Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) announced Wednesday that it will commence a Part 2 study of MAT2203 for the treatment of HIV patients with cryptococcal meningitis.
The company’s move comes after the independent Data Safety Monitoring Board (DSMB) for the EnACT study completed its planned review of initial safety and tolerability data from the Part 1 dose-escalation phase of MAT2203. DSMB has unanimously approved proceeding with enrollment in the Part 2 efficacy phase at 2 grams of drug daily, the highest dose tested in Part 1.
Matinas, based in Bedminster, New Jersey, said the 2g dose will be tested in the 2-week induction phase of treatment. Data from Part 1 demonstrated that MAT2203 was safe and well-tolerated across all three daily doses tested (1g, 1.5g and 2g).
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Part 2 of the EnACT study will explore the use of MAT2203 for both induction and maintenance therapy in HIV-patients with cryptococcal meningitis, a life-threatening fungal infection most commonly observed in immunocompromised individuals.
“We are extremely pleased with our progress in the EnACT trial, which remains on track. Early observations of MAT2203, including the initial safety and tolerability data from Part 1, along with the DSMB’s endorsement to proceed with the highest dose tested, continue to show MAT2203’s potential to provide meaningful benefit to this vulnerable patient population,” said Theresa Matkovits, Matinas’ chief development officer, in a statement.
“We look forward to dosing the first patient in Part 2 of the study in the upcoming weeks and expect to provide updates on the anticipated progression from patient cohort to cohort throughout 2020.”
Dr David Boulware, professor of medicine at the University of Minnesota and principal investigator for the trial, said the dose-escalation portion of the EnACT study has provided important safety and tolerability information about using multiple doses per day to increase the total daily dose.
"The upcoming efficacy portion of the randomized clinical trial in persons with cryptococcal meningitis will allow for further evaluation of the safety and efficacy of MAT2203,” he said.
“I am very encouraged by what we have seen to date and excited to advance the EnACT study into the efficacy phase. If successful, an oral amphotericin formulation has the potential to provide invaluable oral and well-tolerated treatment for severe invasive fungal infections in these difficult to treat patients.”
EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) is an open-label, sequential cohort study, financially sponsored by the National Institutes of Health (NIH).
The trial utilizes MAT2203, which applies Matinas’ LNC drug delivery technology to orally deliver amphotericin B, an otherwise IV-only, highly toxic, fungicidal drug for the treatment of HIV-patients with cryptococcal meningitis.
Oral MAT2203 is designed to target delivery directly to infected tissues, protecting the body from unnecessary exposure to amphotericin B, and is expected to be a safer alternative to the traditional IV-forms of this highly potent drug with a lower propensity for kidney toxicity.
The study consists of two distinct parts; Part 1 is designed to determine the maximum tolerated dose among people living with HIV but who do not have a fungal infection. Part 2 is a prospective randomized trial evaluating the safety, tolerability and efficacy of MAT2203 in HIV-infected patients with cryptococcal meningitis, compared to treatment with standard IV-administered amphotericin B as induction therapy.
As previously reported, the Food and Drug Administration has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications: The prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.
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