- Sensorion reported positive initial safety data on the First
Patient Injected in Audiogene, its Phase 1/2 gene therapy clinical
trial of SENS-501
- Sensorion announced positive final results of the Phase 2a
clinical trial of SENS-401 after cochlear implantation
- Sensorion reported preliminary safety and efficacy data in
the NOTOXIS trial, a Phase 2a clinical study of SENS-401 in the
prevention of Cisplatin-Induced Ototoxicity
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 detailed
results of its clinical programs (SENS-501 and SENS-401), which
were unveiled on September 20, 2024, during a symposium hosted by
the Company and an oral presentation at the 36th World Congress of
Audiology, held in Paris, France.
Nawal Ouzren, Chief Executive Officer of Sensorion, said:
“Sensorion is making tremendous progress across its hearing care
franchise of innovative therapies for the restoration, prevention
and treatment of hearing loss disorders. Notably, we have made
significant advances in our gene therapy clinical trial, Audiogene,
for the restoration of hearing in very young patients born with
severe to profound hearing loss caused by mutations in the gene
encoding for otoferlin. This program received regulatory approval
in January 2024, and we are today confident that we will have
treated the first cohort of patients by year end 2024, with one
patient already injected and two additional patients already
screened. I am very thankful to the parents of these patients for
their trust and also to the study investigators participating in
this study for their dedication.
I am also very pleased with the progress made with SENS-401
portfolio. We have reported the final results, including the
positive secondary efficacy endpoints, of our Phase 2a clinical
trial for the preservation of residual hearing, developed in
collaboration with Cochlear Limited. Our second Phase 2a clinical
trial of SENS-401, in the prevention of Cisplatin-Induced
Ototoxicity, is progressing as planned and I am looking forward to
the completion of the recruitment in H1 2025.
Sensorion is more than ever striving to advance its innovative
programs to potentially transform the quality of hearing of
patients living with hearing disorders, a significant global unmet
medical need.”
- SENS-501 (OTOF-GT) / Audiogene
Sensorion announced that the first patient in the Audiogene
trial has been injected in Q3 2024 in Australia by the team of
Professor Catherine Birman, Otorhinolaryngologist, and Director of
the Sydney Cochlear Implant Centre.
Audiogene aims to evaluate the safety, tolerability, and
efficacy of intra-cochlear injection of SENS-501 for the treatment
of OTOF gene-mediated hearing impairment in paediatric patients
aged 6 to 31 months at the time of gene therapy treatment.
Targeting the first years of life, the time period when the
auditory system plasticity is optimal, will maximize the chances of
these young children with pre-lingual hearing loss to acquire
normal speech and language. The design of the study consists of two
cohorts of two doses followed by an expansion cohort at the
selected dose. While the safety will be the primary endpoint for
the dose escalation cohort, the auditory brainstem response (ABR)
will be the primary efficacy endpoint of the dose expansion cohort.
Audiogene will also assess the clinical safety, performance, and
usability of the administration device system developed by
Sensorion.
According to the inclusion criteria, the first patient enrolled
in Audiogene suffers from profound to severe hearing loss caused by
mutations of the gene encoding for otoferlin. The administration of
the gene therapy product was uneventful and well tolerated by the
patient. Initial safety data indicate that no serious or adverse
events were detected in the child following administration of
SENS-501. The medical condition of the child (upper respiratory
infection unrelated to SENS-501 injection) at the time of efficacy
assessment (ABR Month 1) did not allow to get reliable hearing
sensitivity. From early observations, changes in the child's
behaviour and vocalisations were noted.
Sensorion continues the recruitment of patients in Audiogene
Phase 1/2 study and announces that two additional patients have
been screened. The Company anticipates the completion of the first
cohort of patients (three patients) by the end of 2024 as well as
the publication of initial efficacy data by year-end 2024. The
recruitment completion of the second cohort (3 patients) is planned
by the end of the first half of 2025.
Professor Catherine Birman, ENT, Otorhinolaryngologist, and
Director of the Sydney Cochlear Implant Centre, declared: “I am
very excited to participate in this groundbreaking gene therapy
trial that may have the potential to transform the lives of the
babies carrying the OTOF gene mutation. I am grateful to the family
of the first patient to receive the gene therapy for placing their
trust in this innovative approach and potentially paving the way
for the use of gene therapies in the field of hearing loss. I am
looking forward to following the progress of the first patient in
the follow-up period and further recruitment of patients in
Audiogene assessing SENS-501 efficacy.”
- SENS-401 / Cochlear Implantation
Sensorion’s Phase 2a clinical study of SENS-401 for the
preservation of residual hearing loss after cochlear implantation
is now completed with the last patient having completed the
follow-up period. Overall, 16 patients were treated with SENS-401
and 8 were in the control group. The Company reported the analysis
of the final results during its symposium, held at the World
Congress of Audiology, on September 20, 2024.
As a reminder, the study is a multicenter, randomized,
controlled, open-label trial designed to assess the presence of
SENS-401 in the perilymph after 7 days of repeated oral
administration in adult participants over 18 years old undergoing
cochlear implantation. On March 11, 2024, Sensorion confirmed the
presence of SENS-401 in the perilymph at levels compatible with
potential therapeutic efficacy in 100% of the patients sampled, 7
days after the start of the treatment. These results demonstrated
that SENS-401 administered orally crossed the labyrinth barrier and
confirmed that the primary endpoint was met.
The study design also 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 final results show that after 7 weeks of treatment with
SENS-401 (and 6 weeks after cochlear implantation), the reduction
in residual hearing loss was systematically better at all
frequencies in the treated group with SENS-401. This protective
effect was also observed 8 weeks after cessation of treatment (14
weeks post-cochlear implantation). The results show that solely the
SENS-401 treated patients showed a complete hearing preservation
(40% of patients) compared to the control group (0% of
patients).
Additionally, these data validate the favourable safety profile
of SENS-401 in treated patients, in line with previous studies of
125 patients exposed to SENS-401.
These positive results strongly support the continuation of the
clinical development of SENS-401 for hearing preservation in
treated patients.
Stephen O’Leary, Head of otorhinolaryngology, University of
Melbourne said: “The final results of the SENS-401 Phase 2a
study are very encouraging as they support the conclusion that the
administration of SENS-401 preserves residual hearing in patients
undergoing cochlear implantation. This represents a crucial step
towards for cochlear implantation candidates as residual hearing is
very important to maintain and improve the quality of hearing of
such patients. Residual hearing loss usually occurs mainly in the
first 6 months after surgery; thus, early action is crucial.
These positive data encourage us to pursue the clinical
development of SENS-401, in order to offer innovative therapeutic
treatments to patients scheduled for cochlear implantation as the
level of residual hearing preservation showed in the study means
patients have a better chance of understanding speech against
background noise and perceiving more natural sound quality with
speech and sounds.”
- SENS-401 (Cisplatin-Induced Ototoxicity,
CIO) / NOTOXIS
Sensorion is conducting another clinical study of SENS-401 in
the prevention of Cisplatin-Induced Ototoxicity (CIO). NOTOXIS is a
Phase 2a, multi-center, randomized, controlled and open-label study
designed to assess the efficacy of SENS-401 in the prevention of
CIO in adult subjects with neoplastic disease. The preliminary
analyses presented were conducted on 16 patients (7 in the treated
with SENS-401 group, and 9 in the control group).
The preliminary results presented indicate that the incidence of
ototoxicity in the control group is consistent with published data.
Despite significant exposure to cisplatin in the treatment group,
most participants showed only mild ototoxicity. The SENS-401 group
received higher cumulative doses of cisplatin than the control
group. The preliminary results suggest a potential trend toward an
otoprotective effect of SENS-401 beyond a cisplatin dose of 300
mg/m2.
SENS-401 showed a favourable safety profile with no new or
unexpected serious adverse events after 23 weeks of twice-daily
oral exposure, a longer duration than previous studies. Safety
results are consistent with previous studies involving a total of
125 patients exposed to SENS-401.
Adverse events reported included constipation and nausea, as
expected.
These preliminary data suggest that the cumulative dose of
cisplatin is a key factor in the severity of ototoxicity. So far,
the data show no significant difference in ototoxicity between the
2 groups. Patients most exposed to cisplatin may benefit more from
the otoprotective effect of SENS-401.
Sensorion anticipates the patient recruitment completion in H1
2025. A more detailed analysis will be carried out on all patients
at the end of the study.
Professor Yann Nguyen, ENT Surgeon, Pitié Salpétrière
Hospital, Paris, France, declared: “The results of the Phase 2a
study of SENS-401 in the NOTOXIS program are encouraging.
Ototoxicity is a debilitating condition in patients following
cisplatin-based chemotherapy. Hearing loss caused by cisplatin is
often diagnosed when it's too late, and it is permanent and
irreversible. Therefore, it is paramount to pursue the development
of a therapeutic solution, that has the potential to prevent
cisplatin-induced ototoxicity without interfering with cisplatin
efficacy. I am very satisfied with the drug safety profile and the
otoprotective trend suggested by the preliminary data, and I am
impatient to advance Sensorion’s small molecule further in this
study.”
A recording of the symposium held on September 20, 2024, at the
World Congress of Audiology will be available on the Company’s
website in the coming days.
About SENS-501
SENS-501 (OTOF-GT) is an innovative gene therapy program
developed to treat a specific form of congenital deafness linked to
mutations in the OTOF (otoferlin) gene. This gene plays a key role
in the transmission of auditory signals between the hair cells of
the inner ear and the auditory nerve. When this gene is defective,
affected individuals are born with severe to profound hearing
loss.
The aim of SENS-501 (OTOF-GT) is to restore hearing by
introducing a functional copy of the OTOF gene directly into hair
cells via viral vector technology (AAV). By replacing the defective
gene, this therapy aims to restore the normal process of converting
sound into electrical signals, enabling patients to regain their
hearing ability.
Currently in the pre-clinical research phase, this gene therapy
program represents significant hope for families affected by this
rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a
commitment to scientific innovation in the field of hearing, with
the potential to dramatically improve the quality of life of
patients suffering from genetic deafness.
This gene therapy for patients suffering from otoferlin
deficiency has been developed in the framework of RHU AUDINNOVE, a
consortium composed of Sensorion with the Necker Enfants Malades
Hospital, the Institut Pasteur, and the Fondation pour l’Audition.
The project is partially financed by the French National Research
Agency, through the “investing for the future” program (ref:
ANR-18-RHUS-0007).
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 2 clinical trial for the prevention of
Cisplatin-Induced Ototoxicity and has completed a Phase 2a study to
prevent residual hearing loss in patients scheduled for cochlear
implantation. 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, has completed
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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version on businesswire.com: https://www.businesswire.com/news/home/20240922873162/en/
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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