Biophytis Sa · EURONEXT:ALBPS
Biophytis Sa — ICFSR 2018 Miami
23 slides from Biophytis Sa's conference presentation, March 2018
Slide 1: Biophytis: The biotech specialist in aging diseases
biophytis NEW THERAPEUTICS FOR AGING DISEASES THE BIOTECH SPECIALIST IN AGING DISEASES
Slide 2: SARA-OBS, an observational study to characterize age related sarcopenia population
SARA-OBS, an observational study dedicated to characterize age related sarcopenia population suitable for interventional studies ICFSR 2018 Miami 1-3 March 2018 Waly Dioh, PhD Clinical Development Director
Slide 3: ICFSR 2018 Miami CONFIDENTIAL
ICFSR 2018 Miami CONFIDENTIAL 3
Slide 4: About Sarconeos (BIO101)
About Sarconeos (BIO101) • BIO101 is an investigational drug containing the active substance 20-hydroxyecdysone (20E) at 97%. • 20E is a triterpene, member of the phytoecdysones family. • BIO101 is manufactured through multiple steps of purifications, from the edible plant Stemmacantha Carthamoides.
Slide 5: Mechanism of action: Mas receptor activation
Mechanism of action: Mas receptor activation Plasma membrane receptor – GPCR receptor o 7 hydrophobic trans-membrane domains o Endogenous MAS ligand: Angiotensin-(1-7) o Selectively inhibited by A779 o Activation of AKT/mTOR pathway → BIO101 inhibits myostatin gene expression in a dose-dependent man
Slide 6: Sarconeos (BIO101) effects in vitro and in vivo
Sarconeos (BIO101) effects in vitro and in vivo SARCONEOS (BIO101) demonstrates SARCONEOS (BIO101) compensates effect hypertrophic effects of human muscle fiber of ageing on muscle functionality and on and activates protein synthesis mobility; stimulates anabolism in muscles Human Fusion index Fusio
Slide 7: The SARA Clinical Program
The SARA Clinical Program SARA: SARcopenia and sarcopenic obesity in patients Aged ≥ 65 years SARA clinical program is based on three main studies: v SARA-PK, the completed Phase 1 study that showed safety and pharmacokinetic profiles of BIO101 in older adults and allowed the selection of doses for
Slide 8: SARA-PK: Phase 1 Clinical Trial
SARA-PK: Phase 1 Clinical Trial First-In-Human, Randomized, double-blind, placebo-controlled, dose-escalation 1400 mg fasted Age ≥ 65 years 450 mg 700 mg bid fed 18≤ age ≤55 years fasted 700 mg fed 350 mg Older adults : 1400 mg bid fed 350 mg fasted fasted 350 mg qd 100 mg Age ≥ 65 years fed fasted
Slide 9: SARA-PK: Plasma concentration
SARA-PK: Phase 1 Clinical Trial BIO101 plasma concentration increased with the dose 700 • Cmax and AUCs increased, but less 600 Treatments than dose-proportionally. 100 mg fasted Plasma concentration (ng/mL) 500 350 mg fasted • Slight plasma accumulation after b.i.d 700 mg fasted 1400 mg fasted admi
Slide 10: SARA-OBS
SARA-OBS Characterising SARcopenia and sarcopenic obesity in patients Aged 65 years and over, at risk of mobility disability. An OBServational Clinical Trial (SARA-OBS) ICFSR 2018 Miami CONFIDENTIAL 10
Slide 11: SARA-OBS Main Objectives
SARA-OBS Main Objectives • To characterise sarcopenia, including sarcopenic obesity, in older patients (>65 years) living in the community and at risk of mobility disability • Evaluate their physical performance and body composition in view of the design of a phase 2 interventional study on the effi
Slide 12: Diagnosis and criteria for inclusion
Diagnosis and criteria for inclusion Sarcopenia according to FNIH criteria and SPPB 1. Men and women aged ≥ 65 years, living in the community, and reporting loss of physical function 2. Short Physical Performance Battery (SPPB) score ≤ 8 3. ALM/BMI < 0.789 in men and 0.512 in women, or ALM <19.75 kg
Slide 13: ICFSR 2018 Miami CONFIDENTIAL
ICFSR 2018 Miami CONFIDENTIAL 13
Slide 14: SARA-OBS Endpoints
SARA-OBS Endpoints • Primary Endpoint: Gait speed at the 400m Walking Test (400MW). • Co-Primary Endpoints: The Physical Function Domain (PF-10) of the Short Form Health Survey (SF-36). • Key secondary endpoint: Raising from a chair (at the SPPB). • Other Secondary Endpoints: – Handgrip or knee exte
Slide 15: SARA-OBS Enrollment Status
SARA-OBS Enrollment Status Country Prescreened Eligible to screen Screened Included Screened vs Prescreened Screened failure USA 869 395 326 36 37% 89% EUROPE 318 182 159 45 50% 72% Total 1187 577 485 81 41% 83% • 59% of the prescreened patients are not retained. • Absence of mobility issues and con
Slide 16: SARA-OBS Baseline characteristics
SARA-OBS Baseline characteristics • Demographics & Body composition Variable Mean Standard Deviation Age 78.47 7.87 BMI 30.10 7.29 Women/Men 48/33 NA Appendicular Lean Mass (ALM) 16.53 4.67 Men 19.52 4.96 Women 14.44 3.37 ALM/BMI 0.57 0.14 Men 0.66 0.16 Women 0.51 0.10 • Average BMI is high. • 43% o
Slide 17: SARA-OBS Baseline characteristics
SARA-OBS Baseline characteristics • Physical performance & Plasma biomarkers Variable Mean Standard Deviation 400M (min) 7.10 3.74 Gait speed 400M (m/sec) 0.87 0.27 SPPB 6.46 1.63 Gait Speed in SPPB (sec) 0.74 0.18 Chair stand 1.55 0.77 6MWD 314.07 98.17 hsCRP (mg/L) 5.44 10.20 IL-6 (pg/ml) 6.33 4.1
Slide 18: SARA-OBS Baseline characteristics
SARA-OBS Baseline characteristics • Physical activity measured by Connected Device Mobility pattern of SARA-OBS patients at baseline 8.8% 4.7% Index Activity level Very low mobility % Lying 25.9% 56.4% Low mobility % Sitting Medium mobility % Standing with low activity 4.2% High mobility % Walking l
Slide 19: Next steps: SARA-INT
Next steps : SARA-INT Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week oral administration to patients suffering from age-related SARcopenia, including sarcopenic obesity, Aged ≥65 years and at risk of mobility disability. A double-blind, placebo controlled, randomized INTerven
Slide 20: Conclusions
Conclusions • Preliminary observations in SARA-OBS confirmed recruitment opportunities in sarcopenia trials when using the FNIH criteria. • Similarly to SPRINTT study, low performers at SPPB≤8/12 as an index of mobility disability risk were selected. • Baseline characteristics are comparable to othe
Slide 21: Biophytis Research and Development Team
Biophytis Research and Development Team • SARA Clinical Team • Research Team – Susanna DelSignore – René Lafont – Waly Dioh – Pierre Dilda – Gianluca Zia – Maria Serova – Cendrine Tourette – Mathilde Latil – Carole Margalef – Sissi On – Blaise Didry-Barca • Operations and Non Clinical Team – Philipp
Slide 22: Thank you
biophytis a — Thank you
Slide 23: Main exclusion criteria
Main exclusion criteria • Current treatment with anabolic drugs, i.e. testosterone • Clinical conditions: • Current diagnosis major psychiatric disorders • Alcohol abuse or dependence • Severe arthritis • Cancer requiring active treatment • Lung disease requiring regular use of supplemental oxygen •