Sensorion Announces New Positive Secondary Efficacy Endpoints Data From SENS-401 Phase 2a Clinical Trial For The Preservation Of Residual Hearing Loss
15 Julio 2024 - 12:30AM
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 the
publication of new positive data from its SENS-401 Phase 2a
clinical trial in the preservation of residual hearing in adult
patients following cochlear implantation.
New medical data and analysis of results from the SENS-401 Phase
2a clinical trial after cochlear implantation were presented at the
17th International Conference on Cochlear Implants and Other
Implantable Technologies (CI2024) on July 13, 2024, in Vancouver,
Canada, by study investigator, Professor Stephen O'Leary, M.D.,
Ph.D.
The study design included a number of secondary endpoints,
notably the change of hearing threshold from baseline to the end of
the treatment period in the implanted ear at several frequencies.
Study entry criteria required patients to have a pure tone
audiometry (PTA) threshold of 80 dB or better (i.e., ≤80 dB) at 500
Hz, defined as indicating a minimal level of residual hearing. The
results show that the administration of SENS-401 reduced hearing
loss following cochlear implantation. Six weeks post cochlear
implantation (corresponding to end of SENS-401 treatment), the data
indicate that the mean hearing loss induced by the surgery at 500
Hz is 19 dB for patients treated with SENS-401 (N=16) compared to
32 dB for control group of SENS-401 untreated patients (N=8).
Similar clinically meaningful difference is observed for the mean
of the three following frequencies (250, 500 and 750 Hz) with 16 dB
in the SENS-401 treated group compared to 31 dB in the control
group. These good results remained clinically meaningful over time
and up to the last study visit fourteen weeks after cochlear
implantation and confirm the key role of SENS-401 in preserving
residual hearing.
On March 11, 2024, Sensorion announced that it had successfully
met the primary endpoint of the SENS-401 clinical trial for the
preservation of residual hearing in adult patients following
cochlear implantation. The presence of SENS-401 in the perilymph at
a level compatible with potential therapeutic efficacy has been
confirmed in 100% of the patients sampled, seven days after the
start of the treatment, confirming that the primary endpoint was
met. These results confirm that SENS-401 administered orally
crosses the labyrinth barrier. The study is developed in
collaboration with Cochlear Limited, the global leader in
implantable hearing solutions.
Nawal Ouzren, Sensorion’s Chief Executive Officer, said:
"I am excited to share these new positive findings from our Phase
2a clinical trial on SENS-401, which demonstrate the clinically
meaningful effect of our small molecule in preserving the residual
hearing of patients undergoing cochlear implantation. Reaching this
key secondary endpoint strongly supports SENS-401’s ambition to
potentially improve the quality of hearing of patients undergoing
such surgery. We plan to communicate the full final data later in
Q3 2024. We remain entirely focused on developing our hearing care
franchise by developing our portfolio of very innovative therapies
to address important hearing loss disorders, a significant global
unmet need.”
Géraldine Honnet, M.D., Sensorion’s Chief Medical Officer,
said: "The new results obtained for SENS-401 show the efficacy
of the drug candidate in preserving residual hearing. I am
delighted to report the difference in hearing loss between the
treated group and the control group and the maintenance of this
effect up to 14 weeks post implantation with 25 dB loss at 500 Hz
in the treated group compared to 35 dB loss in the control group. I
would like to extend my gratitude to every patient, partner and
investigator who participated in this study.”
The Company plans on communicating the full final data later in
Q3 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 currently
develops SENS-401 in a Phase 2a 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) currently being
developed in a Phase 1/2 clinical trial, 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
2023 full year report published on March 14, 2024, 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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Investor Relations Noémie Djokovic, Investor Relations
and Communication Associate ir.contact@sensorion-pharma.com
Press Relations Ulysse Communication Bruno Arabian / 00
33(0)6 87 88 47 26 barabian@ulysse-communication.com Nicolas Entz /
00 33 (0)6 33 67 31 54 nentz@ulysse-communication.com
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