LTX 109 BIO International Philadelphia 2015
Lytix Biopharma company background Established in 2003 to develop and commercialize medical applications of lytic peptides originating from the University of Tromsø Founders: Professors Øystein Rekdal (CSO), John Sigurd Svendsen (Discovery Director and Board member) Technology platform based on de novo designed host defence peptides with potential to meet two substantial medical challenges: Treatment of infections regardless of resistance, lead product candidate selected and patent filed in 2007 LTX 109 Cancer therapy that increase patient specific immune response to attack cancer, lead product candidate selected and patent filed in 2009 LTX 315
LTX 109 is a novel topical antimicrobial Stable membrane active host defense peptide mimetic Topical anti infective Efficient killing of microorganisms Broad spectrum of activity Clinical stage product Safe and well tolerated PoC in Phase II impetigo Significant eradication of nasal MRSA/MSSA in Phase I/II Phase I/II mild DFI ongoing Novel mode of action Effect on resistant bacteria Low propensity for resistancy
Intellectual property rights LTX-109 - Strong patent protection up to 2032 Covers various methods of use, composition of matter, major markets (US, EU, etc.) and additional functions
A significant opportunity in Diabetic Foot Infections (DFI) Large number of patients ~2.3 million cases of DFIs in the G7 annually KOLs prefer topical treatment option Lower potential for resistance vs. systemic antibiotics Topical formulation with improved safety Potential convenience/compliance advantages once daily dosing Broad spectrum coverage Payers indicate premium pricing Serious morbidity associated with DFIs Acute nature of the condition Topical advantages vs. existing systemic agents Multiple hundreds of millions USD opportunity (DRG Research, June 2014)
An attractive opportunity in Diabetic Foot Infections (DFI) LTX 109 has a significant opportunity in DFI, where base case indicate a several hundred million US$ market in the G7 only (Decision Resources Group, June 2014) There are ~2.3 million cases of DFIs in the G7 annually, of which ~50% are mild KOLs preferred option could be used in over 50% of confirmed mild cases Lower potential for resistance vs. systemic antibiotics Topical formulation with improved safety Potential convenience/compliance advantages once daily dosing Broad spectrum coverage Payers indicate a price point in DFIs of around ~$400 500 per course in the US, driven primarily by: Serious morbidity associated with DFIs Acute nature of the condition Topical advantages vs. existing systemic agents
LTX 109 pathway to market for DFI 2014 2015 2016 2017 2018 2019 2020 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 Phase I/II PoC DFI Go/No go for PhII Phase I Sensitization and Irritation studies Phase III Pivotal study x2 Includes enrolment and treatment *Pending regulatory validation Data collection, submission/preparation for regulatory filing Outlicenced to partner First Regulatory submission Target first approval
Attractive licensing opportunity Novel mode of action (stable peptide mimetic) Topical antimicrobial Low propensity for resistance Broad spectrum activity Safety advantages vs systemics PoC in Impetigo Strong long lived IP Defined patient population in DFI High clinical unmet need Significant commercial opportunity We are actively seeking a partner for full licensing or co-development
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