Corcept Therapeutics Incorporated · NASDAQ:CORT
Corcept Therapeutics — ENCALS 2025
13 slides from Corcept Therapeutics's conference presentation, Dec 15, 2025
Slide 1: A Phase 2 Trial of Dazucorilant in Amyotrophic Lateral Sclerosis
: A Phase 2, Randomized, Double- Blind, Placebo-Controlled Trial of Dazucorilant, a Selective Glucocorticoid Receptor Modulator, in Amyotrophic Lateral Sclerosis Leonard H. van den Berg,1 Jakub Antczak,2 Javier Mascias,3 Mariusz Grudniak,4 Pawel Lisewski,5 Philip Van Damme,6 Susanne Petri,7 Annekath
Slide 2: Disclosures
Disclosures • Leonard H. van den Berg discloses consultancy for Novartis, Sanofi, Takeda, Calico, Denali, Amylyx, Ferrer, VectorY, and Corcept.
Slide 3: DAZALS | Key Takeaways
DAZALS | Key Takeaways Glucocorticoid receptor modulation may benefit people with ALS by reducing the neurotoxic effects of excess cortisol activity1-3 Dazucorilant (DAZU) is an oral, selective glucocorticoid receptor modulator that competes with cortisol and reversibly binds to the glucocorticoid rec
Slide 4: A Phase 2 Study of Dazucorilant in ALS
A Phase 2 Study of Dazucorilant in ALS NCT05407324; EudraCT: 2021-005611-31 Population Adults ≥18 years of age with sporadic or familial ALS per Gold Coast criteria Stable doses of approved therapies were allowed Able to swallow capsules Not currently using glucocorticoids and no history of
Slide 5: DAZALS | Patient Disposition
DAZALS | Patient Disposition 249 participants randomized DAZU 300 mg DAZU 150 mg Placebo Double-Blind Period (24 weeks) N=83 N=84 N=82 Primary Endpoint Entered OLE Dazucorilant 300 mg N=13 N=40 N=64 Data cutoff: 25Nov2024 Abbreviations: DAZU, dazucorilant; OLE, open label extension. 5
Slide 6: Baseline Characteristics Were Well Balanced
DAZALS | Baseline Characteristics Were Well Balanced DAZU 300 mg DAZU 150 mg Placebo N=83 N=84 N=82 Age, mean 58 years 58 years 60 years Gender Male 59.0% 59.5% 63.4% Region Europe 94.0% 89.3% 92.7% North America 6.0% 10.7% 7.3% Site of onset Bulbar 16.9% 14.3% 14.6% ENCALS risk score, mean -4.36 -4
Slide 7: ALSFRS-R and Survival (Double-Blind Period)
DAZALS | ALSFRS-R and Survival (Double-Blind Period) The primary objective of slowing functional decline on the ALSFRS-R scale was not met 0 LSM (95% CI) Change in ALSFRS-R Total Score -2 Change -4 from Baseline Placebo -6.8 -6 DAZU DAZU 300 mg 150 mg DAZU -7.0 LSM vs PBO -0.7 -0.3 150 mg -8 (95% CI
Slide 8: Exploratory Overall Survival Analysis
DAZALS | Exploratory Overall Survival Analysis Comparing patients who received DAZU 300 mg only vs Placebo only* DAZU 300 mg Placebo only* N=83 N=18 Deaths, n (%) 14 (17) 7 (39) Median OS, wk (95% CI) 75 (67, NE) 48 (21, NE) HR (95% CI) 0.16 (0.06, 0.41) P-value, log-rank test 0.0009 Patients who re
Slide 9: Exploratory Overall Survival Analysis
DAZALS | Exploratory Overall Survival Analysis Prolonged treatment with DAZU 300 mg was associated with longer survival* >24 wks 24 wks DAZU DAZU 300 mg 150 mg or placebo* N=51 N=28 Deaths, n (%) 7 (14) 10 (36) HR (95% CI) 0.36 (0.14, 0.97) P-value, log-rank test 0.02 Patients who were treated with
Slide 10: Safety Summary for the Double-Blind Period
DAZALS | Safety Summary for the Double-Blind Period DAZU 300 mg DAZU 150 mg Placebo N=83 N=83 N=82 Patients with at least one TEAE 98.8% 96.4% 75.6% TEAE leading to dose interruption 41.0% 36.1% 9.8% TEAE leading to treatment discontinuation 57.8% 30.1% 8.5% Patients with at least one severe TEAE 20
Slide 11: Abdominal Pain in the Double-Blind Period
DAZALS | Abdominal Pain in the Double-Blind Period Tolerability | Abdominal pain was the most frequently reported adverse event Onset occurred during the first 3–5 weeks and resolved following interruption or discontinuation Patients who continued DAZU after reporting abdominal pain had resolution w
Slide 12: Conclusions
DAZALS | Conclusions No Impact to DAZALS did not achieve its primary endpoint of slowing functional decline as measured by the 1 ALSFRS-R ALSFRS-R scale Survival 2 Improved by Secondary and exploratory endpoints showed improvement in overall survival for patients who received DAZU 300 mg, including
Slide 13: Acknowledgements
DAZALS | Acknowledgements Thank you to all the patients, caregivers, family members, investigators, and site staff who supported this global trial. Jakub Antczak Mariusz Grudniak Thomas Lambert Pawel Lisewski Leonard van den Berg Magdalena Kuzma- Orla Hardiman Kozakiewicz Marvin Chum Angela Genge 1