July 25 2022 - 06:30AM
Share On Facebook
Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis. The U.S. Food and Drug Administration (FDA) previously granted Orphan, Qualified Infectious Disease Product (QIDP) and Fast Track Designations to MAT2203 for the treatment of cryptococcosis. Matinas is currently preparing to evaluate MAT2203 in a pivotal Phase 3 trial in patients with cryptococcal meningitis.
“The positive opinion for Orphan Drug Designation from the EMA is another important milestone for MAT2203 and reflects our commitment to position MAT2203 for global development and approval,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “We believe that MAT2203 has the potential to transform the treatment of cryptococcosis, as well as other deadly invasive fungal infections. This designation reflects the significant need for new therapies to treat fungal disease and we look forward to working with the EMA and FDA to potentially deliver MAT2203 to patients.”
The orphan medicinal product designation by the European Commission is granted to medicines that treat, prevent, or diagnose a life-threatening or chronically debilitating rare disease, with a prevalence in the EU of not more than five in 10,000 people, and with either no currently approved method of diagnosis, prevention, or treatment or with significant benefit to those affected by the disease. The designation potentially provides certain benefits to Matinas, including 10-year EU market exclusivity upon regulatory approval, if received, reductions in EMA application fees, and access to protocol assistance.
The FDA has previously designated MAT2203 as a QIDP with Fast Track Status and Orphan Drug Disease designation for three additional indications: the treatment of invasive candidiasis, and treatment of invasive aspergillosis, and the prevention of invasive fungal infections due to immunosuppressive therapy.
MAT2203 is Matinas’ orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, which is currently completing Phase 2 clinical development. This oral formulation utilizes the Company’s proprietary LNC technology to deliver amphotericin B in a way that targets infected tissues and avoids the toxicity normally seen with intravenously administered amphotericin B. This novel mechanism of oral delivery has the potential to make MAT2203 an important and invaluable treatment for invasive fungal infections like cryptococcal meningitis, mucormycosis, and invasive aspergillosis.
Spread the love. Be the first to like this post!
Recent MTNB News
- Matinas BioPharma Reports 2022 Financial Results and Provides a Business Update • GlobeNewswire Inc. • 03/15/2023 08:05:00 PM
- Matinas BioPharma to Webcast Conference Call to Discuss 2022 Financial Results and Provide a Business Update on March 15, 2023 • GlobeNewswire Inc. • 03/08/2023 12:00:00 PM
- Matinas BioPharma Announces that MAT2203 Will Be Featured in Two Oral Presentations at ECCMID • GlobeNewswire Inc. • 03/02/2023 12:00:00 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 01/30/2023 09:01:51 PM
- Matinas BioPharma Provides Business Update and 2023 Strategic Outlook • GlobeNewswire Inc. • 01/30/2023 09:01:00 PM
- Matinas BioPharma to Provide Corporate Update and 2023 Business Outlook on January 30, 2023 • GlobeNewswire Inc. • 01/23/2023 12:00:00 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 01/12/2023 12:00:42 PM
- Matinas BioPharma Announces Collaboration with National Resilience to Explore and Evaluate Novel LNC Platform Delivery Technology for Certain Nucleic Acids • GlobeNewswire Inc. • 01/12/2023 12:00:00 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 12/22/2022 04:25:46 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 12/22/2022 04:24:31 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 12/22/2022 04:22:56 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 12/22/2022 04:20:32 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 12/22/2022 04:19:02 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 11/14/2022 10:44:02 PM
- Quarterly Report (10-q) • Edgar (US Regulatory) • 11/02/2022 08:03:18 PM
- Matinas BioPharma Reports Third Quarter 2022 Financial Results and Highlights Recent Progress • GlobeNewswire Inc. • 11/02/2022 08:02:00 PM
- Matinas BioPharma to Webcast Conference Call Discussing Third Quarter 2022 Operational and Financial Results on November 2, 2022 • GlobeNewswire Inc. • 10/27/2022 11:00:00 AM
- Matinas BioPharma Announces Positive Interim Data from the Phase 2 EnACT Trial of MAT2203 for the Treatment of Cryptococcal Meningitis, Exceeding Primary Endpoint Threshold; Patient Survival in All-Oral Cohort 4 Regimen Currently 90% • GlobeNewswire Inc. • 10/21/2022 11:48:01 AM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 10/21/2022 11:02:06 AM
- Matinas BioPharma to Present at the ThinkEquity Annual Global Investment Conference • GlobeNewswire Inc. • 10/21/2022 11:00:00 AM
- Matinas BioPharma Announces Infectious Diseases Society of America (IDSA) has Selected the EnACT Phase 2 Trial Abstract of MAT2203 as its Outstanding Abstract and IDSA Awardee For IDWeek 2022 • GlobeNewswire Inc. • 10/19/2022 11:10:00 AM
- Matinas BioPharma to Present New MAT2203 (Oral Amphotericin B) Data During IDWeek 2022 • GlobeNewswire Inc. • 10/12/2022 11:00:00 AM
- Proxy Statement (definitive) (def 14a) • Edgar (US Regulatory) • 09/22/2022 09:02:26 PM
- Matinas BioPharma Announces Chairman Succession Plan • GlobeNewswire Inc. • 09/21/2022 11:00:00 AM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 09/13/2022 11:01:55 AM
Hollywall Entertainment Inc., (OTC:HWAL) Announces the completion of its 2021 and 2020 Audit (s) • HWAL • Mar 24, 2023 12:48 PM
Glucose Health, Inc. Fiscal 2022 Annual Report • GLUC • Mar 23, 2023 3:23 PM
Nextech3D.ai Announces Its AI-Powered SaaS Platform Toggle3D Experiences A +963% Jump in Users in 60-Days Crossing Over 1000 Users • NTAR • Mar 23, 2023 7:07 AM
Lifecycle Assessment by Benchmark Shows TMC's NORI-D Nodule Project Could Outperform Land-Based Routes of Producing Nickel, Copper and Cobalt in Almost Every Impact Category Analyzed • TMC • Mar 22, 2023 1:44 PM
Fineqia Announces Partnership with Paris Blockchain Week to Accelerate Digital Asset Innovation • FNQQF • Mar 22, 2023 10:03 AM
E-Cite and ClearMarket Launch Nationwide EV Distribution Network Becoming the First All EV Dealership Opening in the Cerritos Auto Square, the World's Largest Automall • VAPR • Mar 22, 2023 9:41 AM