- The stock price of Matinas BioPharma Holdings Inc (NYSEAMERICAN: MTNB) increased by over 7% pre-market today. This is why it happened.
The stock price of Matinas BioPharma Holdings Inc (NYSEAMERICAN: MTNB) – a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology – increased by over 7% pre-market today. Investors are responding positively to Matinas BioPharma Holdings announcing positive efficacy and safety data from the first 2 cohorts of patients in the ongoing Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) of MAT2203 (oral amphotericin B) for the treatment of cryptococcal meningitis, which is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
The EnACT independent Data and Safety Monitoring Board (DSMB) had recently completed a pre-specified review of available safety and efficacy data from Cohort 2 (stepdown to MAT2203 after 2 days of IV amphotericin) and unanimously recommended progression to the second half of the study. And enrollment in Cohort 3 of EnACT (the safety lead-in for Cohort 4, which will be an all-oral MAT2203 treatment regimen) has commenced and is expected to complete by the end of 2021.
Topline Results from Cohort 2 of EnACT
The key topline results from Cohort 2 of EnACT include eradication of the fungal infection, survival, and safety, including longer-term use of MAT2203 beyond the 2-week induction period.
Potent Early Fungicidal Activity (EFA), Cerebrospinal Fluid (CSF) Sterilization, with No Evidence of Breakthrough Infections During Treatment with MAT2203
— The primary endpoint in EnACT is EFA, a measurement of cerebrospinal fluid fungal clearance. EFA is a well-validated quantitative measure of the efficacy of antifungal agents and is a key surrogate marker for survival. EFAs of less than 0.20 log10 Cryptococcus colony forming units (CFUs) per mL CSF per day are associated with significantly higher mortality and worse clinical outcomes1. EFA measured above this threshold is clinically meaningful and represents robust fungal clearance. In the second cohort of EnACT, the mean EFA achieved with patients treated with MAT2203 was 0.38 log10 CFU/mL/day, with 95% confidence intervals (0.30 to 0.46) significantly higher than the prespecified primary endpoint threshold of >0.20.
— All patients treated with MAT2203 who completed the induction phase achieved sterile CSF cultures during treatment (either during induction or early consolidation phases).
— There was no evidence of breakthrough or relapsed cryptococcal infections observed in any of the patients during treatment with MAT2203 through 10 weeks.
— In Cohort 2, overall survival was 95% in 40 patients randomized to receiving MAT2203.
— In both Cohorts 1 and 2, MAT2203 showed no evidence of renal toxicity or electrolyte abnormalities attributable to MAT2203, no major safety signals, and no use-limiting tolerability issues, even with longer-term treatment with MAT2203 extended beyond induction into the consolidation phase, from week 2 to week 6.
“These results are a major milestone for Matinas, MAT2203, and our LNC platform delivery technology. These data are a clear demonstration of how our LNC platform can have a meaningful clinical impact in a deadly disease, and a validation of how this technology can be used to overcome significant drug delivery challenges, including oral delivery of highly toxic drugs across the blood-brain barrier. The global invasive fungal infection market is projected to be more than $8 billion by 2025, and we believe an oral and well tolerated amphotericin B, which preserves the well-established efficacy of this potent drug, if approved, could be poised to capture a meaningful portion of this growing market, and fill a currently large unmet medical need. Finally, we believe these data are supportive of the enormous potential for our LNC platform delivery technology and a key for potential partners and collaborators who are currently evaluating MAT2203 and broader applications of the LNC platform to antivirals, vaccines, and nucleic acid polymers, such as mRNA.”
— Jerome D. Jabbour, Chief Executive Officer of Matinas
“We believe that the positive data from the first half of the EnACT study represent a groundbreaking achievement in the early step-down treatment of cryptococcal meningitis with the use of an oral formulation of amphotericin and we are preparing to engage with the U.S. Food and Drug Administration (FDA) to review these data as supportive of a potential early approval of MAT2203 as step-down therapy. When viewed against historical measures of survival and eradication of fungal burden and from the standpoint of safety, MAT2203 exceeded expectations. These data also set the stage for potential longer-term treatment options, including prophylaxis, for patients dealing with, or at risk for, deadly invasive fungal infections without the toxicities usually associated with IV amphotericin. We are pleased to move forward to the next part of the EnACT trial and remain grateful to the patients, the principal investigators, and the dedicated study team at the University of Minnesota and in Uganda for their commitment to this important clinical trial.”
— Dr. Theresa Matkovits, Chief Development Officer of Matinas
“Overall, using only two days of intravenous amphotericin B followed by rapid transition to oral LNC amphotericin B therapy was well tolerated, resulted in excellent CSF clearance of the Cryptococcus yeast, and had a 95% survival to date, which exceeds our expectations. We are excited to continue to the next stage of the EnACT trial, testing if oral therapy alone is efficacious.”
— David R. Boulware, M.D., MPH, Professor of Medicine, University of Minnesota Medical School, and co-principal investigator of the EnACT trial
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