- Preliminary data demonstrate that SENS-401 has a favorable
safety profile when administered continuously for up to 11 weeks in
adult patients undergoing cisplatin-based chemotherapy
- Recruitment is progressing well, with over a third of the
required study population enrolled
- Sensorion will provide further updates of its Proof of
Concept (POC) Phase 2a clinical trial of SENS-401 CIO during the
World Congress of Audiology, being held on September 19-22, 2024,
in Paris, France
- The POC Phase 2a clinical trial of SENS-401 in the
prevention of residual hearing loss after cochlear implantation is
advancing as planned. The end of patient recruitment is anticipated
early 2024
Regulatory News:
Sensorion (FR0012596468 – ALSEN) (Paris: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 disorders, today announces preliminary
safety results from NOTOXIS, its Phase 2a Proof of Concept (POC)
clinical trial of SENS-401 (Arazasetron) in patients suffering from
Cisplatin-Induced Ototoxicity.
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, which frequently occurs in about 60% of adult and
pediatric patients treated with this drug. This indication
represents a very significant unmet medical need for patients and
is a large potential market with an estimated incidence of more
than 500,000 patients in the United States, the European Union and
Japan.
The Phase 2a NOTOXIS trial is a multicenter, randomized,
controlled, open-label study, designed to evaluate the efficacy of
SENS-401 to prevent ototoxicity induced by cisplatin in adult
patients with a neoplastic disease 4 weeks after the completion of
cisplatin-based chemotherapy. The trial assesses several outcome
measures, including the rate and severity of ototoxicity, the
change from baseline in Pure Tone Audiometry (PTA) (dB) throughout
the study and the tolerance.
Eligible participants are randomized on Day 1 to either Arm A or
Arm B in ratio 1:1. In Arm A, patients receive 43.5mg of oral
SENS-401 one week before the start of the chemotherapy, continues
throughout the entire chemotherapy duration, and extends for up to
four weeks post-chemotherapy. This study is conducted in comparison
to a control group of patients receiving chemotherapy alone, Arm B.
The patients entering the study are to receive high doses of
cisplatin, exceeding 70mg/m2 per treatment cycle and totalling at
least 210 mg/m2 over the course of their chemotherapy regimen.
Following the enrolment of over one-third of the required study
population, preliminary safety data for patients exposed to a daily
dose of 43.5 mg SENS-401 administered b.i.d. for up to 11 weeks
indicate a favorable profile consistent with previously reported
data for patients exposed for up to 7 weeks.
Recruitment is progressing at a sustained path, with 11 clinical
centers open to date. Sensorion’s management team will communicate
further updates of the POC Phase 2a clinical study of SENS-401 in
Cisplatin-Induced Ototoxicity during the World Congress of
Audiology, being held on September 19-22, 2024, in Paris,
France.
Géraldine Honnet, Chief Medical Officer of Sensorion,
said: “I’m pleased with the progress in Sensorion’s POC Phase 2a
clinical study of SENS-401 in the prevention of Cisplatin-Induced
Ototoxicity. These are encouraging preliminary safety results and
build on the data we have seen to date for SENS-401, our first
in-class drug candidate that could prevent hearing loss induced by
cisplatin. Our constant effort to include new clinical centers
within this study and to accelerate the pace of recruitment have
paid off. SENS-401 is also progressing in a second ongoing Phase 2a
clinical study in the prevention of residual hearing loss following
cochlear implantation. We are anticipating the end of recruitment
early 2024. Sensorion remains highly focused on developing
innovative therapies that may have the potential to ultimately
transform the quality of life for patients suffering from hearing
disorders.”
Professor Christophe Tournigand, M.D., Ph.D., Head of the
Oncology Department at Henri Mondor Hospital in Créteil, France
said: "Educating patients about the irreversible and
permanent hearing loss frequently seen in adult patients undergoing
cisplatin-based chemotherapies can be challenging, as it may seem
inconsequential in the context of the cancer they are battling.
However, this effort is necessary to pursue the development of a
therapeutic solution, that may have the potential to effectively
prevent cisplatin-induced ototoxicity.”
Professor Yann Nguyen M.D., Ph.D., ENT surgeon at the
Otolaryngology Department at the Hospital Pitié Salpêtrière, Paris,
France, commented: "It has become paramount to acknowledge the
severe and irreversible hearing losses that frequently follow
cisplatin treatments and to encourage the development of
therapeutic solutions to mitigate this severe effect without
interfering with cisplatin efficacy."
In a preclinical model of Cisplatin-Induced Ototoxicity
(Petremann et al., 2017), SENS-401 demonstrated an ability to
significantly reduce hearing loss without impacting
chemotherapeutic potential of cisplatin. Additionally, further
analysis of the AUDIBLE-S study in March 2022, to assess the effect
of SENS-401 in Sudden Sensorineural Hearing Loss (SSNHL)
demonstrated a statistically significant and clinically meaningful
treatment effect of at least 10 dB vs placebo with the high dose at
Day 84 in the per protocol idiopathic SSNHL population (81
patients) treated with corticosteroids (representing c. 70% of the
Intent to Treat population). These data informed the NOTOXIS trial
design to extend exposition to SENS-401 treatment, in order to
cover all the cycles of cisplatin and to focus on the prevention of
hearing loss.
SENS-401 is also progressing in a POC Phase 2a clinical trial
for the prevention of residual hearing loss following cochlear
implantation, developed with its partner Cochlear Ltd, global
leader in implantable hearing devices. In June 2023, Sensorion
provided preliminary data, showing the presence of SENS-401 in the
perilymph of all five adult patients treated with the product. In
July 2023, the Company reported further preliminary data
demonstrating a clinically significant 21dB improvement in the
preservation of residual hearing compared to the control group 6
weeks after cochlear implantation at 500 Hz. Sensorion is
anticipating the end of patient recruitment early 2024 and the
publication of POC Phase 2a clinical primary endpoint readout in H1
2024.
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 is currently
developing 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. It has
two gene therapy programs aimed at correcting hereditary monogenic
forms of deafness, developed in the framework of its broad
strategic collaboration focused on the genetics of hearing with the
Institut Pasteur. SENS-501 (OTOF-GT) targets deafness caused by
mutations of the gene encoding for otoferlin and GJB2-GT targets
hearing loss related to mutations in GJB2 gene to potentially
address important hearing loss segments in adults and children. The
Company is also working on the identification of biomarkers to
improve diagnosis of these underserved illnesses. Sensorion’s
portfolio also comprises clinical-stage small molecule programs for
the treatment and prevention of hearing loss disorders.
Sensorion’s clinical-stage portfolio includes one Phase 2
product: SENS-401 (Arazasetron) progressing in a planned Phase 2
proof of concept clinical study of SENS-401 in Cisplatin-Induced
Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of
SENS-401 in patients scheduled for cochlear implantation. A Phase 2
study of SENS-401 was also completed in Sudden Sensorineural
Hearing Loss (SSNHL) in January 2022.
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
2022 full year financial report published on March 30, 2023, 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
press release and the information that it contains do not
constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, Sensorion shares in any
country. The communication of this press release in certain
countries may constitute a violation of local laws and regulations.
Any recipient of this press release must inform oneself of any such
local restrictions and comply therewith.
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version on businesswire.com: https://www.businesswire.com/news/home/20231217358010/en/
Investor Relations Noemie Djokovic, Investor Relations
and Communications Associate ir.contact@sensorion-pharma.com
International Media Relations Ulysse Communication
Pierre-Louis Germain / 00 33 (0)6 64 79 97 51
plgermain@ulysse-communication.com
Bruno Arabian / 00 00(0)6 87 88 47 26
barabian@ulysse-communication.com
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