Redox modulating therapy and monitoring - ITALIAN PATENT COMPETITION - February 2018 - Deloitte
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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
THERAPY DIAGNOSTICS
New REDOX modulating compounds New REDOX biomarkers
A series of the GSH-omega
salts based on S-acyl Devices for Total Antioxidant
substituted GSH, highly Capacity monitoring
bioavailable
THERAPEUTIC SOLUTION: NEW S-ACIL-GSH DERIVATIVES / HIGH BIOAVAILABILITY
FROM TO
current GSH available on the market S-acyl-GSH derivatives family
Linseed essential fatty
Yeast GSH
acids [EFA]
GSH-EFA
▪ Low bioavailability ▪ High bioavailability
▪ Low plasma stability ▪ High plasma stability
THERAPEUTIC SOLUTION: NEW S-ACIL-GSH DERIVATIVES / POTENTIAL DRUG APPLICATION
Potential application in pipeline
KEY FEATURES
PHARMA AND NUTRACEUTICAL POSITIONING
NASH and liver
diseases
PHARMA
Respiratory diseases
Neurodegenerative
disorders
GSH Drugs toxicity
Gut absorption
Plasma stability
NUTRACEUTICAL
Age related Redox
imbalance
Cellular membrane crossing,
separation in GSH and EFA, Sport related Redox
restoring the original GSH imbalance
* Nutraceutical Italian
assessment and proper antiOX market: €2,5 mld/year Skin Redox
defenses European market growth: Imbalance
7,5% / year
THERAPEUTIC SOLUTION: R&D STRATEGY
IN VITRO
Completed several studies:
• crossing cellular membrane
• intracellular efficacy
IN VIVO
First in animal study in pipeline [march 2018]:
• Plasma stability
• Bioavailabilty in mouseDIAGNOSTIC SOLUTION: TAC-IT, all the features offered by top tiers competitor for research use
plus attractive features for clinical use
Top tiers competitors method for Total Antioxidant Capacity evaluation and TAC-IT
CROCIN
Chemi-
ORAC TEAC FRAP CUPRAC BLEACHING
luminescenza
ASSAY
Time > 30’ > 10’ > 10’ > 10’ > 10’ > 10’ < 5’
µL
>10 µL >10 µL >10 µL >10 µL >10 µL >10 µL < 5 µL
sample
Whole Blood ** no no no no no no ✔️
✔️
Plasma/Siero *
✔️ ✔️ ✔️ ✔️ ✔️ ✔️ ✔️
✔️
Monoreagente no no no no no no ✔️
✔️
mMOL/L
Unità di misura Trolox Eq Trolox Eq Trolox Eq Trolox Eq Trolox Eq Trolox Eq
GSH Eq
* GSH PlasmaSOLOSALE INTELLECTUAL PROPERTY: ROADMAP
Patent number Title Filing date Grant
Derivati s-acilici del glutatione, loro sintesi e uso nel trattamento di patologie correlate allo 12.10.2007 13.07.2010
IT1377202
stress ossidativo cellulare
Composizione farmaceutica per la protezione dei tessuti dall'invecchiamento cellulare 08.11.2011 20.06.2014
IT1408451
specialmente provocato dalle radiazioni ionizzanti
S-acil-GSH
Pharmaceutical composition for the prevention and the treatment of degenerative skin 16.05.2013 Patent pending Domanda
EP2775874
disorders especially caused by ionizing radiations in fase di concessione
Pharmaceutical composition for the prevention and the treatment of degenerative skin
US-2016-0228489 24.05.2015 Petition to revive
disorders especially caused by ionizing radiations
Composizione farmaceutica per la prevenzione e il trattamento dei deficit mnestici e
IT102017000013599 08.02.2017 Patent pending
cognitivi correlati all’invecchiamento
Metodo e kit per la determinazione rapida della capacita antiossidante totale su sangue
ITPO20130007 25.10.2013 26.04.2015
TAC v01
intero e altri campioni biologici
Kit and method for rapidly determining the total antioxidant capacity in whole blood or
EP2866031 29.04.2015 Patent pending
other biological sample
In pipeline new patents related to therapeutic solutions [new S-acil-GSH clinical applications/formulation]
and diagnostic solutions [TAC v02]STRATEGY: DETAILED TIMELINE 2018
2018 2019
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb
Preclinical: Preclinical study: Preclinical study:
animal study bioavailabilty animal study toxicity animal study efficacy
S-acil-GSH
IP:
New patents filling
Market access:
Regulatory – CE mark
Clinical:
First human trial application
Clinical:
TAC v01
First in human study [PROGERIA]
Market access:
Market launch – initial sales in Europe
Preclinical:
Manufacture and bench
TAC v02
IP:
New patent filling
Clinical:
First in human trial Market access:
Regulatory – CE markSOLOSALE: TEAM
Ilaria Senesi Gianfranco Liguri
CFO PRESIDENT
Finance & Administration Research & Innovation
Marco Eredia Viola Calignano Benedetta Sarnesi
ACCOUNTING ASSISTANT PRODUCT SPECIALIST COMMUNICATION & PRScience for life
11You can also read
