press release
- Preclinical data from transgenic mouse models demonstrate beneficial effects on a variety of clinical symptoms similar to those observed in human systemic sclerosis.
- The findings of this study may further support future clinical programs.
Mont-Saint-Guibert, Belgium, March 20, 2024, 7:00 a.m. Central European Time – bioscenic (Euronext Brussels and Paris: BIOS), Clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapies presents latest data on arsenic trioxide (ATO) for systemic sclerosis (SSc) at the 8th International Congress .th 2024 World Congress on Systemic Sclerosis. Data were obtained in the laboratory of Yannick Aranoa, MD. Researchers at Cochin Hospital are building additional evidence for the use of her ATO in multiple autoimmune diseases, as observed in various animal models and in a recent pilot clinical trial.
Scientific communication presented by Dr. Anne Cove and Dr. Anne Cove. Allanore demonstrated the efficacy of ATO in Fra2 transgenic mice used as a disease model for symptomatic SSc, a chronic autoimmune disease characterized by multiorgan fibrosis. BioSenic has previously shown that his ATO, a first-in-class specific immunomodulatory drug, has significant therapeutic effects in humans, and the company is conducting clinical trials of several formulations for autoimmune diseases. We are. The researchers further reported that ATO led to significant histological changes in the lungs, a trend toward decreased various fibrotic markers, and a significant reduction in vascular remodeling in the SSc mouse model. The mechanism of action of ATO seems to involve the prominent immune activation reaction characteristic of SSc, especially the involvement of T cells. These positive findings led BioSenic to continue researching his ATO for possible use in SSc.
said Dr. François Rieger, President and CEO of BioSenic Group. “Our previous data, including several animal models of autoimmune diseases and recent phase 2 trials in systemic lupus erythematosus and chronic graft-versus-host disease, demonstrate that our data is effective in a variety of autoimmune diseases with important unmet medical needs. BioSenic’s liquid ATO solution shows significant therapeutic benefits in need. Recent data on systemic sclerosis, another serious autoimmune disease, show that patients affected by this disease have no cure. demonstrated convincing preclinical evidence to support a Phase 2 study of ATO. The safety of products derived from the pharmacologically active ingredient of ATO, including oral formulations (OATO), is well known and FDA’s rapid 505 (b)(2) may follow the regulatory path.”
Understanding the mechanism of action of arsenic on target cells is essential for determining optimal conditions of use and optimal combinations with other agents. Work from several research teams around the world highlights the autoimmune regulatory, antifibrotic, and vascular remodeling properties of arsenic, which could potentially treat lethal lesions in SSc and other autoimmune pathologies. It became clear.
said Dr. Carol Nikko, CSO and COO of BioSenic.: “We are pleased to highlight these results, which complement our previous findings in another preclinical model of non-genetic but inducible SSc. This will provide a consistent picture of the important therapeutic effects that can be expected in human patients” suffering from severe chronic autoimmune diseases with unmet medical needs. ”
The results were announced at the 8th competition.th Last week, the World Congress on Systemic Sclerosis was held in Prague, Czech Republic.
About bioscenic
BioSenic is a leading biotechnology company specializing in the development of clinical assets. From Medcenic’s arsenic trioxide (ATO) platform. Key target indications for autoimmune platforms include graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and now systemic sclerosis (SSc).
Following the merger in October 2022, BioSenic combined the strategic positions and strengths of Medsenic and Bone Therapeutics.Specifically, due to the merger Medsenic/Biosenic will exploit the immunomodulatory properties of ATO/oral ATO (OATO) to develop a completely new arsenal of various anti-inflammatory and anti-autoimmune drugs.
BioSenic is based at the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. For more information, please visit the following URL: http://www.biosenic.com.
About the leading Medsenic/BioSenic technology platforms
of ATO platform We offer derived active products with immunomodulatory properties and fundamental effects on activated cells of the immune system. One direct application is its use in tumor immunology to treat GvHD (graft-versus-host disease) in its chronic, established stages. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Medcenic has had success in Phase 2 trials of its intravenous formulation. Alcimed®, It has orphan drug designation status with the FDA and EMA. The company is working toward an international Phase 3 confirmation study with its new intellectual property-protected OATO formulation. Another selected target is moderate to severe systemic lupus erythematosus (SLE) using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucous membranes, gastrointestinal tract). Systemic sclerosis is now part of Medcenic/Bioscenic’s clinical pipeline. This serious chronic disease negatively affects the skin, lungs, and angiogenesis, and there is currently no effective treatment. Preclinical studies in relevant animal models are positive and provide sufficient rationale to initiate a Phase 2 clinical protocol using a novel immunomodulatory formulation of an API recognized to be active in the immune system .
The company is currently focusing its current research and development and clinical activities on the selective and accelerated development of its autoimmune platform.
Note: The allogeneic cell therapy platform, derived from previously publicly traded company Bone Therapeutics, uses isolated and purified differentiated bone marrow as a starting material for further isolation of passive or active biological subcells. The use of mesenchymal stromal cells (MSCs) may generate new interest. element. Indeed, these cells may provide novel intracellular vesicles that may provide a unique and unique approach to organ repair. BioSenic is currently working to determine new patentable approaches in this complex area of cell therapy.
For more information, please contact us below.
Bioscenic SA
Dr. François Rieger, Chief Executive Officer
Phone number: +33 (0)671 73 31 59
investorrelations@biosenic.com
Inquiries from overseas media:
IB Communications
Neil Hunter / Michelle Boxall
Phone: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / michelle@ibcomms.agency
Inquiries from French investors:
Seito Sei Actifin
Ghislaine Gaspallet
Phone number: +33 (0)1 56 88 11 22
ghislaine.gasparetto@seitosei-actifin.com
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