Imiquimod

HOUSTON, Feb. 13, 2024 /PRNewswire/ -- FibroBiologics (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company focused on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials encompassing 150+ patents issued and pending, presented preclinical data that employs human dermal fibroblast (HDF) spheroids to treat an induced mouse model of psoriasis at the 2024 Keystone Symposia for Systemic Autoimmune and Autoinflammatory Diseases during a poster presentation. See the poster "Exploring a Novel Cell-based Therapy Using Human Dermal Fibroblasts in a Mouse Model of Psoriasis" here or on the publications section of the FibroBiologics website. "As part of our IND-enabling experiments for our early discovery phase psoriasis project, our in vivo animal studies have provided evidence that HDF spheroids have both external effects on measures of psoriasis severity in addition to a direct positive impact on reducing autoimmune inflammation," said Dr. Hamid Khoja, Chief Scientific Officer at FibroBiologics. "Cognizant of the high degree of psychological and physiological impact of psoriasis on patients, these findings indicate a potentially promising new direction for developing cell therapy-based alternative psoriasis treatments using fibroblast spheroids." Psoriasis is an autoimmune inflammatory disorder often characterized by the development of plaques and scales on the skin, which in many individuals may lead to psoriatic arthritis. Psoriasis affects more than eight million adults in the United States alone, and FibroBiologics is investigating the therapeutic potential of HDFs for treating this disorder and providing relief to patients. In our study using an imiquimod (IMQ)-induced psoriasis model in C57BL/6J mice, we found that a single intravenous administration of HDF spheroids significantly reduced the severity of psoriatic skin lesions, with a 35% decrease in average Psoriasis Area and Severity Index (PASI) score (p<0.0001). Systemic effects were also evident, as HDF spheroid administration ameliorated IMQ-induced changes in spleen size and lymphocyte and monocyte counts. The ability of HDF spheroids to affect markers of psoriatic inflammation was further explored by co-culturing with human blood-derived monocytes. HDFs inhibited tumor necrosis factor (TNF)-α and interleukin (IL)-17 production in addition to suppressing cytokine-induced dendritic cell maturation by down-regulating CD40, CD80, CD86, and IL-12 and up-regulating inhibitory molecules, including IL-10, IL-1 receptor antagonist (IL-1Ra), and programmed cell death-1 (PD-L1). For more information, please visit FibroBiologics' website or email FibroBiologics at: [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication may contain "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning FibroBiologics' possible or assumed future results of operations, business strategies, debt levels, competitive position, industry environment, potential growth opportunities and the effects of regulation, including whether FibroBiologics will generate returns for stockholders. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth in the Risk Factors section of FibroBiologics' Registration Statement for the Direct Offering filed with the SEC. Copies are available on the SEC's website, . These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) the occurrence of any event, change or other circumstances that could cause the Registration Statement to not become effective; (b) the ability of FibroBiologics to continue to meet Nasdaq listing requirements; (c) the ability to effectively manage the business as a result of the super-voting proxy given to the Board of Directors. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics: Based in Houston, FibroBiologics is a cell therapy, regenerative medicine company developing a pipeline of treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit . Investor Relations: Nic Johnson or Harrison Seidner, Ph.D. Russo Partners 212-845-4242 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected] General Inquiries: [email protected] SOURCE FibroBiologics

In an acute colitis model, data show statistically significant knockdown of elevated levels of serum TNFα, reductions in tissue TNFα mRNA and improvement in disease activity scores In an acute psoriasis model, data show reductions in tissue IL-17A mRNA and improvement in clinical disease markers including skin lesions BEDMINSTER, N.J, Dec. 27, 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 results from a series of in vivo studies demonstrating successful oral delivery of two LNC-formulated small single-strand oligonucleotides that specifically target key inflammatory cytokines TNFα and IL-17A in well-established and validated animal models that mimic acute inflammatory responses seen in human diseases. “These studies demonstrate successful oral delivery and biological activity of two different LNC-formulated small oligonucleotides targeting inflammatory cytokines with reductions in tissue cytokine mRNA in both colitis and psoriasis, along with significant reductions in serum TNFα levels in colitis. Commensurate improvements in clinical disease markers and scores were also documented in both models,” said James Ferguson, M.D., Matinas’ Chief Medical Officer. “While additional study is warranted, the successful oral delivery of small oligonucleotides is very exciting and we believe these data demonstrate how Matinas’ LNC platform could be used for the oral delivery of functional small oligonucleotides with potential therapeutic applications,” Dr. Ferguson added. “Importantly, the unique nature of the particular oligonucleotides evaluated in these studies, which interfere with cytokine synthesis rather than simply targeting the cytokine itself, creates additional opportunities for potential future applications of LNC-delivered therapeutics, either alone or in combination with other therapeutics with different mechanisms of action.” Earlier this year, Matinas established the in vitro potency of these proprietary oligonucleotides and their LNC formulations in knocking down their respective cytokine targets in cultured cells. Both were advanced to in vivo studies to evaluate meaningful biological activity in relevant disease models. Acute Colitis Study (TNFα) A dextran sulfate sodium (DSS)-induced murine colitis model was used to evaluate an orally administered LNC-delivered small oligonucleotide that specifically targets TNFα mRNA synthesis. Colon tissue TNFα mRNA levels, as assessed by quantitative real-time PCR analysis, were lower following orally administered active LNCs, resulting in statistically significant reductions of serum TNFα levels by 37% compared with diseased, but untreated animals. Importantly, clinical disease activity scores at key time points in the studies were also significantly improved with an active LNC formulation. Acute Psoriasis Study (IL-17A) An imiquimod (IMQ)-induced murine psoriasis model was used to evaluate an orally administered, LNC-delivered small oligonucleotide designed to inhibit IL-17A mRNA synthesis, which contributes significantly to the progression of psoriatic skin lesions. Similar to the DSS colitis model, skin tissue levels of IL-17A mRNA in the IMQ psoriasis model were lower with orally administered active LNCs compared with IMQ alone. In this model, while IL-17A serum levels were not expected to change, improvement was demonstrated in clinical disease markers of skin redness and scaling, further validating the biological activity of these small oligonucleotides. Additional tissue and histologic analyses from both studies are ongoing and the Company plans to present these data at future scientific meetings. “We believe that our proprietary encapsulation and oral delivery methods could be applied to other small oligonucleotides, including RNAi therapeutics such as siRNA and antisense oligonucleotides,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “While a variety of methods for administering small oligonucleotides exist, most are primarily directed to the liver, and none provide oral administration and delivery capabilities. The opportunity to orally deliver small oligonucleotides with extra-hepatic targeting could be key differentiating features in rapidly advancing anti-inflammatory therapy. “We plan to further review the data from these inflammatory disease models to determine the best path forward for this program,” he added. “Further study and optimization of these LNC-delivered small oligonucleotides will be required to assess the most appropriate therapeutic targets and the associated magnitude of benefit.” About Matinas BioPharmaMatinas 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 StatementsThis 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 RelationsJody CainJcain@lhai.com310-691-7100