Corcept’s Phase 3 Long-Term Extension Study of Relacorilant Demonstrated Durable Cardiometabolic Improvements in Patients with Hypercortisolism
Corcept Therapeutics (NASDAQ: CORT) presented results from its Phase 3 long-term extension study of relacorilant for treating hypercortisolism at WCIRDC. The study, involving 116 patients with treatment duration up to six years, demonstrated significant cardiometabolic improvements. At month 24, patients showed notable reductions in mean systolic blood pressure (10.0 mm Hg; p=0.012) and mean diastolic blood pressure (7.3 mm Hg; p=0.016).
The drug was well-tolerated, and patients maintained improvements in various cardiometabolic measures, including glycemic control and body weight. Patients who resumed relacorilant after receiving placebo showed both reversal of deterioration and additional improvement. The company plans to submit a new drug application (NDA) this month.
Corcept Therapeutics (NASDAQ: CORT) ha presentato i risultati del suo studio di estensione a lungo termine di fase 3 sul relacorilant per il trattamento dell'iperCortisolismo al WCIRDC. Lo studio, che ha coinvolto 116 pazienti con una durata del trattamento di fino a sei anni, ha dimostrato significativi miglioramenti cardiometabolici. Al termine del mese 24, i pazienti hanno mostrato riduzioni notevoli nella pressione arteriosa sistolica media (10,0 mm Hg; p=0,012) e nella pressione arteriosa diastolica media (7,3 mm Hg; p=0,016).
Il farmaco è stato ben tollerato e i pazienti hanno mantenuto miglioramenti in vari parametri cardiometabolici, tra cui il controllo glicemico e il peso corporeo. I pazienti che hanno ripreso il relacorilant dopo aver ricevuto un placebo hanno mostrato sia un'inversione del deterioramento che un ulteriore miglioramento. L'azienda prevede di presentare una nuova domanda di registrazione del farmaco (NDA) questo mese.
Corcept Therapeutics (NASDAQ: CORT) presentó los resultados de su estudio de extensión a largo plazo de fase 3 sobre relacorilant para el tratamiento del hipercortisolismo en el WCIRDC. El estudio, que incluyó 116 pacientes con una duración del tratamiento de hasta seis años, demostró mejoras cardiometabólicas significativas. En el mes 24, los pacientes mostraron reducciones notables en la presión arterial sistólica media (10.0 mm Hg; p=0.012) y en la presión arterial diastólica media (7.3 mm Hg; p=0.016).
El fármaco fue bien tolerado y los pacientes mantuvieron mejoras en varias medidas cardiometabólicas, incluyendo el control glucémico y el peso corporal. Los pacientes que reanudaron el relacorilant después de recibir un placebo mostraron tanto la reversión del deterioro como una mejora adicional. La empresa planea presentar una nueva solicitud de licencia de medicamento (NDA) este mes.
Corcept Therapeutics (NASDAQ: CORT)는 WCIRDC에서 고코르티솔혈증 치료를 위한 relacorilant의 3상 장기 연장 연구 결과를 발표했습니다. 6년까지 치료한 116명의 환자를 대상으로 한 이 연구에서는 심혈관 대사 개선이 크게 나타났습니다. 24개월 차에 환자들은 평균 수축기 혈압(10.0 mm Hg; p=0.012)과 평균 이완기 혈압(7.3 mm Hg; p=0.016)의 뚜렷한 감소를 보였습니다.
이 약물은 잘 견딜 수 있었습니다. 환자들은 혈당 조절과 체중을 포함한 다양한 심혈관 대사 지표에서 개선을 유지했습니다. 플라시보를 받은 후 relacorilant를 재개한 환자들은 퇴보의 역전과 추가 개선을 모두 보였습니다. 회사는 이번 달에 새로운 약물 허가 신청(NDA)을 제출할 계획입니다.
Corcept Therapeutics (NASDAQ: CORT) a présenté les résultats de son étude d'extension à long terme de phase 3 sur le relacorilant pour le traitement de l'hypercortisolisme lors du WCIRDC. L'étude, qui a impliqué 116 patients avec une durée de traitement allant jusqu'à six ans, a démontré des améliorations cardiométaboliques significatives. Au mois 24, les patients ont montré des réductions notables de la pression artérielle systolique moyenne (10,0 mm Hg; p=0,012) et de la pression artérielle diastolique moyenne (7,3 mm Hg; p=0,016).
Le médicament a été bien toléré et les patients ont maintenu des améliorations dans diverses mesures cardiométaboliques, y compris le contrôle glycémique et le poids corporel. Les patients qui ont repris le relacorilant après avoir reçu un placebo ont montré à la fois une inversion de la détérioration et une amélioration supplémentaire. La société prévoit de soumettre une nouvelle demande d'autorisation de médicament (NDA) ce mois-ci.
Corcept Therapeutics (NASDAQ: CORT) stellte die Ergebnisse seiner Phase-3-Studie zur langfristigen Behandlung von Hypercortisolismus mit Relacorilant auf dem WCIRDC vor. In der Studie, an der 116 Patienten teilnahmen und die bis zu sechs Jahre dauerte, wurden signifikante kardiometabolische Verbesserungen festgestellt. Nach 24 Monaten zeigten die Patienten bemerkenswerte Rückgänge des mittleren systolischen Blutdrucks (10,0 mm Hg; p=0,012) und des mittleren diastolischen Blutdrucks (7,3 mm Hg; p=0,016).
Das Medikament wurde gut vertragen und die Patienten behielten Verbesserungen in verschiedenen kardiometabolischen Messungen, einschließlich der glykämischen Kontrolle und des Körpergewichts, bei. Patienten, die nach einer Placebo-Behandlung zu Relacorilant zurückkehrten, zeigten sowohl eine Umkehr der Verschlechterung als auch zusätzliche Verbesserungen. Das Unternehmen plant, in diesem Monat einen neuen Antrag auf Zulassung eines Medikaments (NDA) einzureichen.
- Phase 3 long-term extension study showed significant blood pressure reductions at 24 months
- Demonstrated durable cardiometabolic improvements for up to 6 years
- Well-tolerated safety profile in long-term use
- NDA submission planned for the current month
- Positive efficacy in glycemic control and body weight maintenance
- None.
Insights
The Phase 3 long-term extension study results for relacorilant demonstrate compelling efficacy in treating hypercortisolism. The data shows statistically significant blood pressure reductions of
This clinical milestone significantly strengthens Corcept's market position in the hypercortisolism treatment space. The robust long-term data, showing both efficacy and safety over a six-year period, could translate into substantial market adoption upon approval. The demonstrated cardiometabolic improvements and better tolerability compared to current treatments suggest potential for relacorilant to become a first-line therapy, representing a significant revenue opportunity. With an NDA submission planned this month, CORT could see a major catalyst in 2024-2025. The stock's valuation could see positive momentum as the company approaches this regulatory milestone, particularly given the market cap of
- Results from Phase 3 long-term extension study of relacorilant to treat patients with hypercortisolism were presented at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
- 116 patients with hypercortisolism were enrolled with treatment duration of up to six years
- Results provide further evidence of relacorilant’s potential benefit as a treatment for patients with hypercortisolism
The Phase 3 long-term extension study enrolled 116 patients who had previously completed either Corcept’s Phase 3 GRACE or GRADIENT studies or its Phase 2 study in hypercortisolism. Patients experienced further improvement in blood pressure while maintaining response in other cardiometabolic measures, such as glycemic control and body weight. Consistent with its known safety profile, relacorilant was well-tolerated with a treatment duration of up to six years.
At month 24 of the study, patients exhibited clinically meaningful and statistically significant reductions in mean systolic blood pressure (10.0 mm Hg; p-value: 0.012) and mean diastolic blood pressure (7.3 mm Hg; p-value: 0.016), compared to their measurement at entry into the long-term extension study. Patients who resumed receiving relacorilant in the extension study, after being switched to placebo in the randomized-withdrawal phase of the GRACE study, experienced both a reversal of the deterioration they exhibited while receiving placebo and additional improvement beyond their blood pressure measurement at entry into the randomized portion of the study. To ensure accuracy, blood pressure was measured by 24-hour ambulatory blood pressure monitoring.
Dr. Richard Auchus, MD, PhD, Professor of Internal Medicine in the Division of Metabolism, Endocrinology & Diabetes at the University of
“People living with hypercortisolism are at risk of serious cardiometabolic comorbidities, including hypertension and hyperglycemia. These long-term data demonstrate significant improvements across a broad set of signs and symptoms of hypercortisolism without the toxicities observed with current treatment options. It is especially encouraging to see data from patients treated for up to six years that show progressive reductions in blood pressure, maintenance of cardiometabolic improvements, and long-term drug tolerability,” said Dr. Auchus.
“The positive results from the long-term extension study of relacorilant are consistent with findings from our GRACE, GRADIENT and Phase 2 studies. These data will support relacorilant’s new drug application (NDA), which we plan to submit this month,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Relacorilant’s strong efficacy and safety profile positions the medication to become a new standard of care in treating patients with hypercortisolism.”
The presentation at WCIRDC is available here.
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to endogenous hypercortisolism (Cushing’s syndrome), including ovarian, adrenal and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in
About Hypercortisolism (Cushing’s Syndrome)
Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include statements concerning: relacorilant, including its clinical attributes and potential to receive regulatory approval and become a standard-of-care treatment for patients with endogenous hypercortisolism or any other disorder; regulatory oversight of relacorilant and the scope, pace and outcome of its NDA submission; relacorilant’s acceptance and use by physicians and patients and its commercial prospects; and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
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