Pipeline » MTR107 for Intradialytic Hypotension
A Phase II, Pharmacokinetic and Pharmacodynamic, multicenter clinical trial for the Hemodialysis indication is currently in progress in Israel. The study is a prospective, randomized, double-blind, placebo-controlled, dose range study. The clinical trial evaluates the effects of MTR107 in normalizing blood pressure in 12 ESRD (End-Stage Renal Disease) patients and is being conducted under the FDA’s approved IND number 66,505. Meditor conducted a pharmacokinetic / pharmacodynamic (PK/PD) study as supportive data for obtaining the IND. The objective was to provide information on the hemodynamic effect of MTR107 and to characterize its clearance pattern during dialysis. The patients recruited into the study were known to suffer from frequent bouts of hypotension during the dialysis session, requiring medical intervention. During a routine dialysis session (before MTR107 was administered: baseline data), 4-5 interventions were required to maintain blood pressure within an acceptable range.
Beyond clinical disadvantages associated with the routine treatment modalities, patients often complained about nausea, and vomiting, headaches, dizziness and fatigue.
A dialysis session that was conducted after a single injection of MTR107 (see MTR107 treatment graph above), demonstrated that the patients tolerated the medication very well, and many of the hypotension-associated symptoms disappeared. Moreover, blood pressure was stabilized for almost two hours without overshooting to excessive levels. Given these promising results, Meditor is expecting a similar outcome from the Phase II multicenter clinical trial currently underway in Israel.