Basilea announces acquisition of novel clinical-stage antifungal for treatment of Aspergillus mold infections
19 Outubro 2023 - 2:15AM
Basilea announces acquisition of novel clinical-stage antifungal
for treatment of Aspergillus mold infections
- New compound added to
Basilea’s clinical pipeline; upon successful completion of
preclinical profiling, start of phase 2 study planned for H1
2025
- Upfront payments of USD 2
million
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, October 19, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
announced today that it has entered into an asset purchase
agreement with privately owned Gravitas Therapeutics Inc. for
GR-2397, a clinical-stage antifungal compound with a novel
mechanism of action, targeting invasive mold infections caused by
Aspergillus species.
David Veitch, Chief Executive Officer of Basilea, stated: “This
is the first transaction in the implementation of our strategy to
expand our clinical-stage anti-infectives pipeline and to
complement our portfolio of marketed products, Cresemba and
Zevtera. We are looking forward to developing this asset.”
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, added:
“With GR-2397, now referred to as BAL2062, we are adding an
antifungal compound to our pipeline that has already completed a
clinical phase 1 study. Based on its novel mechanism of action
which results in rapid fungicidal activity in vitro, BAL2062 could
become a valuable treatment option against difficult-to-treat
invasive mold infections. To define the optimal positioning and the
most efficient clinical development path, we will initiate a
focused preclinical profiling program. Upon successful completion
of the preclinical profiling, we are planning to move directly into
phase 2 clinical development in the first half of 2025.”
BAL2062 (formerly GR-2397) is a first-in-class antifungal,
derived from a natural product, and has demonstrated fungicidal
activity against clinically important molds such as Aspergillus
spp., including azole-resistant strains.1 Safety and tolerability
have been demonstrated in a previously completed phase 1 study with
single and multiple ascending intravenous (i.v.) doses.2 The drug
candidate has Qualified Infectious Disease Product (QIDP), Orphan
Drug and Fast Track designation from the US Food & Drug
Administration (FDA) for invasive aspergillosis.
Basilea is paying USD 2 million in upfront payments. Under the
asset purchase agreement with Gravitas, Basilea assumes the rights
and obligations under a license agreement with Astellas Pharma Inc.
who owns patents relating to BAL2062 (formerly GR-2397) and takes
over an agreement with Fresh Tracks Therapeutics Inc., who
previously owned the asset that was acquired by Gravitas. Upon
achievement of defined milestones, Basilea will make total
pre-approval milestone payments of up to USD 1.75 million and up to
USD 67 million in total approval and commercialization milestone
payments. In addition, Basilea will pay tiered royalties on sales
starting in the low single-digit percentage range, going to the
mid-single-digit percentage range.
About invasive aspergillosis
Invasive aspergillosis is a life-threatening mold infection that
predominantly affects immunocompromised patients, such as patients
with hematologic malignancies (blood cancer). The infection is
associated with high morbidity and mortality.
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded
in 2000 and headquartered in Switzerland. We are committed to
discovering, developing and commercializing innovative drugs to
meet the needs of patients with severe bacterial and fungal
infections. We have successfully launched two hospital brands,
Cresemba for the treatment of invasive fungal infections and
Zevtera for the treatment of bacterial infections. In addition, we
have an R&D portfolio of anti-infective assets. Basilea is
listed on the SIX Swiss Exchange (SIX: BSLN). Please visit
basilea.com.
Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements, such as "believe", "assume", "expect",
"forecast", "project", "may", "could", "might", "will" or similar
expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its
business, including with respect to the progress, timing and
completion of research, development and clinical studies for
product candidates. Such statements involve certain known and
unknown risks, uncertainties and other factors, which could cause
the actual results, financial condition, performance or
achievements of Basilea Pharmaceutica Ltd, Allschwil to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Basilea Pharmaceutica Ltd, Allschwil is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new
information, future events or otherwise.
For further information, please contact:
Peer Nils Schröder, PhD Head of Corporate
Communications & Investor RelationsBasilea Pharmaceutica
International Ltd, Allschwil Hegenheimermattweg 167b4123
AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.cominvestor_relations@basilea.com |
This ad hoc announcement can be downloaded from
www.basilea.com.
References
- K. J. Shaw. GR-2397: Review of the Novel
Siderophore-like Antifungal Agent for the Treatment of Invasive
Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909
- ClinicalTrials.gov identifier NCT02956499:
M. P. Mammen, D. Armas, F. H. Hughes et
al. First-in-Human Phase 1 Study To Assess Safety, Tolerability,
and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in
Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63),
e00969-19
Press release (PDF)
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