Biophytis Sa · EURONEXT:ALBPS
Biophytis Sa — American Thoracic Society 2023
13 slides from Biophytis Sa's conference presentation, May 24, 2023
Slide 1: COVA study: results from a double-blind, placebo-controlled phase 2/3 study of BIO101
BIOPHYTIS, PARIS, FRANCE COVA study: results from a double-blind, American Thoracic Society 2023 placebo-controlled phase 2/3 study to assess efficacy and safety of BIO101 in hospitalized COVID-19 patients Dr. G. Nair, 19-24 May, 2023 | Washington, USA Beaumont Hospital Interstitial Lung Disease Cli
Slide 2: Author affiliations and funding source
Author affiliations and funding source Affiliation Author William Beaumont University Hospital G. Nair Royal Oak, MI, US Hospital de Base Da Faculdade de Medicina S. Lobo São José Do Rio Preto, BR Biophytis W. Dioh, C. Tourette, S. Rabut, S. Camelo, L. E. Sorbonne Université, BC9, 4 place Jussieu, E
Slide 3: BIO101 Mechanism of action
BIO101 Mechanism of action SARS-CoV-2 x Harmful or classical arm of RAS Protective arm of RAS ACE2 Ang I Ang-(1-9) ACE • BIO101 activates Mas receptor on ACE the protective arm of RAS Ang II x ACE2 Ang-(1-7) • Protection against respiratory function deterioration (lungs and respiratory muscles) SARS
Slide 4: Study design: phase 2/3, double-blind, placebo-controlled, group-sequential and adaptive study
Study design: phase 2/3, double-blind, placebo-controlled, group-sequential and adaptive study • BIO101 350 mg BID vs placebo, randomization 1:1 • Key inclusion criteria: • Age 45 and older • Proven Covid-19 infection • Hospitalized with or without supplemental oxygen (low-flow, CPAP/BiPAP, HFO*) •
Slide 5: Endpoints
Endpoints Primary, time frame – up to 28 days: Key secondary, time Secondary: frame – up to 28 days: Proportion of participants with • Proportion of ‘negative’ events: Proportion of participants participants with o All-cause mortality or with ‘positive’ events ie. events of all-cause o Respiratory f
Slide 6: Baseline Characteristics, Intention to Treat (ITT) analysis set
Baseline Characteristics, Intention to Treat (ITT) analysis set BIO101 (N=126) PLB (N=107) Total (N=233) Age (years), Mean (SD) 63.0 (9.82) 62.5 (8.46) 62.8 (9.21) Age range (min-max) 40 - 90 40 - 90 40 - 90 Age categories, n (%) < 65 years 69 (54.8) 62 (57.9) 131 (56.2) ≥ 65 years 57 (45.2 45 (42.1
Slide 7: BIO101 reduced the proportion of patients with respiratory failure or early death
BIO101 reduced the proportion of patients with respiratory failure or early death Primary endpoint Comparison of BIO101 350 mg BID vs PLB CMH test (ITT) Adjusted BIO101 (N=126) PLB (N=107) Unadjusted Difference (%) P-value n (%) n (%) Difference (%) (95% CI) 19.85 (15.8) 27.86 (26.0) -10.3 -11.4 (-2
Slide 8: Reduction in the risk of early death and respiratory failure by 44% at 28 days
Reduction in the risk of early death and respiratory failure by 44% at 28 days in BIO101 group Log-rank test, ITT Analysis set • BIO101 group shows a relative reduction of risk of early death and respiratory failure by 44% • Hazard Ratio (95% CI): 0.489 (0.265, 0.904) • Log-rank test p = 0.0223 Stra
Slide 9: Higher proportion of patients recovered and discharged
Higher proportion of patients recovered and discharged BIO101 Placebo Unadjusted Adjusted 350mg B.I.D. (N=107) Difference Difference (%) P-value (N=126) (95% CI) n (%) n (%) (%) Combined 100.94 (80.1) 75.91 (70.9) 9.2 11.0 (-0.4, 22.4) 0.0586 Inference • BIO101 group had numerically higher proportio
Slide 10: Relative reduction in risk of death observed of 43% in BIO101 group at 90 days
Relative reduction in risk of death observed of 43% in BIO101 group at 90 days • BIO101 group shows a relative reduction of risk of death by 43% • Hazard Ratio (95% CI) 0.554 (0.285, 1.077), p = 0.0829 Stratification factors: RAS pathway modulator use, gender, co-morbidities and receiving CPAP/BiPAP
Slide 11: Adverse Events Overview: BIO101 demonstrates a very good safety profile
Adverse Events Overview: BIO101 demonstrates a very good safety profile Safety Analysis Set • A lower proportion of patients experienced TEAEs in the Treatment emergent adverse events (TEAE) BIO101 than in the placebo group (57% vs 64.4%) • The most frequent serious TEAEs were respiratory failure, B
Slide 12: Conclusions
Conclusions • Primary endpoint: BIO101 reduced proportion of patients with respiratory failure or early death at day 28 (p=0.043). Relative reduction in risk of 44% • Key secondary endpoint: strong trend towards higher proportion of recovered and discharged patients at day 28 in BIO101 group (p= 0.0
Slide 13: Acknowledgements
Acknowledgements COVA Steering Committee Prof. C. Morelot; Dr. M. Lins; Prof. G. Nair; Dr. G. Plantefève; Dr. T. Whitehouse COVA Data Monitoring Commmittee Dr. F. Baharloo; Dr. A. Lemaingen, Dr. D. de Ziegler, Dr. S. Michiels Richard Kay: statistical advice 13