Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease
17 Juin 2020 - 9:58AM
Business Wire
ISTURISA® (osilodrostat) demonstrates significant and
sustained benefit over placebo at normalizing mean urinary free
cortisol (mUFC) levels in patients with Cushing’s disease
Recordati Rare Diseases 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 upon
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.
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 inhibitor of 11β-hydroxylase
(CYP11B1), the enzyme responsible for the final step of cortisol
synthesis in the adrenal gland. Isturisa® will be available as
1-mg, 5-mg and 10-mg film-coated tablets. Isturisa®, indicated for
the treatment of adult patients with endogenous Cushing’s syndrome
(CS), is now available in France as the first EU country to launch.
Isturisa® was granted marketing authorization by the European
Commission (EC) on 9 January 2020. Please see prescribing
information for detailed recommendations for the use of this
product.8
References
- 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
- 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
About Recordati Rare Diseases
The company’s EMEA headquarters is located in Puteaux, France,
with global headquarter offices located in Milan, Italy.
For a full list of products, please click here:
www.recordatirarediseases.com/products.
For additional information, please visit our websites:
www.recordati.com and https://www.recordatirarediseases.com/ or
follow us on LinkedIn or Twitter for company updates.
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.
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Company Contact Gordon J
Daniels Head of International Marketing Telephone: +33 (0)607531337
e-mail: daniels.g@recordati.com
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