Third Harmonic Bio Announces Discontinuation of Phase 1b Study of THB001 in Chronic Inducible Urticaria
15 Diciembre 2022 - 6:00AM
Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical
company focused on advancing the next wave of medicine for
inflammatory diseases, today announced that the company has made
the decision to discontinue the ongoing Phase 1b study of its
investigational drug candidate, THB001, after observing
asymptomatic liver transaminitis in two subjects enrolled in the
first dose cohort of 200mg BID.
“We hold patient safety as our top priority in the conduct of
our clinical studies, and therefore have decided to terminate the
Phase 1b study of THB001,” said Natalie Holles, Chief Executive
Officer of Third Harmonic Bio. “While this is a deeply
disappointing outcome, we are encouraged by the preliminary signs
of clinical activity at this starting dose and are optimistic about
the potential for a selective oral wild-type KIT inhibitor to
become an important treatment modality for mast cell-driven
inflammatory diseases. Our early decision to invest in
next-generation medicinal chemistry enables us to maintain our
leadership position in oral wild-type KIT inhibition with the
anticipated nomination of a new development candidate next
year.”
The Company is initiating nonclinical studies to elucidate the
mechanism for the observed transaminitis, which was not predicted
by extensive GLP toxicology studies of THB001 nor observed in the
Company’s Phase 1a study. In parallel with the early clinical
development of THB001, the Company has conducted an extensive
medicinal chemistry effort to identify chemically distinct
next-generation oral wild-type KIT inhibitors and has advanced
multiple candidate molecules into exploratory toxicology studies.
The Company intends to nominate a development candidate from this
program in 2023.
The Phase 1b clinical trial in chronic inducible urticaria was
designed to evaluate the safety and tolerability, efficacy and
pharmacokinetics of three dose levels of THB001 over 12 weeks of
treatment. Five subjects were enrolled in the first dose cohort of
200mg BID. The first subject completed the full 12-week dosing
period with no signs or symptoms of liver toxicity. The second and
third subjects presented with elevations in alanine transaminase
(ALT) and aspartate transaminase (AST) at their week 8 study
visits, and dosing was halted for both subjects. All other
laboratory and diagnostic measures have indicated no change in
liver function in either subject and both subjects remain
clinically asymptomatic. No alternate causes for the transaminitis
have been identified, and the subjects continue to be closely
monitored. Dosing of the fourth and fifth subjects enrolled has
been stopped by the Company at weeks 4 and 2 of dosing,
respectively, and neither of these subjects has any signs or
symptoms of liver toxicity to date. Clinical follow-up of the five
enrolled subjects will continue per protocol, but no additional
subjects will be enrolled in the trial.
Preliminary analyses show evidence of pharmacodynamic and
clinical activity at the 200mg BID dose. The Company plans to
present the full data set from the five enrolled subjects at an
upcoming scientific conference, and to provide an update on overall
corporate strategy and outlook in early 2023.
About Third Harmonic Bio
Third Harmonic Bio is a biopharmaceutical company focused on
advancing the next wave of medicine for inflammatory diseases
through the development of a novel highly selective, oral
small-molecule inhibitor of KIT, a cell surface receptor that
serves as the master regulator of mast cell function and survival.
Early clinical studies demonstrate that KIT inhibition has the
potential to revolutionize the treatment of a broad range of
mast-cell-mediated inflammatory diseases, and that a titratable,
oral, intracellular small molecule inhibitor may provide the
optimal therapeutic profile against this target. For more
information, please visit the Third Harmonic Bio website:
www.thirdharmonicbio.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding the timing of additional corporate
announcements and presentations, the results and timing of
preclinical studies and clinical trials for future development
candidates, expectations regarding cash forecasts, and planned
clinical and development activities and timelines. Forward-looking
statements can be identified by words such as: "anticipate,"
"intend," "plan," "goal," "seek," "believe," "project," "estimate,"
"expect," "strategy," "future," "likely," "may," "should," "will"
and similar references to future periods. These statements are
subject to numerous risks and uncertainties, including risks and
uncertainties related to Third Harmonic’s cash forecasts, ability
to advance its product candidates, the receipt and timing of
potential regulatory submissions, designations, approvals and
commercialization of product candidates, our ability to protect our
intellectual property, the timing and results of preclinical and
clinical trials, changes to laws or regulations, market conditions,
geopolitical events, and further impacts of the ongoing COVID-19
pandemic, that could cause actual results to differ materially from
what Third Harmonic Bio expects. Further information on potential
risk factors that could affect Third Harmonic Bio’s business and
its financial results are detailed under the heading “Risk Factors”
included in Third Harmonic Bio’s prospectus dated September 14,
2022 filed with the U.S. Securities and Exchange Commission (SEC)
on September 15, 2022, and Third Harmonic Bio’s annual and
quarterly reports and other filings with the SEC filed from time to
time with the SEC. Third Harmonic Bio undertakes no obligation to
publicly update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Media Contact:Lori
Murraylori.murray@thirdharmonicbio.com
Investor Contact:Bob
Horho@thirdharmonicbio.com
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