Super-antibiotic from Viosera kills superbugs
Viosera targets under-served deadly infectious disease markets. We use existing FDA-approved and off-patent drugs and combine them in ways that enhance their effectiveness against the deadliest infections. We use the safety, chemical, manufacturing, and quality control data and practices already developed for the individual drugs in our combinations to expedite pre-clinical and clinical trials. We then partner with larger pharmaceutical companies for commercialization, marketing and distribution. We take new antibiotic therapies to market fast and at lower cost and risk.
Viosera is currently focusing on MRSA blood stream infection market with plans to expand into the 20x larger Sepsis market post NDA approval. MRSA blood stream infections maim or kill more than 90,000 patients in the US annually and over 170,000 patients in Europe. The cost to the US health care systems is ~$4.2 billion and will worsen since Physicians have only 3 FDA approved treatment options that are often ineffective (< 45% efficacy). The antibiotic options suffer from challenging dosing regimens, drug-drug interactions, acute toxicity problems and antibiotic resistance which increase the likelihood of treatment failure. New antibiotics are prohibitively expensive and have marginal increases in efficacy, while maintaining the same shortcomings of the already approved drugs including antibiotic resistance, which often arises during the first clinical trials.
VT1 is an intravenous antibiotic composed of three safe, off-patent FDA approved antibiotics formulated in a single vial. VT1 cannot be copied or home-brewed by hospitals or physicians and do not suffer the same shortcomings as our competitors. When resistance arises to any one of VT1’s sub-components it makes the remaining components more effective at clearing the MRSA infection. VT1 is 100% effective in mouse MRSA models, is very safe based on animal studies, and is formulated and ready for human trials. We have formed a supply chain that can rapidly scale through clinical trials and with demand as a commercial product. We are evaluating clinical trial sites and have received clear guidance from the FDA which will allow us to rapidly enter phase 1 clinical trials by the beginning of q2 2019. VT1 is protected by a patent filing in the U.S., Europe, and Asia. Polsinelli and Global Patent Group have given positive patentability and freedom to operate reports.