- Positive preliminary data showed SENS-401 has a clinically
significant effect on the preservation of residual hearing after
cochlear implantation in all adult patients treated so far
- On the 19th of June, Sensorion announced that the patients
treated with SENS-401 showed presence of SENS-401 in perilymph.
Analysis suggests preservation of 21 dB of their residual hearing
compared to the control group six weeks after cochlear implantation
at 500 Hz
- Data to be detailed at a webinar today Wednesday, July 5,
2023, led by Professor Yann Nguyen M.D., Ph.D and Sensorion’s
management team
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 reports further analysis
from its Proof of Concept (POC) Phase 2a clinical trial of SENS-401
for residual hearing preservation in adult patients following
cochlear implantation. Analysis of the preliminary data will be
presented at the Company’s KOL webinar taking place today,
Wednesday, July 5, 2023 (event details below).
On June 19th, 2023, Sensorion announced that in preliminary data
from the Phase 2a study, SENS-401 was detected in the perilymph of
all 5 adult patients treated with the product. Levels of SENS-401
were considered consistent with potential therapeutic effects after
seven days of repeated oral treatment.
The data unveiled today shows that the study also assessed a
number of secondary endpoints, including 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. Further analysis suggests SENS-401
treated patients demonstrated the preservation of 21 dB of their
residual hearing compared to the control group six weeks after
cochlear implantation at 500 Hz.
In the SENS-401-treated group (N=5), the loss of residual
hearing was only 12 dB, contrasting with a larger loss of 33 dB
observed in the control group of four participants not treated with
SENS-401. This resulted in a difference of clinical significance of
21 dB between the two groups, suggesting SENS-401 provided a
protective effect on early residual hearing loss after cochlear
implantation. These original and promising findings reinforce the
hypothesis that SENS-401, by crossing the labyrinthine barrier to
reach the cochlear compartment, has a positive effect on the
preservation of residual hearing.
The Phase 2a trial is a multicentric, randomized, controlled
open-label trial aimed at evaluating the presence of SENS-401 in
the cochlea (perilymph) after 7 days of twice-daily oral
administration in adult patients prior to cochlear implantation due
to moderately severe to profound hearing impairment. Patients start
treatment with SENS-401 7 days before implantation and continue to
receive SENS-401 for a further 42 days.
Nawal Ouzren, Chief Executive Officer of Sensorion,
stated: “We are very excited to see such promising new preliminary
data for our ongoing Phase 2a clinical study of SENS-401. This is
great news for our program and supports our confidence in the
potential of our innovative therapy to prevent residual hearing
loss in adult patients suffering from moderately severe to profound
hearing disorders. This level of residual hearing preservation
means patients have a better chance of understanding speech against
background noise and perceiving more natural sound quality with
speech and sounds.”
Géraldine Honnet, M.D., Sensorion’s Chief Medical
Officer, added: “Two weeks ago we demonstrated that SENS-401
crossed the labyrinthine barrier to the cochlea. Today, following
further analysis, we have gone much further and have shown SENS-401
potential to preserve early residual hearing six weeks after
cochlear implantation. Patients treated with SENS-401 showed
improved hearing preservation compared to the patients in the
control group, corroborating the otoprotective potential of the
molecule. We believe SENS-401 is a ground-breaking therapy with
great potential in an area of significant unmet need and we are
looking forward to seeing the final results of the study.”
KOL Webinar
Sensorion’s KOL webinar, held today on Wednesday, July 5, 2023,
will feature a presentation by KOL Professor Yann Nguyen M.D.,
Ph.D., who will provide an overview on the importance of residual
hearing preservation and the surgical procedure developed for
perilymph sampling.
Sensorion’s management team will communicate further analysis of
the preliminary results of the POC Phase 2a study of SENS-401 for
the residual hearing preservation in patients who, due to
moderately severe to profound hearing impairment, are scheduled for
cochlear implantation. The study has been developed with
Sensorion’s partner, Cochlear Limited., the global leader in
implantable hearing devices.
A Q&A session will follow the formal presentations and the
webinar will be subtitled live. A replay of the call will also be
available.
Dr Yann Nguyen is an ENT professor at the Otolaryngology
Department, at the Hospital Pitié Salpêtrière (Sorbonne Université,
AP-HP), in Paris, France. His clinical activities are focused on
middle ear surgery, cochlear implantation and lateral skull base
surgery. He has a Ph.D. on “robot-based surgery for cochlear
implantation”. He is now working on robotics at the Hearing
Institute (Institut Pasteur/Inserm), and leads the “RobOtol
project”. Prof Nguyen’s goal is to design and evaluate surgical
solutions from lab bench to operating room for hearing loss.
Sensorion’s KOL Webinar Wednesday July 5th,
2023 11am – 12pm ET / 5pm – 6pm CET
To register for the KOL Webinar, please click
here
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. In
addition, Sensorion expects to evaluate SENS-401 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. 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
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/20230704456539/en/
Investor Relations Noémie Djokovic, Investor Relations
and Communications (Europe/France) ir.contact@sensorion-pharma.com
International Media Relations Consilium Strategic
Communications Jessica Hodgson/Sue Stuart/Isabelle Abdou +44 7561
424788 Sensorion@consilium-comms.com 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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