Colysis is a Clinical Stage NY State corporation founded in 2021 to develop treatments for covid associated inflammatory coagulopathy. The offices and laboratories of Colysis, Inc are at 73 High Street, Buffalo NY.
Colysis is raising funds from Investors, strategic partners, Granting Agencies and Health Systems in order to develop a line of sequentially administered treatments for acute hospitalized patients with COVID-19 and carrying forward to treatments for Long COVID. A slideset explaining the technology is presented.
CoLysis Project Team
Jerome J. Schentag PharmD is CoLysis Founder and CEO/CSO. Dr Schentag was a Professor at University of Buffalo for 40 years, with over 350 publications and over patents. The majority of Dr Schentag’s publications describe antibiotic pharmacokinetics and pharmacodynamics, and the clinical interface is with ICU and critical care, specializing in pneumonia, sepsis and septic shock. Recent work has applied these concepts to COVID-19. Dr Schentag is also CEO of CPL Associates LLC, a clinical contract research organization also based at 73 High Street and supporting the clinical studies of CoLysis in COVID-19. Stephen Yelity is CoLysis Founder and CFO. Mr. Yelity was a financial officer of J&J prior to becoming and entrepreneur and a founder of BusStim LLC, a virtual biotech accelerator based in NYC. CoLysis was designed by BusStim. The CoLysis clinical team includes Dr Umesh Sharma, Cardiologist and CSO for the study of AC-SDKP peptide as a regulator of cardiac damage in COVID-19; Maya Chilbert, cardiology and anticoagulation clinical pharmacist at UB and inventor of the inflammatory Coagulation index, Dr Nima Subramanian Data Analyst at CPL Associates and co-inventor of the inflammatory coagulation index, Dr David Jacobs, Epidemiology and Statistician at UB, Dr Filip Stefanovic, Neural Net modeler in Biomedical Engineering at UB. CoLysis has Partnered with Dr Thomas Argentieri and Dr Lyndon Young of Young Therapeutics to develop their NIH funded peptide YT-002 in cardiac re-perfusion injury. CoLysis has partnered with Pr Umesh Sharma of UB Cardiology in order to develop Ac-SDKP as a treatment for Cardiomyopathy following viral injury using a mitochondrial targeted peptide that appears to delay or prevent fibrosis. CoLysis has partnered with Dr Jan Johansson of Artery Therapeutics to develop CS6253 peptide (ABCA1) as a means of removing NETs and other inflammatory products of COVID-19 from organs and tissues. These partnerships aim to deal with the downstream tissue related injury profile caused by imbedded inflammatory clots in organs and tissues and hypothesized by our team to explain Long-COVID.
Project Description and Preclinical/Clinical Validation
COVID19 causes severe inflammation leading to systemic coagulopathy and fatal respiratory failure. While traditional anticoagulants benefit by slowing down clot formation, they do not dissolve clots already formed and obstructing the pulmonary blood flow. CoLysis, Inc. proposes systematic use of Tissue plasminogen activator (tPA) clot lysis in pulmonary arterial blood flow obstruction. Our plan is to use Tenecteplase TNK for clot lysis based on an in-vitro model of NET associated clots and clot Lysis. Under an Investigational IND, our clinical trial protocol will apply tPA to COVID19 ICU patients selected and monitored using thromboelastography (TEG), which adds considerable specificity and improves the safety profile using clot lytic therapy. Each patient enrolled in our IRB approved protocol will be studied daily to assess current coagulation balance with this index and we will then use these data to decide the optimal time to apply tPA and calculate the personalized dose. Following clot lysis, the index will be further used to define the duration of effect and determine the potential need for additional heparin and/or tPA. Further model validation will be conducted focusing on the index’s predictive power related to patient response variability. Laboratory study of both clinical biomarkers and laboratory tests will inform decisions relevant to timely supportive care. The objective will be to maintain daily coagulation system balance to improve oxygenation. The index will detect organ reperfusion injury biomarkers and inform the need for novel anti-reperfusion injury therapeutics in development by our partnering companies, Young Therapeutics and Artery Therapeutics. The complete time and events record of each patient on this protocol will be used to define the efficacy and safety of tPA and heparin. Predictive tools will be made available in methods publications as a software application/calculator and illustrated in the paper describing the clinical trial results.
Topline Project Needs and Budget
The topline project budget includes the proposal to ESD for funding of $1,651,750 for CoLysis and its health system partners. The IRB approved clinical protocol will treat selected severe COVID-19 patients with the objectives to refine and validate its Coagulopathy Index, then deploy and learn how to use it prospectively in a study of at least 25 COVID-19 patients given clot Lysis therapy with tPA or TNK. The CoLysis team has worked together for many years, with complicated critical care patient populations, having done ICU pneumonia, Sepsis, and recently Immune Checkpoint Associated myocarditis studies. Use of tPA and treatments for re-perfusion injury that follows is well within our combined skillset.
We have attached our Investor Slide deck which reviews COVID-19 pathophysiology and describes our approach, considering both acute and Long COVID