AN2 Therapeutics Provides Update on EBO-301 Phase 2/3 Study Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium Complex (MAC) Lung Disease
08 Agosto 2024 - 3:30PM
Business Wire
EBO-301 study to be discontinued following
topline results from Phase 2 part of the study in
treatment-refractory patients with MAC lung disease
AN2 plans to shift focus to internal boron
chemistry platform and ongoing pipeline programs
Company restructuring and cost savings
associated with discontinuation of the EBO-301 study expected to
extend cash runway through 2027
AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical
company focused on discovering and developing novel small molecule
therapeutics derived from its boron chemistry platform today
announced topline results from the Phase 2 part of the EBO-301
Phase 2/3 study evaluating epetraborole on top of an optimized
background regimen (OBR) in treatment-refractory MAC lung
disease.
The Phase 2 part of the study met its primary objective of
demonstrating the potential validation of a novel patient-reported
outcome (PRO) tool and a higher PRO-based clinical response rate in
the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%;
treatment difference 13.9%, p=0.19). However, sputum culture
conversion at Month 6, a key secondary endpoint, was similar
between treatment arms (13.2% in epetraborole + OBR vs. 10.0%
placebo + OBR; treatment difference 3.4%, p=0.64).
In February, the Company voluntarily paused new patient
enrollment in the Phase 3 part of the study due to potentially
lower-than-expected efficacy observed in blinded aggregate data.
Based on the topline data announced today, the Company will
terminate the Phase 2 (80 patients) and Phase 3 parts of the
EBO-301 trial (97 patients enrolled prior to pause). Oral
epetraborole 500 mg daily was generally well-tolerated and the
study was not terminated due to safety concerns.
“These results are deeply disappointing as there is a high unmet
need for new therapies in treatment-refractory MAC lung disease,”
said Eric Easom, Co-founder, Chairman, President and CEO. “We
sincerely thank the patients, investigators, study site staff and
AN2 employees who were part of the journey to investigate the
prospects of epetraborole in this very difficult-to-treat patient
population.”
“In the coming months, we will further evaluate the results from
the EBO-301 study and make informed decisions regarding potential
future development of epetraborole for NTM lung disease in other
patient populations. In the near-term, we plan to accelerate our
R&D efforts on our boron chemistry platform where we believe we
have several promising programs in infectious diseases and
oncology. We plan to embark on a strategic restructuring and expect
to extend our cash runway through 2027, focusing our cash resources
on advancing our pipeline through multiple milestones,” said
Easom.
AN2’s core technology approach is based on the use of boron
chemistry for its research and development initiatives. Boron has a
distinctive ability to bind with biological targets through a
reversible covalent bond and the potential to address biological
targets that have been difficult to inhibit using traditional
carbon-based molecules.
Pipeline Programs/ Milestones
- Chagas Disease: The Company plans to initiate Phase 1
clinical development of its product candidate aimed to cure chronic
Chagas disease, a disease that affects an estimated 6-7 million
people worldwide including approximately 300,000 in the U.S. and
causes severe cardiac disease and death.
- Melioidosis: The Company plans to initiate a Phase 2
study with epetraborole in melioidosis, a deadly bacterial
infection and global bioterrorism threat, with a goal of
significantly reducing the 3-month mortality rate of ~50%.
- Early-Stage Pipeline: Additional research programs are
underway and focused on targets in infectious diseases and oncology
with high unmet needs. The Company anticipates multiple development
compounds within its cash runway.
- Global Health: The Company will continue its efforts to
tackle global health disease areas through non-dilutive funding,
including tuberculosis and malaria, funded by the Gates
Foundation.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a biopharmaceutical company focused on
discovering and developing novel small molecule therapeutics
derived from its boron chemistry platform. AN2 has a pipeline of
boron-based compounds in development for Chagas disease, NTM, and
melioidosis, along with early-stage programs focused on targets in
infectious diseases and oncology. For more information, please
visit our website at www.an2therapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements expressed or implied in this press
release include, but are not limited to, statements regarding: the
Company’s plans to shift its focus to its internal boron chemistry
platform and ongoing pipeline programs; strategic restructuring;
cash runway; further evaluation of the results from the EBO-301
study and any future development of epetraborole for NTM lung
disease; acceleration of R&D efforts on the Company’s boron
chemistry platform; potential for the identification of development
compounds in infectious disease or oncology; and other statements
that are not historical fact. These statements are based on AN2’s
current estimates, expectations, plans, objectives, and intentions,
are not guarantees of future performance, and inherently involve
significant risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, but are not limited to, risks and
uncertainties related to: potential disruptions related to AN2’s
restructuring plans and its ability to implement its plans for its
internal boron chemistry platform and ongoing pipeline programs;
timely enrollment of patients in AN2’s existing and future clinical
trials; AN2’s ability to procure sufficient supply of its product
candidates for its existing and future clinical trials; the
potential for results from clinical trials to differ from
preclinical, early clinical, preliminary or expected results;
significant adverse events, toxicities or other undesirable side
effects associated with AN2’s product candidates; the significant
uncertainty associated with AN2’s product candidates ever receiving
any regulatory approvals; continued funding by the National
Institute of Allergy and Infectious Disease (NIAID) of the
Company’s development program for melioidosis; AN2’s ability to
obtain, maintain, or protect intellectual property rights related
to its current and future product candidates; implementation of
AN2’s strategic plans for its business and product candidates; the
sufficiency of AN2’s capital resources and need for additional
capital to achieve its goals; global macroeconomic conditions and
global conflicts; and other risks, including those described under
the heading “Risk Factors” in AN2’s reports filed with the U.S.
Securities and Exchange Commission (SEC), including AN2’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2024. These
filings, when made, are available on the investor relations section
of AN2’s website at investor.an2therapeutics.com and on the SEC’s
website at www.sec.gov. Forward-looking statements contained in
this press release are made as of this date, and AN2 undertakes no
duty to update such information except as required under applicable
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240808125351/en/
Lucy O. Day Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge Investor Relations
abowdidge@an2therapeutics.com
AN2 Therapeutics (NASDAQ:ANTX)
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