Matinas BioPharma Holdings Inc. (NYSEAMERICAN:MTNB) has announced the completion of a pre-specified review of the first cohort of the EnACT study by the independent Data and Safety Monitoring Board (DSMB).
Matinas to progress to the second cohort in EnACT study
The DSMB recommended that the company progresses to a second patient cohort of Encochleated Oral Amphotericin for Cryptococcal Meningitis trial. The company expects to commence enrolment in the second randomized EnACT cohort with 40 patients in active treatment. The DSMB will evaluate the efficacy and safety of the data in mid next year.
Theresa Matkovits, the company’s chief development officer, said that cohort progression in the study is a huge milestone for developing MAT2203. She added that the unanimous DSMB recommendation is encouraging, and it supports the company’s views regarding the overall efficacy and safety of MAT2203. Theresa indicated that the company is promptly looking forward to starting enrolment in the second EnACT cohort, which will offer strong efficacy regarding the safety and efficacy of MAT2203.
Matkovits said that Cryptococcal meningitis is a fatal fungal disease that results in invasive, severe brain infections. She added that they believe oral amphotericin B formulation will significantly reduce toxicity risk without compromising efficacy. Based on the profile, MAT2203 can potentially be an invaluable solution for patients and physicians and thus advance the standard of care for treating invasive, severe fungal infections.
Approval vital in validating Matina’s LNC delivery platform
Matina’s BioPharma’s chief scientific officer Raphael Mannino said that EnACT cohort progression is a huge milestone for the company in validating the potential of its LNC platform delivery tech. He added that the DSMB approval to progress to the second cohort is an encouraging sign that MAT2203 is bioavailable orally and can successfully cross the blood brain barrier. Mannino said that ongoing success in EnACT demonstrates that oral LNC therapy to the brain is possible. Matinas is optimistic that its LNC platform could be an important option to traditional often problematic delivery modes like viral vectors or lipid nanoparticles.