SCAVENGING ON SEPSIS. DEVELOPMENT OF SEPSIS SPECIFIC DRUGS FROM HUMAN SCAVENGER RECEPTORS

Project Information

SEPSCAV

Grant agreement ID: 854707

DOI

10.3030/854707

Project closed

EC signature date 28 January 2019

Start date 1 February 2019

End date 31 July 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SEPSIA THERAPEUTICS SL
Spain

Periodic Reporting for period 1 - SEPSCAV (SCAVENGING ON SEPSIS. DEVELOPMENT OF SEPSIS SPECIFIC DRUGS FROM HUMAN SCAVENGER RECEPTORS)

Reporting period: 2019-02-01 to 2019-07-31

Summary of the context and overall objectives of the project

The current bacterial Sepsis scenario affects over 30 million (M) people infected globally leading to 8M deaths/year caused by a dysregulated host response to infections acquired both in the community setting or in health care facilities. Health care-associated infections affect hundreds of millions of patients worldwide every year with Multi-drug resistant (MDR) bacteria increasing sepsis risk. To this day there is no sepsis-specific medicine and sepsis treatment continuous to be based on a combination of antibiotic/fuid-resuscitation/vasopressor drugs of only limited success. Sepsia Therapeutics SL is developing SIXTIDE, a synthetic undecapeptide derived from human CD6, as an unprecedented non-antibiotic strategy active both against bacterial virulence factors and host inflammatory and immune mediators. SIXTIDE protects mice from death in experimental sepsis, in a time- and dose-dependent manner. Sepsia Therapeutics holds all relevant intellectual property rights aiming for market entry in Q1-2023 through injectable SIXTIDE.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work undertaken as part of the SME phase 1 project SEPSCAV confirms the validity of the objectives set out in the SEPSCAV proposal, namely: (1) Production of SIXTIDE peptide and development/validation in vivo (mouse model) of a human approved drug formulation for SIXTIDE, to address infection and inflammation simultaneously as a game-changing approach to Sepsis therapy, through pre-clinical and clinical trials, and into the market. (2) Assessment of economic viability of SIXTIDE including competition analyses, (3) establishment of patent national phases and Freedom-to-operate report of Sepsia’s IP portfolio. (4) Approximation to an early Business plan through a business canvas model.

The concept and approach remain valid and the potential impact has been re-evaluated in the current and foreseeable sepsis scenario. A detailed analysis of the potential of the SIXTIDE candidate has been performed in the light of (1) the results obtained with a new vehicle approved for human application (2) the projected patient population to which the product may be targeted, (3) the competitive scene which SIXTIDE will face in coming years, and, (4) an approximation to a working business model, identifying undefined variables is provided and financial support from industrial partners BCN Peptides and GP Pharm has been secured.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

SIXTIDE synthesis and solubility has been studied for up to 11 different vehicle formulations to show efficacy in an in vivo mouse model [FIGURE 1: SIXTIDE in vivo mouse survival graph]. A single dose toxicity has been carried out in healthy mice to show lack of SIXTIDE-associated toxicity. A Freedom-to-Operate and National phase entries have been requested for Sepsia’s IP portfolio. A feasibility study, competition analysis and business plan have been carried out to show project viability.

For the purpose of approximating a turnover estimate for the first three years of commercial operation by Sepsia, a conservative scenario is assumed in which known financial variables are arbitrarily fixed to:
A- A single 1-30 mg dose is administered per patient and sufficient to reverse severe sepsis phase
B- A single 1-30 mg dose of SIXTIDE can be sold for 1500€, as the only sepsis-specific drug in the market acting on infection and inflammation simultaneously. A conservative approach would imply the reach of between 1 to 10% of the European market in the first 3 years, with 3,4M patients, resulting in annual sales of 34,000 (1%) and 340,000 (10%) units and generating turnovers of 51M€ and 510M€, within current peptide manufacturing capacity from industrial partner BCN Peptides. [FIGURE 2: SEPSIA THERAPEUTICS EXPECTED MARKET SHARE/TURNOVER/HEADCOUNT TABLE OVER FIRST 3 YEARS OF COMMERCIAL OPERATION]

A total of 16 companies, including SEPSIA Therapeutics, are currently involved in Sepsis drug/therapy development. These companies mostly develop candidate drugs (from pre-clinical to clinical phase III) that are suited for sepsis therapy, but are not sepsis-specific, classed as either: drugs that do not fight bacterial infection directly, or drugs that function as hypertensive, anti-thrombotic, anti-coagulation, immune-stimulation and/or anti-inflammation agents to prevent organ damage. Our competition analysis shows that the only company simultaneously targeting bacterial growth and inflammation is Sepsia’s drug candidate SIXTIDE. [FIGURE 3: SEPSIA THERAPEUTICS COMPETITION ANALYSIS PLOT]

Business and customer needs and undetermined variables have been identified and listed in the feasibility study, and financial projections have been made to show project concept validity and business viability. Sepsia Therapeutics has secured funds from industrial partners to proceed to further pre-clinical tests.

Sepsia Competition Plot

In vivo results

Sepsia Market Share