New data on aprocitentan will be presented during ASN Kidney Week 2024 | 16/10/24

Allschwil, Switzerland – October 16, 2024

Idorsia Ltd (SIX: IDIA) today announced that new data on Idorsia’s endothelin receptor antagonist aprocitentan will be presented at American Society of Nephrology (ASN) Nephrology Week 2024, to be held in San Diego, California, October 23-27 2024 .

The following oral and poster presentations will be held highlighting the promising results of aprocitentan in patients with hypertension not adequately controlled with other medications, with positive effects on blood pressure and proteinuria measurements, in patients with concomitant chronic kidney disease (CKD) . stages 3 and 4 and a favorable tolerability profile, including no deterioration of renal function or hyperkalemia.

  • Bakris GL et al. “Aprocitentan in patients with chronic kidney disease (CKD): subgroup analysis of the PRECISION trial“, oral presentation Markus Schlaich, abstract no.: FR-OR48, session “Hypertension, CVD and kidneys: clinical trials (OR1602), room 5 (Congress Centre), October 25, 16:50 – 17:00.
  • Bakris GL et al. “Incidence and incidence of edema and the impact of aprocitentan treatment strategy in the PRECISION study“, poster presentation Markus Schlaich, poster no. SA-PO356, Exhibit Halls AC, October 26, 10:00 – 12:00.

Idorsia US will also be present at ASN Kidney Week with the TRYVIO (aprocitentan) commercial and medical stand. Visit the team at booth #1705.

Additionally, data from Idorsia’s Phase 3 program for lucerastat, a glucosylceramide synthase inhibitor, will be presented in poster format:

  • Wallace EL et al. “Effect of Lucerastat on renal function in patients with Fabry disease: Results of a phase 3 clinical program“, poster presentation by Eric Wallace, poster no. SA-PO654, Exhibit Halls AC, October 26, 10:00 – 12:00.

Abstracts will be published in the Journal of the American Society of Nephrology and can be found in the journal ASN Kidney Week Summary Supplement.

Notes for the editor

About aprocitentan
Aprocitentan is a once-daily, oral, dual endothelin receptor antagonist from Idorsia that inhibits ET-1 binding to ETAND and E.TB receptors. In May 2022, Idorsia announced positive primary results from the Phase 3 PRECISION trial using aprocitentan in the treatment of patients with resistant hypertension. Detailed results were published in Lancet and presented in the form of a Late-Breaking Science presentation during the American Heart Association (AHA) scientific sessions in November 2022. More details and comments can be found in the special press release and in the webcast for investors with the participation of prof. Markus Schlaich, researcher at PRECISION. On March 19, 2024, aprocitentan was approved in the US as TRYVIO™. On June 27, 2024, the European Commission issued a marketing authorization for JERAYGO™ (aprocitentan).

About lucerastat
Lucerastat is an oral glucosylceramide synthase inhibitor from Idorsia, offering a potentially new approach to the treatment of all Fabry disease patients, regardless of the type of GLA gene mutation. In October 2021, the company reported that Lucerastat 1,000 mg twice daily did not meet its primary endpoint of reducing neuropathic pain during 6 months of treatment compared to placebo. However, Lucerastat showed a significant reduction in the plasma levels of the Fabry disease biomarker, Gb3, during the treatment period, with an approximately 50% decrease in plasma Gb3 observed in the lucerastat group compared with an increase of 12% in the placebo group. Additionally, the results suggest an effect of treatment on renal function. Lucerastat was well tolerated. Analysis of the ongoing phase 3 open-label extension (OLE) study confirmed long-term effects on plasma Gb3 levels and a potential positive long-term effect on renal function. The analysis also showed a safety and tolerability profile consistent with that observed during the 6-month randomized treatment period. The company is conducting an additional renal biopsy study in a subset of patients currently enrolled in the OLE study to guide further development of Fabry disease. In parallel, Idorsia is working with regulators to design another Phase 3 study to evaluate the effects of lucerastat on kidney function.

About Idorsia
Idorsia Ltd reaches for more – We have more ideas, we see more possibilities and we want to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company with a strong scientific background.

Headquartered near Basel, Switzerland – a European biotechnology hub – Idorsia specializes in the discovery, development and commercialization of small molecules with the goal of changing the horizon of therapeutic options. Idorsia boasts 25 years of experience in drug discovery, a broad portfolio of innovative medicines in the pipeline, an experienced team of specialists in all fields from laboratory research to point-of-care, as well as commercial activities in Europe and North America – an ideal constellation for introducing innovative medicines patients.

Idorsia was listed on the Swiss stock exchange SIX (ticker symbol: IDIA) in June 2017 and employs over 750 highly qualified specialists committed to achieving our ambitious goals.

For further information please contact us
Andrew C. Weiss
Senior Vice President, Director of Investor Relations and Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
[email protected]
[email protected]
www.idorsia.com

The above information contains certain “forward-looking statements” relating to the company’s business that can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected”, “will”, “will continue”, “should”, “would”, “seeks”, “expects” or “anticipates” or similar expressions, or through discussions of strategy, plans or intentions. Such statements include a description of the company’s investment and research and development programs and expected expenditures related thereto, a description of the new products anticipated by the company and the anticipated customer demand for these products and products in the company’s existing portfolio. Such statements reflect the company’s current views regarding future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. If one or more of these risks or uncertainties materialize or if the underlying assumptions prove incorrect, actual results may differ materially from those described herein as anticipated, expected, estimated or expected.

New data on aprocitentan will be presented during ASN Kidney Week 2024 | 16/10/24

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