MENLO PARK, CA, USA I November 19, 2018 I Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today announced that it dosed the first patient in the Phase 3 trial of relacorilant to treat patients with Cushing’s syndrome.
“We are excited to enroll the first patient in relacorilant’s Phase 3 trial,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Patients in Phase 2 experienced significant clinical benefit without Korlym’s serious off-target effects – endometrial thickening, vaginal bleeding and hypokalemia. Confirming these results in Phase 3 would constitute a major medical advance.”
“I also want to thank our development team, and especially our Chief Medical Officer, Dr. Robert S. Fishman, for their tireless efforts in advancing relacorilant and our other product candidates,” said Dr. Belanoff. “Our clinical programs are poised to make significant progress in a wide variety of serious disorders – Cushing’s syndrome, pancreatic, ovarian and prostate cancer, non-alcoholic steato-hepatitis (NASH) and antipsychotic-induced weight gain. Patients with these serious disorders have few good options. If we are successful in developing treatments for them, it will be in no small part because of Bob’s insight, and hard work.” As announced earlier today, Dr. Fishman, will be stepping down from his position as Corcept’s Chief Medical Officer, effective January 31st, 2019.
The Phase 3 trial (entitled “GRACE”) is expected to enroll 130 patients with Cushing’s syndrome at sites in the United States, Canada and Europe. The trial has a two-phase design. In the initial, open-label portion, all patients will receive relacorilant for 22 weeks, with doses starting at 100 mg per day, then increasing in 100 mg increments, as clinically indicated, to a maximum of 400 mg per day. After 22 weeks, patients who exhibit pre-specified improvements in glucose tolerance or hypertension – two of Cushing’s syndrome’s most common and pernicious symptoms – will enter a double-blind, placebo-controlled, withdrawal phase lasting 12 weeks. Half of the patients entering this phase will continue to receive relacorilant. The rest will receive placebo. The rate and degree of relapse in patients receiving placebo will be measured against the same parameters in patients continuing relacorilant.
The FDA has designated relacorilant an orphan drug for the treatment of patients with Cushing’s syndrome. Corcept has been issued patents covering relacorilant’s composition of matter and method of use that expire in 2033.
Cushing’s Syndrome
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® is the company’s first FDA-approved medication. We have discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol but not progesterone. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators, including Korlym, to treat a wide variety of serious disorders.
SOURCE: Corcept Therapeutics
Post Views: 36
MENLO PARK, CA, USA I November 19, 2018 I Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today announced that it dosed the first patient in the Phase 3 trial of relacorilant to treat patients with Cushing’s syndrome.
“We are excited to enroll the first patient in relacorilant’s Phase 3 trial,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Patients in Phase 2 experienced significant clinical benefit without Korlym’s serious off-target effects – endometrial thickening, vaginal bleeding and hypokalemia. Confirming these results in Phase 3 would constitute a major medical advance.”
“I also want to thank our development team, and especially our Chief Medical Officer, Dr. Robert S. Fishman, for their tireless efforts in advancing relacorilant and our other product candidates,” said Dr. Belanoff. “Our clinical programs are poised to make significant progress in a wide variety of serious disorders – Cushing’s syndrome, pancreatic, ovarian and prostate cancer, non-alcoholic steato-hepatitis (NASH) and antipsychotic-induced weight gain. Patients with these serious disorders have few good options. If we are successful in developing treatments for them, it will be in no small part because of Bob’s insight, and hard work.” As announced earlier today, Dr. Fishman, will be stepping down from his position as Corcept’s Chief Medical Officer, effective January 31st, 2019.
The Phase 3 trial (entitled “GRACE”) is expected to enroll 130 patients with Cushing’s syndrome at sites in the United States, Canada and Europe. The trial has a two-phase design. In the initial, open-label portion, all patients will receive relacorilant for 22 weeks, with doses starting at 100 mg per day, then increasing in 100 mg increments, as clinically indicated, to a maximum of 400 mg per day. After 22 weeks, patients who exhibit pre-specified improvements in glucose tolerance or hypertension – two of Cushing’s syndrome’s most common and pernicious symptoms – will enter a double-blind, placebo-controlled, withdrawal phase lasting 12 weeks. Half of the patients entering this phase will continue to receive relacorilant. The rest will receive placebo. The rate and degree of relapse in patients receiving placebo will be measured against the same parameters in patients continuing relacorilant.
The FDA has designated relacorilant an orphan drug for the treatment of patients with Cushing’s syndrome. Corcept has been issued patents covering relacorilant’s composition of matter and method of use that expire in 2033.
Cushing’s Syndrome
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® is the company’s first FDA-approved medication. We have discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol but not progesterone. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators, including Korlym, to treat a wide variety of serious disorders.
SOURCE: Corcept Therapeutics
Post Views: 36
