Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its trea...
17 Maggio 2021 - 6:03PM
Advicenne receives
positive feedback from the US FDA on pathway to approval and
amended Phase III study protocol for its treatment of distal renal
tubular acidosis (dRTA)
- FDA accepts amended protocol and
Advicenne will resume Phase III trial of its lead product ADV7103
(Sibnayal™) in the US in June 2021
- FDA guidance provides clear path
for market approval of ADV7103 in the United States
Paris, France,
17 May 2021 – 6
pm CEST – Advicenne (Euronext: ADVIC), a
specialty pharmaceutical company dedicated to developing and
commercializing innovative treatments for those suffering from rare
renal diseases, announces US Food and Drug Administration (FDA)
acceptance of the amended protocol of the Company’s US-based Phase
III pivotal trial of ADV7103 (Sibnayal™) for the treatment of
primary distal renal tubular acidosis (dRTA).
dRTA is an orphan disease of the kidney
affecting an estimated 30,000 patients in Europe and 20,000 in the
US for which no approved treatments currently exist.
Following the FDA’s written feedback, Advicenne
is moving forward with the ongoing restart of its pivotal dRTA
clinical Study (ARENA-2) in the US and Canada, with a clear plan
for study execution and regulatory strategy to ensure a clear path
for the market approval of ADV7103 in the United States. The trial
was halted last year due to challenges to its execution posed by
COVID-19.
Advicenne’s lead product, ADV7103, is developed
as a multi-particulate formulation in 2mm microtablets, a novel
pioneering delivery technology created by Advicenne that contains
two active pharmaceutical ingredients to ease its administration
and aid compliance and quality of life in patients of all ages.
Critically, the FDA has agreed that the proposed
primary endpoint of its Phase III pivotal trial of ADV7103
(Sibnayal™) for the treatment of dRTA in the US could serve as the
basis for full approval in patients with hereditary dRTA.
Dr. David Horn Solomon, Chairman at
Advicenne, commented: “We welcome the positive feedback by
the FDA which provides important clarity on the clinical roadmap
for ADV7103 in the United States and enables us to overcome the
challenges to its execution posed by the COVID-19 pandemic.
Following the recent approval by the European Commission to market
ADV7103 for the treatment of dRTA in Europe, Advicenne is on course
to commercialize a product with the potential of benefitting the
lives of patients in an area of high unmet need.”
Dr. André Ulmann, Chief Medical Officer
of Advicenne, said: “The feedback by the FDA represents
another very important milestone for Advicenne, providing key
information as we ultimately intend to commercialize ADV7103 in the
United States. With the approval of the amended study protocol,
which enables us to resume our pivotal Phase III trial, we are
optimistic that thousands of patients in the US will also be able
to benefit from this potentially life-changing treatment.”
About dRTA
Distal renal tubular acidosis (dRTA) is an
orphan disease characterized by a failure in the renal excretion of
acids generated through metabolism and for which there is no
approved treatment. The excess of acids thus accumulated in the
blood leads to an imbalance in pH (acidosis) as well as multiple
other complications such as growth retardation and rickets (a
disease affecting bone development) in children, and a series of
metabolic disorders such as low potassium levels, elevated calcium
in the urine resulting in kidney stones, the formation of calcium
deposits in the kidneys (calcinosis) as well as possible kidney
failure.
Whether genetic or acquired as a consequence of
an immune disease, dRTA affects an estimated 30,000 patients in
Europe and approximately 20,000 in the United States.
About Advicenne
Advicenne (Euronext: ADVIC) is a pharmaceutical
company founded in 2007, specializing in the development of
innovative treatments in Nephrology. Its lead drug candidate is
currently in late-stage clinical trials for two kidney diseases:
distal renal tubular acidosis and cystinuria. ADV7103 has just
received a Marketing Approval (MAA) for the treatment of dRTA.
Headquartered in Paris, Advicenne has been listed on the Euronext
Paris stock exchange since 2017 and was cross-listed on the
Euronext Brussels stock exchange in 2019.
For additional information see:
https://advicenne.com/
Contacts
AdvicenneDavid Solomon, ChairmanDidier Laurens,
CEO+33 (0)4 66 05 54 20Email: investors@advicenne.com |
NewCapFinancial communicationsDusan Oresansky,
Emmanuel Huynh+33 (0)1 44 71 94 94Merdia relationsNicolas
Merigeau+33 (0)1 44 71 94 98Email: advicenne@newcap.eu |
|
Consilium Strategic
CommunicationsMary-Jane
Elliott, Ashley Tapp, Davide Salvi+44 (0)20 3709 5700Email:
advicenne@consilium-comms.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Advicenne,
which shall not be considered per se as historical facts. Such
statements include projections and estimates, and the hypotheses on
which these are based, as well as observations relating to
operations, ongoing projects, objectives, the development of
products and their future performance, and expectations regarding
financial results.
In some cases, forward-looking statements can be
identified by words such as "could," "should," "may," "expects,"
"anticipates," "believes," "intends," "estimates," "aims,"
"targets" or similar words. Although the management of Advicenne
believes that these forward-looking statements are reasonably made,
investors should be aware that they are subject to a number of
known and unknown risks and uncertainties and other factors that
may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by these forward-looking
statements. In particular, the expectations of Advicenne could be
affected by, among other things, uncertainties involved in the
placing on the market and commercialization of Advicenne products
or any other risks and uncertainties developed or identified in any
public documents filed by Advicenne with the French Financial
Markets Authority (Autorité des marchés financiers (AMF)),
including those listed in Chapter 4, “Risk Factors,” of its
universal registration document, filed with the latter on December
22, 2020. Notwithstanding the compliance with article 223-1 of the
General Regulation of the AMF (the information disclosed must be
“accurate, precise and fairly presented”), Advicenne disclaims any
intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
- ADVIC_Reponse-FDA_FINAL_FR