- The stock price of Matinas BioPharma Holdings Inc (NYSEAMERICAN: MTNB) increased over 10% during intraday trading today. These are the details.
The stock price of Matinas BioPharma Holdings Inc (NYSEAMERICAN: MTNB) increased over 10% during intraday trading today. This is a continuation of momentum as the stock price is now up more than 44% over the past week.
Investors are responding positively to Matinas BioPharma Holdings recently 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 is 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 an 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.