- U.S. Food and Drug Administration (FDA) provides feedback
necessary to proceed into a phase 2 proof of concept (PoC)/dose
ranging study of cudetaxestat in patients with idiopathic pulmonary
fibrosis (IPF)
- Company plans to advance cudetaxestat, a non-competitive
inhibitor of autotaxin, into a 26-week phase 2 clinical trial in
the second quarter of 2022
Blade Therapeutics, Inc. (“Blade” or
“Company”), a biopharmaceutical company focused on developing
cutting-edge treatments for debilitating fibrotic and
neurodegenerative diseases, today announced receipt of feedback
from the FDA regarding the company’s end-of-phase 1 data package
for cudetaxestat, an investigational non-competitive autotaxin
inhibitor in clinical development for treatment of IPF and other
fibrotic diseases. The FDA response letter outlined requirements
for a proposed phase 2 PoC/dose ranging study for use of
cudetaxestat in patients with IPF. Based on the FDA feedback, Blade
plans to advance cudetaxestat into a 26-week global phase 2 trial
in patients with IPF in the second quarter of 2022, pending
completion of preclinical toxicology studies.
“We are pleased with the guidance provided by the FDA,” said
Wendye Robbins, M.D., president and CEO of Blade. “Taking a
stepwise approach through multiple phase 1 trials provided
significant new knowledge and confidence in the safety profile of
cudetaxestat. We are now ready to advance cudetaxestat into a phase
2 clinical study that reflects the clinical treatment needs of
patients with IPF.”
The randomized, double-blinded, placebo-controlled phase 2 trial
will evaluate the safety and efficacy of cudetaxestat (250mg once
daily, 500mg once daily, and 500mg twice daily) dosed as
monotherapy or co-administered with an approved IPF therapy
(pirfenidone or nintedanib) in patients with IPF. The primary study
endpoint is change from baseline to week 26 in forced vital
capacity lung volume measured in milliliters (mL) and assessed by
clinic spirometry throughout the study duration. A blinded interim
analysis will be conducted at 13 weeks after completion of
enrollment to assess biomarkers (lysophosphatidic acid target
engagement, PRO-C3, and PRO-C6). The study is expected to enroll
approximately 200 patients across approximately 90 sites in the
United States, Europe, and Asia-Pacific.
Cudetaxestat
Cudetaxestat (BLD-0409), a non-competitive, reversible inhibitor
of autotaxin, has demonstrated direct anti-fibrotic activity and
differentiating preclinical and biochemical characteristics which
support the potential for a treatment profile in lung and liver
fibrosis. Available data from completed phase 1 studies in healthy
volunteers showed that cudetaxestat was well tolerated with a
demonstrated pharmacokinetic/pharmacodynamic correlation and
biomarker activity. Cudetaxestat has been granted orphan drug
designations in the treatment of IPF and systemic sclerosis.
Cudetaxestat is an investigational medicine that is not approved
for commercial use by the FDA or any other regulatory
authority.
Autotaxin
Pro-fibrotic processes are stimulated by autotaxin, a key enzyme
responsible for generating the potent signaling lipid
lysophosphatidic acid (LPA). Excessive autotaxin levels and
activity play a central role in various fibrotic diseases and occur
in response to epithelial cell/tissue damage, leading to elevated
levels of LPA. LPA binds to LPA receptors on myofibroblasts,
thereby triggering a signaling cascade that leads to myofibroblast
activation/differentiation. Activated myofibroblasts produce
extracellular matrix proteins that make up the fibrotic lesion
(organ/tissue scarring). Increased autotaxin levels and activity
are associated with liver, lung, kidney, and skin fibrosis. In
addition, autotaxin levels correlate with fibrosis severity in
various liver diseases (e.g., nonalcoholic fatty liver
disease/nonalcoholic steatohepatitis (NASH)). Inhibition of the
autotaxin pathway has been clinically validated in IPF.
Fibrosis
Fibrosis is a complex, pathologic process involving the
development of organ/tissue scarring characterized by deposition of
extracellular matrix proteins that develop in response to aberrant
cell/tissue damage. Excessive fibrosis disrupts normal architecture
and function of organs/tissues. Later-stage fibrotic disease is
marked by poor outcomes and high morbidity and mortality. Diseases
characterized by uncontrolled, progressive fibrosis include IPF,
interstitial lung disease, and NASH. New well-tolerated therapies
that provide robust attenuation of disease progression are needed
to address the high burden of fibrotic diseases.
About Blade Therapeutics
Blade Therapeutics, Inc. is a biopharmaceutical company focused
on developing cutting-edge treatments for debilitating, incurable
fibrotic and neurodegenerative diseases that impact millions of
people worldwide. The company has deep expertise in novel
biological pathways – including autotaxin / LPA and calpain biology
– that are foundational to cell- and tissue-damage responses
resulting from protein deposition or aggregation associated with
fibrotic and neurodegenerative diseases. Blade expects to advance a
differentiated pipeline of oral, small-molecule therapies that
include a non-competitive autotaxin inhibitor and inhibitors of
dimeric calpains designed for potential treatment of lung, liver
and cardiac fibrosis or neurodegenerative diseases. The company’s
focused approach offers the potential to produce disease-modifying,
life-saving therapies. Visit www.blademed.com for more information
and follow Blade on LinkedIn.
On November 8, 2021, Biotech Acquisition Company (NASDAQ: BIOT),
a special purpose acquisition company affiliated with SPRIM Global
Investments, and Blade announced (click here) that they have
entered into a definitive merger agreement. Upon the closing of the
transaction, the combined company will be renamed Blade
Biotherapeutics, Inc., and is expected to be listed on Nasdaq under
the symbol “BBTX.” PIPE financing is anchored by leading
institutional investors, including Deerfield Management, Pfizer
Ventures, Bristol Myers Squibb, MPM Capital and Osage University
Partners.
About Biotech Acquisition Company
Biotech Acquisition Company raised $230 million in its initial
public offering in January 2021. The Class A ordinary shares and
warrants of BAC trade on the Nasdaq Capital Market under the
symbols “BIOT” and “BIOTW,” respectively. BAC is a blank check
company, incorporated as a Cayman Islands exempted company, formed
for the purpose of effecting a merger, amalgamation, share
exchange, asset acquisition, share purchase, reorganization or
other similar business combination with one or more businesses. BAC
believes that a business combination with a company focused on the
healthcare sector will complement the background and expertise of
SPRIM Global Investments, a global investment firm in the life
sciences and healthcare industries, which is an affiliate of BAC
and of several members of the management team behind BAC. BAC is
led by Dr. Michael Shleifer, its CEO and chairman.
Important Information and Where to Find It
This press release relates to a proposed merger between Blade
and BAC. This press release does not constitute an offer to sell or
exchange, or the solicitation of an offer to buy or exchange, any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. BAC has filed a
registration statement on Form S-4 with the SEC, which includes a
proxy statement/prospectus, to be used at the meeting of its
shareholders to approve the proposed merger between Blade and BAC
and related matters. Promptly after the registration statement is
declared effective by the SEC, BAC will mail the definitive proxy
statement/prospectus and a proxy card to each shareholder of BAC as
of a record date for the meeting of BAC shareholders to be
established for voting on the proposed business combination.
Investors and security holders of BAC are urged to read these
materials (including any amendments or supplements thereto) and any
other relevant documents in connection with the transaction that
BAC has filed or will file with the SEC when they become available
because they will contain important information about BAC, Blade,
and the transaction. The preliminary proxy statement/prospectus,
the definitive proxy statement/prospectus and other relevant
materials in connection with the transaction (when they become
available), and any other documents filed by BAC with the SEC, may
be obtained free of charge at the SEC’s website (www.sec.gov). The
documents filed by BAC with the SEC also may be obtained free of
charge upon written request to Biotech Acquisition Company, 545
West 25th Street, 20th Floor, New York, NY 10001.
Participants in the Solicitation
BAC and its directors and executive officers may be deemed
participants in the solicitation of proxies from BAC’s shareholders
with respect to the business combination and related matters.
Information about BAC’s directors and executive officers and a
description of their interests in BAC and the proposed transaction
will be included in the proxy statement/prospectus for the proposed
transaction when available and will be available free of charge at
the SEC’s website (www.sec.gov).
Blade and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
shareholders of BAC in connection with the proposed business
combination and related transactions. Information about Blade’s
directors and executive officers and information regarding their
interests in the proposed transaction will be included in the proxy
statement/prospectus for the proposed transaction when available
and can be obtained free of charge as described in the preceding
paragraph.
No Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the potential transaction and shall not constitute an
offer to sell or a solicitation of an offer to buy, or a
recommendation to purchase any securities of BAC (the combined
company) or Blade, nor shall there be any sale of any such
securities, investments or other specific product in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
Special Note Regarding Forward-Looking Statements
Certain statements included in this press release that are not
historical facts but rather are forward-looking statements.
Forward-looking statements generally are accompanied by words such
as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “should,” “would,” “plan,” “future,” “outlook,”
and similar expressions that predict or indicate future events or
trends or that are not statements of historical matters, but the
absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements include, but are
not limited to, statements regarding estimates and forecasts of
other performance metrics and projections of market opportunity.
These statements are based on various assumptions, whether or not
identified in this press release, and on the current expectations
of BAC’s and Target’s respective management and are not predictions
of actual performance. These forward-looking statements are
provided for illustrative purposes only and are not intended to
serve as, and must not be relied on by any investor as, a
guarantee, an assurance, a prediction or a definitive statement of
fact or probability. Actual events and circumstances are difficult
or impossible to predict and will differ from assumptions. Many
actual events and circumstances are beyond the control of BAC and
the Target. Some important factors that could cause actual results
to differ materially from those in any forward-looking statements
could include changes in domestic and foreign business, market,
financial, political and legal conditions. These forward-looking
statements are subject to a number of risks and uncertainties,
including, the inability of the parties to successfully or timely
consummate the Transaction, including the risk that any required
regulatory approvals are not obtained, are delayed or are subject
to unanticipated conditions that could adversely affect the
Combined Entity or the expected benefits of the Transaction, if not
obtained; the failure to realize the anticipated benefits of the
Transaction; matters discovered by the parties as they complete
their respective due diligence investigation of the other parties;
the ability of BAC prior to the Business Combination, and the
Combined Entity following the Business Combination, to maintain the
listing of the Company’s shares on Nasdaq; costs related to the
Transaction; future financial performance of the Company following
the Business Combination; the ability of the Company to forecast
and maintain an adequate rate of revenue growth and appropriately
plan its expenses; expectations regarding future expenditures of
the Company following the Business Combination; the future mix of
revenue and effect on gross margins of the Company following the
Business Combination; the Company’s ability to execute its business
plans and strategy; the failure to satisfy the conditions to the
consummation of the Transaction, including the approval of the
definitive merger agreement by the shareholders of BAC, the
satisfaction of the minimum cash requirements of the definitive
merger agreement following any redemptions by BAC’s public
shareholders; the risk that the Transaction may not be completed by
the stated deadline and the potential failure to obtain an
extension of the stated deadline; the inability to complete a PIPE
transaction; the outcome of any legal proceedings that may be
instituted against BAC or the Target related to the Transaction;
the attraction and retention of qualified directors, officers,
employees and key personnel of BAC and the Target prior to the
Business Combination, and the Company following the Business
Combination; the ability of the Company to compete effectively in a
highly competitive market; neither BAC nor the Target are currently
generating revenues and there can be no assurance that following
the Business Combination, the Company will ever achieve revenues or
profitability; the ability to protect and enhance the Target’s
respective corporate reputation and brand; the impact from future
regulatory, judicial, and legislative changes in the Target’s or
the Company’s industry; the timing, costs, conduct, and outcome of
clinical trials and future preclinical studies and clinical trials,
including the timing of the initiation and availability of data
from such trials; the timing and likelihood of regulatory filings
and approvals for product candidates; whether regulatory
authorities determine that additional trials or data are necessary
in order to obtain approval; the potential market size and the size
of the patient populations for product candidates, if approved for
commercial use, and the market opportunities for product
candidates; the ability to locate and acquire complementary
products or product candidates and integrate those into the
Company’s business; and, the uncertain effects of the COVID-19
pandemic; and those factors set forth in documents of BAC filed, or
to be filed, with SEC. The foregoing list of risks is not
exhaustive.
If any of these risks materialize or our assumptions prove
incorrect, actual results could differ materially from the results
implied by these forward-looking statements. There may be
additional risks that neither BAC nor the Target presently know or
that BAC and the Target currently believe are immaterial that could
also cause actual results to differ from those contained in the
forward-looking statements. In addition, forward-looking statements
reflect BAC’s and the Target’s current expectations, plans and
forecasts of future events and views as of the date of this press
release. BAC and the Target anticipate that subsequent events and
developments will cause BAC’s and the Target’s assessments to
change. However, while BAC and the Target may elect to update these
forward-looking statements at some point in the future, BAC and the
Target specifically disclaim any obligation to do so. These
forward-looking statements should not be relied upon as
representing BAC’s or the Target’s assessments as of any date
subsequent to the date of this press release. Accordingly, undue
reliance should not be placed upon the forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20220404005151/en/
Media – Michael Blash mblash@blademed.com | +1-650-453-0632
Investors – Krishna Gorti, M.D. kgorti@blademed.com |
+1-973-570-9438
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