The following table summarizes key information about the company's four product candidates:
Raviten (MTR-105) is a slow drip injectable form of MTR-104, being developed for the treatment of vasoplegic syndrome (hypotension associated with cardiopulmonary bypass) in patients undergoing cardiac surgery. Specifically, Raviten is a 10% solution of MTR-104, intended to be administered intravenously, supplied in 250ml slow drip bags. Raviten's safety was tested in a Phase I clinical study conducted in Germany between 2000-2001, and the company was granted Investigational New Drug (IND) approval (#66,505) by the FDA in 2003, as a result of this and other clinical studies conducted in Eastern Europe. TrioxBio plans to start a Phase II clinical trial in the U.S. for the vasoplegic syndrome indication, under the aforementioned IND, in 2020.
Ravimig (MTR-106) is an oral tablet form of MRT-104, being developed for the acute treatment of migraine. Ravimig has been approved for commercialization in Moldova (Eastern Europe) in blisters containing two tablets of 50 mg each. Leveraging on the studies conducted to obtain marketing approval in Moldova, and on those carried out to support Raviten's IND application, TrioxBio will seek FDA approval to start a Phase II clinical trial for the migraine indication in Europe and the U.S. The company plans to complete the study in 2021. Given that the application will be evaluated by a different division of the FDA, Ravimig will be covered by an IND different from that for Raviten.
Raviten (MTR-107) is an injectable 1.2ml ampule of MTR-104, being developed for the prevention of intradialytic hypotension. The company assigned Raviten two different code names to help distinguish its clinical development programs, but both MTR-105 and MTR-107 were included in the IND approved by the FDA, each with its own approved study protocol. MTR-107 was granted Orphan Drug Designation in 2016 and Fast Track designation in 25th of May 2018. An Engineering batch of 50,000 ampules of MTR-107 was manufactured by Patheon Monza Italy during Q1 2018. TrioxBio plans to start a Phase II clinical trial in USA with DaVita for the intradialytic hypotension indication, under the aforementioned IND, during the last quarter of 2018.
Raviclust (MTR-108) is an intranasal spray formulation of MTR-104, being developed for the acute treatment of cluster headaches. It was conceived by TrioxBio, in response to the FDA's requirement to demonstrate efficacy within 30 minutes, as opposed to the 2 hours required in the clinical trials for migraine. Nevertheless, TrioxBio intends to include Raviclust in the same IND application as Ravimig, and to start a Phase II clinical trial for the cluster headache indication in Europe and the U.S. in 2019.