Redox modulating therapy and monitoring
ITALIAN PATENT COMPETITION - February 2018
ANTIOXIDANT (REDOX) CAPACITY
Oxidation: what we know and what is still missing:
• Oxidation is precursor of several pathologies and one of the main aging mechanism
• Glutathione (GSH) is the main anti-oxidant molecule
• Current state of the art: administration of GSH does not reach cells (i.e. low bio-availability), therefore it has a very limited impact on oxidation processes
We are on a mission to make GSH a key solution to a multitude of pathologies
OUR MISSION
We aim at developing new solutions to diagnose and cure GSH-deficit related pathologies
THERAPYNew REDOX modulating compounds
A series of the GSH-omega salts based on S-acyl
substituted GSH, highly bioavailable
Devices for Total Antioxidant Capacity monitoring
DIAGNOSTICSNew REDOX biomarkers
FROM current GSH available on the market
▪ Low bioavailability▪ Low plasma stability
TO S-acyl-GSH derivatives family
GSH-EFA
Linseed essential fatty acids [EFA]
Yeast GSH
▪ High bioavailability▪ High plasma stability
THERAPEUTIC SOLUTION: NEW S-ACIL-GSH DERIVATIVES / HIGH BIOAVAILABILITY
Potential application in pipeline PHARMA AND NUTRACEUTICAL POSITIONING
PH
AR
MA
NASH and liver diseases
Respiratory diseases
Neurodegenerative disorders
Drugs toxicityGSH Gut absorption
Plasma stability
Cellular membrane crossing, separation in GSH and EFA, restoring the original GSH assessment and proper antiOXdefenses
NU
TR
AC
EU
TIC
AL
Age related Redox imbalance
Sport related Redox imbalance
Skin Redox Imbalance
KEY FEATURES
* Nutraceutical Italian market: €2,5 mld/yearEuropean market growth: 7,5% / year
THERAPEUTIC SOLUTION: NEW S-ACIL-GSH DERIVATIVES / POTENTIAL DRUG APPLICATION
IN VITRO
Completed several studies:• crossing cellular membrane • intracellular efficacy
IN VIVO
First in animal study in pipeline [march 2018]:• Plasma stability • Bioavailabilty in mouse
THERAPEUTIC SOLUTION: R&D STRATEGY
Chemi-luminescenza
ORAC TEAC FRAP CUPRACCROCIN
BLEACHING ASSAY
Time > 30’ > 10’ > 10’ > 10’ > 10’ > 10’ < 5’
µLsample
>10 µL >10 µL >10 µL >10 µL >10 µL >10 µL < 5 µL
Whole Blood ** no no no no no no ✔️
Plasma/Siero *✔️ ✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Monoreagente no no no no no no ✔️
Unità di misura Trolox Eq Trolox Eq Trolox Eq Trolox Eq Trolox Eq Trolox EqmMOL/L GSH Eq
Top tiers competitors method for Total Antioxidant Capacity evaluation and TAC-IT
* GSH Plasma <10mL** GSH Whole Blood 550 mL
DIAGNOSTIC SOLUTION: TAC-IT, all the features offered by top tiers competitor for research use plus attractive features for clinical use
✔️
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Patent number Title Filing date Grant
IT1377202 Derivati s-acilici del glutatione, loro sintesi e uso nel trattamento di patologie correlate allostress ossidativo cellulare
12.10.2007 13.07.2010
IT1408451 Composizione farmaceutica per la protezione dei tessuti dall'invecchiamento cellularespecialmente provocato dalle radiazioni ionizzanti
08.11.2011 20.06.2014
EP2775874 Pharmaceutical composition for the prevention and the treatment of degenerative skin disorders especially caused by ionizing radiations
16.05.2013 Patent pending Domandain fase di concessione
US-2016-0228489 Pharmaceutical composition for the prevention and the treatment of degenerative skin disorders especially caused by ionizing radiations
24.05.2015 Petition to revive
IT102017000013599 Composizione farmaceutica per la prevenzione e il trattamento dei deficit mnestici e cognitivi correlati all’invecchiamento
08.02.2017 Patent pending
ITPO20130007Metodo e kit per la determinazione rapida della capacita antiossidante totale su sangueintero e altri campioni biologici
25.10.2013 26.04.2015
EP2866031Kit and method for rapidly determining the total antioxidant capacity in whole blood or other biological sample
29.04.2015 Patent pending
In pipeline new patents related to therapeutic solutions [new S-acil-GSH clinical applications/formulation] and diagnostic solutions [TAC v02]
S-ac
il-G
SHTA
C v
01
SOLOSALE INTELLECTUAL PROPERTY: ROADMAP
2018 2019
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb
Preclinical: animal study bioavailabilty
Clinical:First in human study [PROGERIA]
Preclinical study: animal study toxicity
Preclinical:Manufacture and bench
Clinical:First in human trial
IP:New patents filling
Preclinical study: animal study efficacy
Market access:Regulatory – CE mark
Clinical:First human trial application
IP:New patent filling
Market access:Regulatory – CE mark
Market access:Market launch – initial sales in Europe
S-ac
il-G
SHTA
C v
01
TA
C v
02
STRATEGY: DETAILED TIMELINE 2018
SOLOSALE: TEAM
Ilaria SenesiCFO
Finance & Administration
Gianfranco LiguriPRESIDENT
Research & Innovation
Marco ErediaACCOUNTING ASSISTANT
Viola CalignanoPRODUCT SPECIALIST
Benedetta SarnesiCOMMUNICATION & PR
11
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