ABOUT US
Levicure is a start-up focused on providing patients with type 1 diabetes (T1D) a safe and scalable oral breakthrough therapy that can induce remission through beta-cells regeneration. Our patented combination therapy consists of two FDA approved drugs and proprietary extended-release gastro-retentive formulation of GABA. A clinical proof-of-concept study in T1D patients and animal models demonstrated that the treatment could facilitate remission of T1D by restoring the body’s own insulin production.
CHALLENGE
T1D is an incurable, life-threatening disease, where the insulin producing pancreatic β-cells are destroyed by the patient’s immune system. To survive T1D patients must take daily insulin injections and continuously monitor their blood glucose for the duration of their lives. On average a T1D patient loses 12.2 years of life expectancy due to the disease, with patients suffering from chronic discomfort, severe complications, and diminished quality of life.
SOLUTION
A safe and scalable orally administered treatment significantly improving:
Blood glucose levels
HbA1c
Insulin requirements
Possibility to discontinue insulin in recent-onset T1D patients
SCIENTIFIC EVIDENCE
Proof-of-concept T1DM human study (19 patients):
Early-onset T1D group (10 patients) after 26 weeks of TT
Reduced insulin demands by 69%
Full remission rate - 70 %
Reduced HbA1c by 38%
Increased c-peptide by 147%
Advanced T1D group
(9 patients) after 26 weeks of TT
Reduced insulin demands by 38%
Reduced FBG by 19%
Proof-of-concept 150 NOD mice model study showed that only the triple-therapy has significantly improved key parameters of T1DM and lead to:
Remission of T1D – 55%
Prevention of T1D after 28 days of intake – 100%
MARKET
T1D is a life-threatening chronic disease affecting over 9.8 million people worldwide with a global economic burden of illness of some $110B.
COMPETITIVE ADVANTAGE
Competition - New therapies are in phase 1/2 and potentially could offer only expensive, non-scalable, complicated and invasive procedures such as beta-cell transplantation and infusion, that do not guarantee remission and require a lifetime of immunosuppressive therapy.
Levicure - non-invasive orally administered combination. It is a scalable solution which can lead to remission of T1D through beta-cells regeneration.
IP STATUS
COMBINATION TREATMENT FOR THE REGENERATIVE THERAPY OF T1D PATIENTS:
USA (US11116768B2)
GRANTED
Europe (EP3520786A1)
GRANTED
COMBINATION OF SUBSTANCES FOR REGENERATIVE THERAPY IN PATIENTS WITH T1D
USA (US20210379059A1)
PENDING
COMBINATION OF SUBSTANCES FOR REGENERATIVE THERAPY IN PATIENTS WITH T1D
PCT – filed
COMBINATION OF THERAPEUTIC AGENTS AND METHOD FOR USE THEREOF FOR TREATMENT AND PREVENTION OF AUTOIMMUNE AND NEUROLOGICAL DISORDERS:
PCT – filed
THE TEAM
MANAGEMENT TEAM
Shmuel Levit
Founder & CMO, MD, PhD
- Over 35 years clinical practice
- Head of Endocrinology, Diabetes & Metabolism Institute, Assuta Medical Centers
Mike Teiler
Chief Pharmaceutical officer
- Former VP Generic R&D, Teva
- Former Group VP, Taro
- Former VP Project Management Sun Pharma
- 35 years pharma experience
Yafit Stark
Global Clinical Development Strategy and Execution Advisor, PhD
- Former VP Head of Global Clinical Development, Teva
- Former CCO of Innovative R&D, Teva
- 34 years Teva clinical development experience
Valentine Sukhoveeva
CFO
- Former investment director at private equity fund
- 10+ years of project management roles
Daniil Koshelev
CEO & co-Founder
- Former CEO in biotech start-up
- 12 years executive and business development
Lucy Kosheleva
R&D & co-Founder
- Former VP Investor relationship (12-year experience)
- Uppsala researcher
Olga Karpinchyk
Operations & co-Founder
- Executive at private medical center
- Accounts and operational
ADVISORY PANEL
Amos Anatot
Strategic and Executive Advisor,
Former CEO/COO in Global Food and Pharma
- Former VP, Teva Europe
- Former Frutarom President, IFF
- Former Executive VP, Frutarom
- 19 years pharma experience
- 30 years top executive experience
Alex Rabinovitch
Senior Scientific Advisor, MD, PhD
- Former Prof. of Medicine and Director of the Diabetes Research at the University of Alberta
- Honored with the Excellence in Clinical Research Award from JDRF, 140+ scientific articles
Eric Dutcher
Financial advisor,
MBA
- Over 20 years of experience in leading financial and strategic planning, business development, and operational management
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Chris Howard
Business Advisor, MSc, MBA
- Former CCO and VP with 25 years
of commercial leadership in life science & in vitro diagnostics
- Executed multiple commercial builds
- Led sale of IVD with above-market EBITDA multiple
Alexander Fleming
Scientific/Regulatory Advisor, MD, PhD
- Founder of Kinexum, a multi-faceted, strategic advisory firm, who led landmark FDA approvals
of the first statin, insulin analog, metformin and other novel therapies
- Represented FDA at ICH, WHO, and other initiatives
Daniel Kaufman
Senior Scientific Advisor, PhD
- Professor UCLA School of Medicine
- Honored with numerous awards, 80+ scientific articles
Dr. Walker Hagan
Scientific Advisor
- Published groundbreaking research that revealed that islets for T1D donor lack GABA content resulting in dysregulated insulin secretion
Margery Fischbein
Financial Advisor,
MBA
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