Redox modulating therapy and monitoring - .Sport related Redox imbalance Skin Redox ... Composizione

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Text of Redox modulating therapy and monitoring - .Sport related Redox imbalance Skin Redox ... Composizione

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

Lsample

>10 L >10 L >10 L >10 L >10 L >10 L < 5 L

Whole Blood ** no no no no no no

Plasma/Siero *

Monoreagente no no no no no no

Unit 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

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 allinvecchiamento

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

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01

SOLOSALE INTELLECTUAL PROPERTY: ROADMAP

http://worldwide.espacenet.com/publicationDetails/biblio?CC=IT&NR=PO20130007&KC=&locale=en_EP&FT=Ehttp://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2866031&KC=&locale=en_EP&FT=E

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

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TA

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STRATEGY: DETAILED TIMELINE 2018

SOLOSALE: TEAM

Ilaria SenesiCFO

Finance & Administration

Gianfranco LiguriPRESIDENT

Research & Innovation

Marco ErediaACCOUNTING ASSISTANT

Viola CalignanoPRODUCT SPECIALIST

Benedetta SarnesiCOMMUNICATION & PR

11

Science for life