Sensorion to Host Key Opinion Leader Webinar on July 5, 2023; Confirms Upcoming Key Milestones
07 Juin 2023 - 7:30AM
Business Wire
- SENS-401 update on the POC Phase 2a clinical study
evaluating SENS-401 in association with cochlear implantation
- KOL Webinar with Professor Yann Nguyen to be held on
Wednesday July 5, 2023, at 11am Eastern Time
- Key SENS-401 POC Phase 2a preliminary data on presence of
SENS-401 in the cochlea to be reported mid-June 2023
- First Clinical Trial Application filing for OTOF-GT on track
for end-June 2023
- OTOF-GT is Sensorion’s lead gene therapy program for the
treatment of otoferlin gene-mediated hearing loss
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, announces it will host a Key
Opinion Leader (KOL) webinar on Proof-of-Concept (POC) Phase 2a
study preliminary results of SENS-401 for residual hearing
preservation following cochlear implantation. Key data from the
Phase 2a study will be reported in June.
The webinar will feature a presentation by KOL Professor Yann
Nguyen M.D., Ph.D., ENT surgeon at the Otolaryngology Department at
the Hospital Pitié Salpêtrière, Paris, France, who will provide an
overview on the importance of residual hearing preservation and
will present the surgical procedure developed for perilymph
sampling.
Sensorion’s management team will provide an update on the
preliminary results of the POC Phase 2a study of SENS-401 for the
residual hearing preservation in patients who, due to having
moderately severe to profound hearing impairment, are scheduled for
cochlear implantation. The study has been developed with
Sensorion’s partner, Cochlear Ltd., the global leader in
implantable hearing devices.
A Q&A session will follow the formal presentations and the
webinar will be subtitled live.
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 participants prior to cochlear implantation
due to moderately severe to profound hearing impairment. Patients
start treatment with SENS-401 seven days before implantation and
continue to receive SENS-401 for a further 42 days. The study also
assesses a number of secondary endpoints, including the change of
hearing threshold from baseline to the end of the study in the
implanted ear at several frequencies.
Professor 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 he 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 on Wednesday 5,
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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Investor Relations David Lawrence, Chief Financial
Officer (US/UK) Noémie Djokovic, Investor Relations and
Communications (Europe/France) ir.contact@sensorion-pharma.com
International Media Relations Consilium1Strategic
Communications Jessica Hodgson / Sue Stuart +44 7921 917422 +44
7561 424788 Sensorion@consilium-comms.com
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