Matinas BioPharma Provides Update to MAT2203 Regulatory and Development Pathway Following Feedback from FDA
- None.
- None.
The recent developments regarding Matinas BioPharma's MAT2203, an investigational drug using lipid nanocrystal (LNC) technology for treating invasive aspergillosis, signify a crucial step towards potential FDA approval. Invasive aspergillosis is a serious infection caused by the Aspergillus fungus, often affecting individuals with weakened immune systems. Currently, treatment options are limited, denoting a substantial unmet medical need.
From a medical research perspective, the alignment with FDA on trial design enhances the likelihood of a successful Phase 3 outcome. This is pivotal as it not only determines the drug's efficacy and safety profile but also its marketability. The Expanded Access/Compassionate Use Access program's positive data could infer a favorable risk-benefit ratio, which is a key determinant in FDA approval decisions.
Should MAT2203 demonstrate efficacy and safety in the Phase 3 trial, it has the potential to become a significant treatment option in the antifungal market, which is projected to grow in the coming years due to rising incidence of fungal infections and resistance to existing antifungal drugs.
The feedback from the FDA and the upcoming meeting to finalize the Phase 3 study design are material events for Matinas BioPharma's stock valuation. The progression of MAT2203 through clinical trials could have a substantial impact on the company's financial future, considering the high costs associated with drug development and the potential revenue from a successful product launch.
Investors should note that clinical trial outcomes are inherently uncertain and can significantly affect biopharmaceutical companies' stock prices. Positive trial results often lead to stock appreciation, while negative results can lead to declines. Furthermore, the active partnership discussions mentioned could result in collaboration or licensing agreements, providing capital and shared risk, which are critical for smaller biopharmaceutical firms with limited resources.
It is also important to consider that the biopharmaceutical sector is subject to regulatory and market risks. However, a successful Phase 3 trial and subsequent FDA approval could position Matinas BioPharma favorably within the niche market of antifungal treatments, potentially leading to an increase in market share and investor confidence.
The antifungal drug market is an area of high interest due to the limited number of effective treatments and the growing problem of drug-resistant fungi. MAT2203's use of lipid nanocrystal (LNC) technology represents an innovative approach to drug delivery, potentially offering advantages over existing therapies in terms of efficacy, safety and patient compliance.
An understanding of the competitive landscape is crucial. If MAT2203 is approved, it would enter a market currently dominated by a few key players. Its success will depend on its clinical benefits compared to existing treatments and its ability to penetrate the market quickly.
Furthermore, the strategic importance of partnership discussions cannot be overstated. Such partnerships could provide Matinas with additional resources and expertise, which are often critical for the commercial success of new therapies, especially for smaller biopharmaceutical companies.
Written Preliminary Comments on the Phase 3 Registration Trial for MAT2203 Move Company Closer to Full Alignment with FDA
Matinas to Meet with FDA Early in the First Quarter of 2024 to Finalize Phase 3 Study Design
Partnership Discussions Remain Ongoing for MAT2203
BEDMINSTER, N.J., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform technology, announces receipt of written feedback from U.S. Food and Drug Administration (FDA) on its proposed revised protocol for a Phase 3 study of MAT2203 in patients with invasive aspergillosis with limited or no treatment options. The preliminary written comments move the Company closer to alignment with FDA on the design of a single Phase 3 registration trial for the approval of MAT2203. At the FDA’s invitation, Matinas is planning a meeting early in the first quarter of 2024 to discuss and finalize the Phase 3 protocol and position MAT2203 to commence Phase 3 as soon as possible thereafter.
“We remain grateful to FDA for the ongoing constructive dialogue around the Phase 3 program for MAT2203 and we believe we share the common goal of positioning MAT2203 for review and approval while minimizing regulatory risk,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “The latest feedback from FDA has moved us closer to agreement, and we believe accepting the FDA’s invitation for a meeting in early 2024 will be the final step in achieving full alignment with FDA.
“Our goal remains to design and implement a feasible and interpretable Phase 3 clinical trial leading to an approval that will meet a significant unmet medical need for patients. We believe that this could lead to a promising commercial opportunity for Matinas. The data generated in our ongoing Expanded Access/Compassionate Use Access program has continued to increase our optimism for our Phase 3 study and its probability of success and has been impactful in our discussions with the FDA,” he added. “We remain engaged in an active partnership process and have updated these parties as we continue to engage with the FDA. Importantly, we believe that achieving complete protocol alignment is not a prerequisite to consummating a potential transaction.”
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.
Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. Matinas’ LNC platform provides oral delivery of amphotericin B without the significant nephrotoxicity otherwise associated with IV-delivered formulations. MAT2203 also allows for safe, longer-term use outside of a hospital setting, which could have substantial favorable pharmacoeconomic impact. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated as an oral step-down monotherapy treatment following IV amphotericin B in a single pivotal Phase 3 study in the treatment of aspergillosis in persons with limited treatment options who are unable to be treated with azoles for reasons related to drug-drug interactions, resistance or for whom these antifungal agents are unable to be used for other clinical reasons.
In addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can potentially provide solutions to many of the challenges standing in the way of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos such as small oligonucleotides such as ASOs and siRNA. The combination of its unique mechanism of action and flexibility with routes of administration (including oral) positions Matinas’ LNC technology to potentially become a preferred next-generation orally available intracellular drug delivery platform. For more information, please visit www.matinasbiopharma.com.
Forward-looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, the potential of our LNC platform technology, and the future development of its product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and partnership opportunities for its products, including MAT2203, or platform delivery technologies on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to continue as a going concern, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s product candidates are all in a development stage and are not available for sale or use.
Investor Contact
LHA Investor Relations
Jody Cain
Jcain@lhai.com
310-691-7100
FAQ
What is the latest update from FDA regarding Matinas BioPharma Holdings, Inc. (MTNB) and MAT2203?
When is Matinas BioPharma Holdings, Inc. (MTNB) planning to meet with the FDA to discuss and finalize the Phase 3 protocol for MAT2203?
What is the goal of Matinas BioPharma Holdings, Inc. (MTNB) regarding the Phase 3 clinical trial for MAT2203?
Are partnership discussions ongoing for Matinas BioPharma Holdings, Inc. (MTNB) and MAT2203?
