July 11, 2019

The Mission, Preventing Intradialytic Hypotension & Saving Lives. TrioxBio

Intradialytic Hypotension is a life treating debilitating disease occurring in hemodialysis patients with very high rates of morbidity and mortality. The facts are that 10,000 patients are dying from IDH (intradialytic hypotension) complication a year. IDH is a rare disease with no approved treatment as of date. The change in the nephrology and medical community perception and an in depth understanding of the pathophysiology of the diseases, combining with intensive research that was performed on the last 5 years, reveal the severity and the tragical consequences of this life threating disease. To better address IDH a major change must be applied in the dialysis clinics, including the implementation of adequate and effective strategies for the prevention of IDH. Unfortunately, a lack of treatments, awareness and education on IDH had led to poor outcomes. The encouraging fact is the rejuvenation of researchers zooming on IDH, that conducted numerous perspective and retro-perspective trials to reveal the numbers behind this rare disease, that unfortunately was not getting the right attention in the past. The numbers confide mortality risk with hazard ratio of 1.6 or in another words 60% higher mortality in IDH patients compare to average dialysis patients with the same co-morbidities. Intradialytic hypotension believed to be a complex disease with various pathogenesis hypothesis, one of them is excess amount of nitric oxide. Nitric oxide is a signaling molecule that plays a major vital role in the human body physiology. Today it is clear that elevate amount of nitric oxide have a negative effect on numerous diseases including intradialytic hypotension. Over production of nitric oxide cause vasodilatation that results in sever hypotension in dialysis patients i.e.: IDH. MTR-107 (Raviten) a selective novel nitric oxide inhibitor developed by TrioxBio, is currently in phase II of the clinical trials in the US indicated to prevent IDH incidents in hemodialysis patients. Raviten was granted with Orphan Drug Designation by the FDA and lately was granted with Fast Track Designation for the prevention and treatment of IDH. This was a significant step and a very important milestone for the company and the IDH community. The Fast Track Designation was granted after intensive discussion with the agency, that showed a great level of empathy and interest in Raviten solution. I’m happy and thrilled to be part of this journey of improving quality of life and effectively saving lives. The trials attend to start in Q4 of 2018 in the US. TrioxBio is committed to do all in her power and beyond to make sure IDH patients will have accessibility to the treatment in the earliest time possible. I’m happy to share with the IDH community, their families and friends that Raviten will be eligible for a fully reimbursement plan by CMS, that will secure the availability of the drug once approve to pre-defined IDH patients. TrioxBio is a global leader in IDH with an in depth understanding of the disease pathophysiology, close relations with IDH patients and advocacy groups, to ensure the program success. I would like to share with you from a first insight that bringing a novel drug in to the market involved with very bumpy ride, with many hurdles and walls to cross, but it takes only one visit in to a dialysis clinic and a personal discussion with an IDH patients to understand the importance of this mission and to load you with the energy needed to succeed in the mission of saving lives.

Yours,

Shlomo Sadoun

TrioxBio