2%).”
“We are delighted that these highly significant
results mirror those found in the European studies,” stated Dr.
Hermann Luebbert, CEO and Chairman of Biofrontera. He added, “Once
we finish the one-year follow up phase in December, we will be in a
position to submit our dossier to the FDA around the end of Q2 /
early Q3 of 2025”.
“I have used Ameluz®-PDT in my practice for many
years for the treatment of Actinic Keratosis, and we were pleased
to be a part of such an extensive and rigorous study to examine its
use in patients with superficial BCC,” said Dr. David Pariser of
Virginia Clinical Research and Pariser Dermatology, and
Coordinating Investigator for the study.
“I am excited that the potential FDA approval
may provide me with a new non-invasive option for my patients that
may not involve potential scarring, or repeated office visits for
ionizing radiation, and which could therefore lead to reduced
patient burden and a beneficial cosmetic outcome,” commented Dr.
Todd Schlesinger, board certified dermatologist and Mohs surgeon,
and main contributor to the study.
About Basal Cell Carcinoma
BCC is the most common form of skin cancer and
the most frequently occurring form of all cancers. In the U.S.
alone, an estimated 3.6 million cases are diagnosed each year, a
subset of which is superficial basal cell carcinoma. BCCs arise
from abnormal, uncontrolled growth of basal cells at the bottom of
the epidermis. They rarely spread beyond the original tumor
site but, if untreated, can become locally invasive, grow wide and
deep into the skin, and destroy skin, tissue and bone.1
1
https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
About Biofrontera Inc.
Biofrontera is a U.S.-based biopharmaceutical
company specializing in the treatment of dermatological conditions
with a focus on PDT. The Company commercializes the drug-device
combination Ameluz® with the RhodoLED® lamp series for PDT of
Actinic Keratosis, pre-cancerous skin lesions which may progress to
invasive skin cancers2. The Company performs clinical trials to
extend the use of the products to treat non-melanoma skin cancers
and moderate to severe acne. For more information,
visit www.biofrontera-us.com and follow Biofrontera
on LinkedIn and X.
2
https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
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. These statements include, but are not limited to,
statements relating to Biofrontera's commercial opportunities and
the commercial success of its licensed products. 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, include, but are not limited to: the impact
of any extraordinary external events; 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 and/or RhodoLED XL 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 and/or RhodoLED XL is consistent with
the Company’s expectations; 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 Securities and Exchange Commission
(the “SEC”), which can be obtained on the SEC’s 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.
Contact:Investor
RelationsAndrew Barwicki1-516-662-9461ir@bfri.com
Biofrontera (NASDAQ:BFRI)
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