Business Wire

RECORDATI-RARE-DISEASES

Share
Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in 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

  1. Bertagna X et al. J Clin Endocrinol Metab 2014;99:1375–83
  2. Fleseriu M et al. Pituitary 2016;19:138–48
  3. Biller BMK et al. Abstract OR16-2. Oral presentation at the Endocrine Society Annual Congress 2019
  4. Nieman LK et al. Am J Med 2005;118:1340
  5. Signifor® and Signifor® LAR Summary of Product Characteristics, June 2018
  6. Pivonello R et al. Lancet Diabetes Endocrinol 2016;4:611–29
  7. Nieman LK et al. J Clin Endocrinol Metab 2015;100:2807–31
  8. 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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Access Advance Welcomes Global Technology Leaders as Licensees and Licensors to New Video Distribution Patent Pool2.7.2025 02:00:00 CEST | Press release

Access Advance LLC ("Advance") today announced the inaugural roster of licensees and licensors for its Video Distribution Patent ("VDP") Pool, marking a significant milestone in the program's rapid market adoption since its January announcement. The participation of major global companies heavily involved in video codec technology demonstrates strong industry support for the comprehensive licensing solution covering HEVC, VVC, VP9, and AV1 codecs. The VDP Pool has successfully attracted a group of licensees/licensors including ByteDance, Kuaishou, NTT Docomo, and Tencent. This represents the beginning of what Access Advance expects to be widespread adoption among content streaming providers seeking simplified codec licensing. The licensees’ participation provides immediate access to the wide-ranging patent portfolio while benefiting from the fixed tiered pricing structure designed to scale with business size. "We're pleased to welcome ByteDance, Kuaishou, NTT Docomo and Tencent as our

Intralot S.A. to Acquire Bally’s International Interactive Business in a Transaction that Creates a Global Gaming Technology and Services Company in Lottery and Digital Online Gaming Markets1.7.2025 21:10:00 CEST | Press release

Intralot S.A. to Remain Listed on the Athens Stock ExchangeTransaction Enterprise Value of €2.7 Billion Intralot S.A. (ATSE: INLOT) (“Intralot”) and Bally’s Corporation (NYSE: BALY) (“Bally’s”) today announced that their respective Boards of Directors approved their entry into a definitive transaction agreement (“Transaction Agreement”) pursuant to which Intralot will acquire Bally’s International Interactive business (the “International Interactive Business”) in a cash-and-shares transaction that values the International Interactive Business at an enterprise value of €2.7 billion (the “Transaction”). The consideration for the acquisition of the International Interactive Business will comprise a combination of cash paid by Intralot and newly issued shares delivered by Intralot to Bally’s, as more specifically detailed below. As part of the Transaction, Intralot expects to refinance part of its existing debt facilities and Bally’s also expects to repay secured debt from the cash proceed

Valeo Foods Group Acquires Melegatti Cakes Expanding the Italian Bakery Portfolio1.7.2025 18:21:00 CEST | Press release

Valeo Foods Group, one of Europe’s leading producers of quality sweets, treats and snacks, has successfully acquired the assets of an Italian panettone, pandoro and croissant producer, Melegatti 1894 S.p.A.This acquisition is another step forward in Valeo Foods Groups’ strategy to expand its baked sweet treats portfolio, and reinforces Valeo’s commitment to bringing authentic Italian confections and established regional brands to a wider international audience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702677156/en/ Melegatti Founded in 1894 in Verona, Melegatti has a strong reputation for artisanal cakes - particularly pandoro, panettone and filled croissants - traditional recipes, and a rich Italian heritage, Melegatti has a proud legacy founded on family values, craftsmanship, and a passion for quality. “We are excited to welcome Melegatti into the Valeo Foods Group,” said Ronald Kers, Group CEO. “This acquisition

PUMA and Borussia Dortmund Extend Partnership1.7.2025 18:18:00 CEST | Press release

Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701775493/en/ Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. Since the start of their partnership in the 2012/13 season, BVB has celebrated many successes, such as reaching the finals of the 2012/13 and 2023/24 UEFA Champions League and winning the 2016/17 and 2020/21 German DFB Cup. The club is currently participating in the FIFA Club World Cup, where it has already reached the round of 16. BVB continues to set the standard in European football w

Gogo Galileo HDX Coming to Cessna Citation Jet Models1.7.2025 17:00:00 CEST | Press release

Expected FAA Supplemental Type Certification in late 2025 Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. The global Low Earth Orbit (LEO) solution allows customers to enjoy one of the best possible in-flight connectivity and aviation experiences, no matter where their journey takes them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701750049/en/ Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. (Photo: Textron Aviation) By offering Gogo Galileo HDX as an aftermarket upgrade, the Textron Av

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye