Sensorion Announces Approval to Initiate amended Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity in France
24 Octobre 2022 - 7:30AM
Business Wire
Regulatory News:
Sensorion (FR0012596468 – ALSEN), a pioneering
clinical-stage biotechnology company which specializes in the
development of novel therapies to restore, treat and prevent within
the field of hearing loss disorders, today announces that the
initiation of a Proof of Concept (PoC) clinical trial of SENS-401
(Arazasetron) in patients with Cisplatin-Induced Ototoxicity (CIO)
has been approved by regulatory authorities in France.
Cisplatin and other platinum-based compounds are essential
chemotherapeutic agents for many cancers. A serious side effect of
these therapies is ototoxicity, or permanent and irreversible
hearing loss, in 50-60% of adult patients and 90% of pediatric
patients who survive cancer. This indication represents a very
significant unmet need for patients and is a large market with an
estimated incidence of more than 500,000 patients in the United
States, the European Union and Japan.
Approval has been granted to conduct a Phase 2a trial with
SENS-401 in CIO. Following extensive analysis of the AUDIBLE-S
study data earlier in 2022, Sensorion has adapted the design of
this trial to focus the prevention of hearing loss.
The exploratory, Phase 2a, multicenter, randomized, controlled,
open-label study, NOTOXIS, will evaluate the efficacy of SENS-401
to prevent the ototoxicity induced by cisplatin in adult subjects
with a neoplastic disease. The trial will assess several endpoints,
including the rate and severity of ototoxicity, the change in the
pure tone audiometry PTA (dB) and tolerance. First patient
enrolment is expected by end of 2022.
Géraldine Honnet, Chief Medical Officer of Sensorion,
said, “Cisplatin is an essential and life-saving chemotherapy for
millions of patients with cancer. Unfortunately, a devastating side
effect for the majority of cancer survivors who have received this
therapy is permanent and irreversible hearing loss. We are
delighted to have received approval for our clinical trial recently
amended with SENS-401, which we believe has the potential to
preserve hearing for patients receiving cisplatin.”
About SENS-401 SENS-401 (Arazasetron), Sensorion’s
clinical stage lead drug candidate, is an orally available small
molecule that aims to protect and preserve inner ear tissue from
damage responsible of progressive or sequelae hearing impairment.
Sensorion currently develops SENS-401 in a Phase 2a clinical trial
for the prevention of residual hearing loss in patients scheduled
for cochlear implantation, and in a Phase 2 clinical trial for the
prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been
granted Orphan Drug Designation by the EMA in Europe for the
treatment of sudden sensorineural hearing loss, and by the FDA in
the U.S. for the prevention of platinum-induced ototoxicity in
pediatric population.
About Sensorion Sensorion is a pioneering clinical-stage
biotech company, which specializes in the development of novel
therapies to restore, treat and prevent hearing loss disorders, a
significant global unmet medical need.
Sensorion has built a unique R&D technology platform to
expand its understanding of the pathophysiology and etiology of
inner ear related diseases, enabling it to select the best targets
and mechanisms of action for drug candidates. Its portfolio
combines both small molecule programs and a preclinical portfolio
of inner ear gene therapies.
Its clinical-stage portfolio includes one Phase 2 product:
SENS-401 (Arazasetron) progressing in a Phase 2 proof of concept
clinical trial of SENS-401 in Cisplatin-Induced Ototoxicity (CIO)
and, with partner Cochlear Limited, in a Phase 2a study of SENS-401
in patients scheduled for cochlear implantation.
Sensorion pursues its broad strategic collaboration with
Institut Pasteur focused on the genetics of hearing. It has two
gene therapy programs aimed at correcting hereditary monogenic
forms of deafness including OTOF-GT, targeting deafness caused by a
mutation of the gene encoding for otoferlin, and hearing loss
related to mutation in GJB2 gene to potentially address important
hearing loss segments in adults and children (GJB2-GT). The Company
is also working on the identification of biomarkers to improve
diagnosis of these underserved illnesses.
www.sensorion.com
Label: SENSORION ISIN: FR0012596468 Mnemonic:
ALSEN
Disclaimer This press release contains certain
forward-looking statements concerning Sensorion and its business.
Such forward looking statements are based on assumptions that
Sensorion considers to be reasonable. However, there can be no
assurance that such forward-looking statements will be verified,
which statements are subject to numerous risks, including the risks
set forth in the 2021 full year financial report published on April
28, 2022, and available on our website and to the development of
economic conditions, financial markets and the markets in which
Sensorion operates. The forward-looking statements contained in
this press release are also subject to risks not yet known to
Sensorion or not currently considered material by Sensorion. The
occurrence of all or part of such risks could cause actual results,
financial conditions, performance or achievements of Sensorion to
be materially different from such forward-looking statements. This
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Any recipient of this press release must inform oneself of any such
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Investor Relations Noemie Djokovic Investor Relations and
Communications +33 6 76 67 98 31
ir.contact@sensorion-pharma.com
International Media Relations Consilium Strategic
Communications Matthew Cole/Jessica Hodgson +44 7593 572720 +44
7561 424788 Sensorion@consilium-comms.com
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