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.
