Slide 1: OASIS-1 and -2 responder analysis
OASIS-1 and –2 responder analysis June 29, 2024 Nick Panay1*, James Simon2, Claudio N. Soares3, Cecilia Caetano4, Claudia Haberland5; Nazanin Haseli-Mashhadi6, Ulrike Krahn8, Susanne Parke5, Christian Seitz5,7, Lineke Zuurman5 1. Queen Charlotte's & Chelsea Hospital, Imperial College, London, UK; 2.
Slide 2: Disclosures
Disclosures These studies were sponsored by Bayer. Nick Panay has lectured and acted in an advisory capacity for: Abbott, Astellas, Bayer, Besins, Gedeon Richter, Mithra, Novo Nordisk, SeCur, Theramex and Viatris. James Simon has grant/research support from: AbbVie, Inc., Bayer Healthcare LLC., Daré
Slide 3: Study overview
STUDY OVERVIEW Study overview Elinzanetant is a dual NK-1,3 receptor antagonist in development for the treatment of moderate-to-severe VMS associated with menopause OASIS 1 and 2 were Participants Sites pivotal Phase 3 studies Postmenopausal* assessing the efficacy and Sites across the women aged sa
Slide 4: OASIS 1 & 2: Study design
OASIS-1 OASIS 1 & 2: STUDY DESIGNand -2: Study design OASIS 1: N=199 OASIS 2: Elinzanetant 120 mg Elinzanetant 120 mg N=200 OASIS 1: Follow up Randomization N=197 Placebo Elinzanetant 120 mg (4 weeks) OASIS 2: N=200 12 weeks 14 weeks
Slide 5: Participant demographics
Participant demographics Race Age (years) OASIS 1 OASIS 2 OASIS 1 78.2% White 86.0% 54.6 54.5 75.9% 81.5% OASIS 2 Black or 19.3% African 12.5% 54.8 54.4 19.1% 17.5% American 8.5% Hispanic or 6.5% BMI (kg/m2) 7.1% Latina 12.0% OASIS 1 2.5% 1.5% 27.8 27.7 Other 1.0% 5.0% OASIS 2 0% 50% 100% 100% 50% 0
Slide 6: Elinzanetant achieved statistical significance on all tested endpoints in both studies
Elinzanetant achieved statistical significance on all tested endpoints in both studies OASIS 2 OASIS 1 Endpoint Outcome p-value p-value Hot flashes frequency Week 4 <0.0001 <0.0001 Elinzanetant superior Primary Hot flashes frequency Week 12 <0.0001 <0.0001 Elinzanetant superior Hot flashes sever
Slide 7: Mean change from baseline in frequency of moderate/severe VMS over time
Mean change from baseline in frequency of moderate/severe VMS over time OASIS 1 OASIS 2 Elinzanetant 120 mg Placebo Elinzanetant 120 mg Placebo n 199 197 n 199 200 Baseline, mean (SD) 13.38 (6.57) 14.26 (13.94) Baseline, mean (SD) 14.66 (11.08) 16.16 (11.15) Double-blind phase Elinzanetant phase Dou
Slide 8: Proportion of participants experiencing a reduction ≥50% in VMS frequency at weeks 4, 12, and 26
Proportion of participants experiencing a reduction ≥50% in mean daily frequency of moderate to severe VMS at weeks 4, 12, and 26 (treatment response) OASIS 1 100% OASIS 2 84.5% 86.7% a reduction ≥50% in Proportion of participants experiencing a reduction ≥50% in 90% 90% 81.6% 81.5% mean daily frequ
Slide 9: Overview of TEAEs: weeks 1-12
Overview of TEAEs: weeks 1-12 N (%) OASIS 1 OASIS 2 EZN 120 mg PBO EZN 120 mg PBO week 1-12 week 1-12 week 1-12 week 1-12 (N=199) (N=194) (N=201) (N=199) Any TEAE 102 (51.3%) 94 (48.5%) 89 (44.3%) 76 (38.2%) Study drug- 43 (21.6%) 28 (14.4%) 40 (19.9%) 18 (9.0%) related TEAE AE leading to 17 (8.5%)
Slide 10: Most frequent TEAEs: weeks 1-12
Most frequent TEAEs: weeks 1-12 N (%) OASIS 1 OASIS 2 EZN 120 mg PBO EZN 120 mg PBO week 1-12 week 1-12 week 1-12 week 1-12 (N=199) (N=194) (N=201) (N=199) Headache 14 (7.0%) 5 (2.6%) 18 (9.0%) 5 (2.5%) Fatigue 14 (7.0%) 3 (1.5%) 11 (5.5%) 3 (1.5%) Arthralgia 10 (5.0%) 10 (5.2%) 5 (2.5%) 2 (1.0%) EZ
Slide 11: OASIS 1 & 2: Responder summary
OASIS 1 & 2: Responder summary • In the OASIS 1 and 2 studies, elinzanetant showed a statistically and clinical meaningful reduction in the frequency of moderate to severe VMS, with quick onset and sustained effect over time. • In OASIS 1 and 2, 71% and 75% of elinzanetant-treated women experienced
Slide 12: Questions?
Questions? 12