RECORDATI: ISTURISA® (OSILODROSTAT) PHASE III LINC-4 TRIAL MEETS ITS PRIMARY ENDPOINT IN CUSHING’S DISEASE
17 Juin 2020 - 9:22AM
RECORDATI:
ISTURISA® (OSILODROSTAT)
PHASE III LINC-4 TRIAL MEETS ITS PRIMARY ENDPOINT IN CUSHING’S
DISEASE
Isturisa® (osilodrostat) demonstrates
significant and sustained benefit over placebo at normalizing mean
urinary free cortisol (mUFC) levels in patients with Cushing’s
disease
Milan, 17 June 2020 – Recordati today announces
positive results from the large Phase III LINC-4 study of
Isturisa® (osilodrostat) for the treatment of patients with
Cushing’s disease for whom pituitary surgery is not an option or
has not been curative. Data from the LINC-4 study demonstrate that
a significantly higher proportion of patients receiving Isturisa®
achieve normal mUFC, the primary treatment goal for Cushing’s
disease, after 12 weeks of treatment versus placebo (77% vs 8%;
P<0.0001). Improvements in mUFC levels are sustained over 36
weeks of treatment (81% of patients). Isturisa® is well tolerated
and has a manageable safety profile, with the most common adverse
events in LINC-4 being arthralgia, decreased appetite, fatigue, and
nausea. The findings from LINC-4, the first Phase III study of
a medical therapy in Cushing’s disease to contain an upfront
placebo-controlled phase, builds on existing clinical evidence and
affirms the effectiveness of Isturisa® in this hard-to-treat
patient population.1-3
“Cushing’s disease is a chronic and debilitating
condition that can be extremely challenging to manage and, if left
inadequately treated, can have a significant impact on patients’
quality of life and increase the risk of mortality”, said Richard
Feelders, MD, Professor of Endocrinology at the Erasmus University
Medical Centre, Rotterdam. “Data from this important Phase III
study show that Isturisa® (osilodrostat) is an effective and
well-tolerated therapy for Cushing’s disease, which significantly
reduces and normalizes mUFC levels in most patients. These data are
encouraging given the high unmet medical need for patients with
this rare disorder”.
“The compelling topline LINC-4 data confirm the
effectiveness of Isturisa® for the treatment of this rare,
potentially life-threatening disease”, stated Andrea Recordati,
CEO. “We are deeply grateful to the patients, investigators,
clinicians and study staff whose ongoing participation in the
clinical development of Isturisa® has helped bring this therapy to
patients in need.”
Data from the LINC 4 study reinforce the
clinical benefits of Isturisa® as an effective and generally
well‑tolerated oral treatment option for patients with Cushing’s
disease. Isturisa® has recently received marketing authorization in
the European Union (January 2020) and United States (March 2020)
for the treatment of Cushing’s syndrome and Cushing’s disease,
respectively.
About Cushing’s syndrome
Cushing’s syndrome is caused by an inappropriate
and chronic exposure to excessive levels of cortisol. The source of
this excess of cortisol can be endogenous or exogenous (ie
medication). When the excess cortisol production is triggered by a
pituitary adenoma (ie a tumor of the pituitary gland located in the
brain) secreting excess adrenocorticotropic hormone (ACTH), the
condition of the patient is defined as Cushing’s disease and
comprises about 70% of Cushing’s syndrome cases.4 It is a rare,
serious and difficult-to-treat disease that affects approximately
one to two patients per million per year.5 Prolonged exposure to
elevated cortisol levels is associated with considerable morbidity,
mortality and impaired quality of life as a result of complications
and comorbidities.6 Normalization of cortisol levels is therefore a
primary objective in the treatment of Cushing’s syndrome.7
About LINC-4
LINC-4 is a large randomized, double-blinded,
multicentre, 48-week trial with an initial 12-week
placebo-controlled period to evaluate the safety and efficacy of
osilodrostat in patients with Cushing’s disease. The primary
endpoint in the LINC-4 trial is the proportion of patients
randomized to Isturisa® and placebo, separately, with a mUFC ≤ULN
at the end of the 12-week placebo-controlled period. The key
secondary endpoint is the proportion of patients in both arms
combined with a mUFC ≤ULN after 36 weeks. LINC-4 involved 73
patients with persistent or recurrent Cushing’s disease or those
with de novo disease who were not candidates for surgery.
About Isturisa®
Isturisa® is a potent oral, reversible inhibitor
of 11β-hydroxylase (CYP11B1), the enzyme that catalyses the final
step of cortisol biosynthesis in the adrenal gland and is
authorized in the EU and US for the treatment of adult patients
with Cushing’s syndrome and Cushing’s disease, respectively.8,9
Isturisa® will be available as 1 mg, 5 mg and 10 mg
film‐coated tablets. Please see prescribing information for
detailed recommendations for the use of this product.8,9
- Bertagna X et al. J Clin Endocrinol Metab 2014;99:1375–83
- Fleseriu M et al. Pituitary 2016;19:138–48
- Biller BMK et al. Abstract OR16-2. Oral presentation at the
Endocrine Society Annual Congress 2019
- Nieman LK et al. Am J Med 2005;118:1340–6
- Signifor® and Signifor® LAR Summary of Product Characteristics,
June 2018
- Pivonello R et al. Lancet Diabetes Endocrinol
2016;4:611–29
- Nieman LK et al. J Clin Endocrinol Metab 2015;100:2807–31
- Isturisa® Summary of Product Characteristics. May 2020
- Isturisa® Prescribing Information. March 2020
About the Recordati group
Recordati, established in 1926,
is an international pharmaceutical group, listed on the Italian
Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT
0003828271), with a total staff of more than 4,300, dedicated to
the research, development, manufacturing and marketing of
pharmaceuticals. Headquartered in Milan, Italy, Recordati has
operations throughout the whole of Europe, including Russia,
Turkey, North Africa, the United States of America, Canada, Mexico,
some South American countries, Japan and Australia. An efficient
field force of medical representatives promotes a wide range of
innovative pharmaceuticals, both proprietary and under license, in
a number of therapeutic areas including a specialized business
dedicated to treatments for rare diseases. Recordati is a partner
of choice for new product licenses for its territories. Recordati
is committed to the research and development of new specialties
with a focus on treatments for rare diseases. Consolidated revenue
for 2019 was € 1,481.8 million, operating income was € 465.3
million and net income was € 368.9 million.
For further information:
Recordati website: www.recordati.com
Investor Relations
Media RelationsMarianne
Tatschke
Studio Noris
Morano(39)0248787393
(39)0276004736, (39)0276004745e-mail: investorelations@recordati.it
e-mail: norismorano@studionorismorano.com
Statements contained in this release, other than
historical facts, are "forward-looking statements" (as such term is
defined in the Private Securities Litigation Reform Act of 1995).
These statements are based on currently available information, on
current best estimates, and on assumptions believed to be
reasonable. This information, these estimates and assumptions may
prove to be incomplete or erroneous, and involve numerous risks and
uncertainties, beyond the Company’s control. Hence, actual results
may differ materially from those expressed or implied by such
forward-looking statements. All mentions and descriptions of
Recordati products are intended solely as information on the
general nature of the company’s activities and are not intended to
indicate the advisability of administering any product in any
particular instance.
- Isturisa_LINC 4_press release 5.0 (Corporate) (002)
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