Centessa Pharmaceuticals Makes Strategic Decision to Discontinue Clinical Development of Lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
June 02 2022 - 5:29AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced that
it has made the strategic decision to discontinue development of
lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
including both the Phase 3 ACTION Study and the open-label ALERT
Study. The decision is based on a thorough reassessment of the
commercial potential of lixivaptan as a potential best-in-class
therapy for patients with ADPKD, and the incremental development
challenges and associated costs, following a recent observation of
alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
elevations in one subject in the ALERT Study.
“The ALERT Study was designed to help provide an early
assessment of the safety profile of lixivaptan in ADPKD patients
who previously experienced liver chemistry abnormalities while
treated with tolvaptan, the only FDA approved therapy for ADPKD. In
assessing the recent data from a subject in the ALERT Study, we
believe that lixivaptan is unlikely to achieve the differentiated
safety and tolerability profile Centessa required for further
development of the program. Given the revised commercial potential
of lixivaptan and our commitment to being financially disciplined,
we made the data-driven decision to voluntarily discontinue
development of lixivaptan,” said Saurabh Saha, MD, PhD, Chief
Executive Officer of Centessa. “As an organization focused on
developing best-in-class therapies and innovative medicines for
patients, we had hoped lixivaptan would provide patients with ADPKD
a safer alternative treatment option to the current approved
therapy. We are incredibly grateful to all the patients, their
families and the investigators who participated in the lixivaptan
trials and contributed to this research.”
Dr. Saha continued, “Going forward, we remain focused on
continuing to advance our innovative rare disease and
immuno-oncology programs with the potential for multiple clinical
proof of concept readouts over the next 12 to 24 months. With our
decision to discontinue development of lixivaptan, we believe we
are well positioned with the capital and resources to execute these
programs. We expect a significant reduction in annual cash burn and
that our cash runway will now extend into 2026.”
About the ACTION Study
The ACTION Study was a Phase 3 trial consisting of a two-arm,
double-blind, placebo-controlled, randomized phase (“Part 1”)
followed by a single-arm, open-label phase (“Part 2”). The ACTION
Study was designed to evaluate the efficacy and safety of
lixivaptan in subjects with ADPKD. Further information on the
ACTION Study can be found at clinicaltrials.gov at
https://clinicaltrials.gov/ct2/show/NCT04064346
About the ALERT Study
The ALERT Study was an open-label, non-registrational
repeat-dose study designed to assess liver and non-liver safety in
subjects who previously experienced liver chemistry test
abnormalities while treated with tolvaptan and were permanently
discontinued from the drug for that reason. Further information on
the ALERT Study can be found at clinicaltrials.gov at
https://clinicaltrials.gov/ct2/show/NCT04152837
About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc (“Centessa”) is a clinical-stage
pharmaceutical company with a Research & Development
(“R&D”) innovation engine that aims to discover, develop and
ultimately deliver impactful medicines to patients. Our programs
span discovery-stage to late-stage development and cover a range of
high-value indications in rare diseases and immuno-oncology. We are
led by a management team with extensive R&D experience,
providing direct guidance to our program teams to rapidly advance
our candidates from research through all stages of development. For
more information, visit www.centessa.com, which does not form part
of this release.
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CONTACT:
Kristen K. Sheppard, Esq.
Senior Vice President Investor Relations
investors@centessa.com
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