R&D: Clinical Development Strategy
MTR-105: Cardiac Surgery related Hypotension (Vasoplegic Syndrome)
A Phase II trial of 32 patients for the cardiac surgery-induced hypotension indication is planned to take place in the U.S. The study will assess the safety, pharmacokinetics and pharmacodynamics of MTR-105 in cardiac surgery patients who have developed hypotension during weaning off after cardiopulmonary bypass. The study will be conducted under the FDA’s approved IND #66,505.
TrioxBio plans to start a Phase II study for the migraine indication in Europe and the U.S. this year. The study will be a multicenter, randomized, double-blinded, placebo-controlled, parallel-group, and dose-ranging, 350-patient study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of the MTR-106 oral tablets in the acute treatment of migraine attacks.
MTR-107: Intradialytic Hypotension
A Phase II clinical trial for the hemodialysis indication is planned to commence shortly in Europe. The study will be a prospective, two-center, randomized, double-blind, placebo-controlled, four-treatment, four-period, cross-over study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of three doses of MTR-107 for the prevention of intradialytic hypotension (IDH) in end stage renal disease (ESRD) patients.
MTR-108: Cluster Headache
Given the role of nitric oxide in cluster headaches, TrioxBio has decided to test the ability of MTR-104 to alleviate cluster headache attacks. As these attacks generally reach their full force within five or ten minutes after onset, drugs to treat them need to be promptly bioavailable. In fact, while the customary primary endpoint in clinical trials involving acute treatment of migraine is pain response (relief or freedom) at 2 hours, the customary primary endpoint in clinical trials involving acute treatment of cluster headache is pain response at 30 minutes. For that reason, TrioxBio has embarked on the development of a new nasal spray formulation (MTR-108).
Once TrioxBio completes the formulation of the nasal spray, it will launch a phase II study in Europe and the U.S. The study will be a randomized, double-blinded, parallel, placebo-controlled, dose-escalating, 50-patient study to evaluate the safety, efficacy and pharmacokinetics of MTR-108 in the treatment of cluster headache attacks. Given the similarities between cluster headache and migraine with regard to the role of nitric oxide, and the success of MTR-106 in TrioxBio’s previous clinical studies, TrioxBio is very optimistic about the potential of MTR-108.