86 patients enrolled in SENS-111 clinical trial
MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering
clinical-stage biopharmaceutical company which specializes in the
development of novel therapies to restore, treat and prevent inner ear
diseases such as hearing loss, tinnitus and vertigo, today announced
that the independent Data Safety Monitoring Board (or DSMB) has
undertaken a review of the safety data for the 76 first patients having
completed the phase 2 clinical trial for SENS-111 in the treatment of
acute unilateral vestibulopathy (AUV).
The DSMB has confirmed the absence of any concern as to the safety of
SENS 111 and has recommended continuing the trial as scheduled and
enrolling the remaining patients.
86 patients have been enrolled so far. The number of expected patients
is some 100 in the centers open in the US, Europe, Israel and South
Korea.
Sensorion is thus well ahead in achievement of this trial and we confirm
that the trial results will be available in the second half of 2019 in
order to assess the efficacy of the candidate drug.
About Seliforant
Seliforant (formerly SENS-111) is the first representative candidate of
the histamine type 4 receptor antagonist class to be tested for the
symptomatic treatment of vertigo crises. Displaying a neuromodulation
effect of the sensorineural inner ear cell function, Seliforant is a
small molecule that can be taken orally or via a standard injection, and
is currently in a separate Phase 2 clinical trial, being conducted in
the United States, Europe, Israel and South Korea.
About Sensorion
Sensorion is a pioneering clinical-stage biopharmaceutical company,
which specializes in the development of novel therapies to restore,
treat and prevent inner ear diseases such as hearing loss, vertigo and
tinnitus. Our clinical-stage portfolio includes two phase 2 products:
Seliforant (SENS-111) in acute unilateral vestibulopathy and Arazasetron
(SENS-401) for sudden sensorineural hearing loss (SSNHL). We have built
a unique R&D technology platform to expand our understanding of the
pathophysiology and etiology of inner ear diseases enabling us to select
the best targets and modalities for drug candidates. We also identify
biomarkers to improve diagnosis and treatment of these underserved
illnesses.
We are uniquely placed through our platforms and pipeline of potential
therapeutics to make a lasting positive impact on hundreds of thousands
of people with inner ear related disorders; a significant global unmet
need in medicine today.
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 ‘Document de référence’
registration document filed with the ‘Autorité des Marchés Financiers’
(AMF French Financial Market Authority) on September 7th, 2017 under
n°R.17-062 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.
Contacts
Sensorion
Nawal Ouzren
CEO
contact@sensorion-pharma.com
Tel:
+33 467 207 730
Catherine Leveau
Financial communication
catherine.leveau@sensorion-pharma.com
Tel:
+33 467 207 730