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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 full remission. Our patented combination therapy consists of two FDA approved drugs and proprietary modified-release 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, in some cases leading to complete insulin withdrawal in humans. This scalable treatment can provide T1D patients with a safe, non-invasive, orally administered medication that facilitates remission, reduces complications, and vastly improves quality of life.

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:

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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

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Reduced insulin demands by 69%
Full remission rate - 70 %
Reduced HbA1c by 38%
Increased c-peptide by 145%

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Advanced T1D group

(9 patients) after 26 weeks of TT

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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:

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Remission of T1D – 55%

Prevention of T1D after 28 days of intake – 100%

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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

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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.

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Levicure - non-invasive orally administered combination of well-known and FDA approved drugs. It is a scalable solution which can lead to remission of T1D and significantly improve the quality of life for patients with T1D patients.

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

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Shmuel Levit

Founder & CMO, MD, PhD

- Over 35 years clinical practice

- Head of Endocrinology, Diabetes & Metabolism Institute, Assuta Medical Centers

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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

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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

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Valentine Sukhoveeva

CFO

- Former investment director at private equity fund
- 10+ years of project management roles

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Daniil Koshelev

CEO & co-Founder

- Former CEO in biotech start-up

- 12 years executive and business development

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Lucy Kosheleva

R&D & co-Founder

- Former VP Investor relationship       (12-year experience)

- Uppsala researcher

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Olga Karpinchyk

Operations & co-Founder

- Executive at private medical center
- Accounts and operational

ADVISORY PANEL

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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

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Alex Rabinovitch
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

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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

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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

PART OF THE
STARTUP HEALTH
T1D MOONSHOT FELLOWSHIP

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