exRNA Pipeline 2024
July 1, 2024
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Table of content
Pipeline
Drug’s overview
Autoimmune Disorders
Neurodevelopment/ Neurodegeneration
Female Infertility
Male Infertility
Appendix
exRNA Therapeutics Pipeline 2024
Antisense oligonucleotide therapeutics interference or inhibit the RNA translational process within the cell and promote degeneration of proteins associated with disease.
G4 is a single stranded antisense oligonucleotide sequence of 16mer length.
This short, single-stranded DNA nucleotide sequence binds to the target RNA exhibiting RNA interference.
The RNA expression is either enhanced or repressed due to RNA interference mechanism.
Drug's Overview
exRP250
Overview: exRP250, a new drug containing extracellular Ribonucleic Acid (exRNA), is isolated from Bacillus Velezensis through a process of media preparation, incubation, and filtration. It is a biological product which is considered as a new active substance as it is not found in any existing medicinal product or pharmacopeia.
FORM: Spray
Category of Disease: Dermal
Associated disease: Psoriasis
Route of administration: Topical
Mode of action: The exRP250 spray penetrates the skin rapidly, inhibiting keratinocyte proliferation and reducing inflammation by modulating ROS and key pathways. It suppresses Th17/Th1 cells, promotes Th2/Treg responses, and reduces pro-inflammatory cytokines in psoriasis. The drug acts by repressing transcription factors such as nuclear factor κB (NF-κB), activator protein-1 (AP-1), and interferon regulatory factor-3 (IRF-3), all of which are involved in the inflammatory process. The drug also Induces TGF-β and inhibits cyclin-dependent kinases. The drug is absorbed through the skin-gut lymphatic pathway and enters systemic circulation via the lymphatic system.
G4
Overview: G4 is a single stranded antisense oligonucleotide sequence of 16 mer length.The short, single stranded binds to the target RNA exhibiting RNA interference. The RNA expression is either enhanced or repressed due to the RNA interference mechanism.
FORM: Spray
Category of Disease: Neurological Disorder
Associated disease: Autism Spectrum Disorder (ASD)
Route of administration: Intranasal
Mode of action: Drug has the property to show antisense RNA interference activity on disease-causing RNA transcripts and thus inhibiting its activity to show therapeutic effect for Autism Spectrum Disorder(ASD). After treatment with G4 based formulation, it was found highly significant decreased the TNF-𝜶 level.
Autoimmune Disorders
Neurological Disorders
Female Infertility Disorders
Male Infertility Disorders
Appendix
Pre-IND:
exRP250 is an investigational drug currently in the pre-IND phase of development. At this stage, the sponsor is engaged in preliminary interactions with the FDA to seek guidance and feedback on the drug's development plan. The pre-IND process involves submitting a pre-IND meeting request or pre-IND submission to discuss the drug’s proposed clinical trials, including study design, safety assessments, and regulatory requirements. The goal is to address any potential issues early and ensure that the IND application, once submitted, aligns with FDA expectations. Successful navigation of this phase will facilitate a smoother transition into clinical trials and support the advancement of exRP250 towards potential approval and commercialization.
Ayush Mantralaya:
The exRP250 has been granted approval by the Ayush Mantralaya, confirming that it meets the necessary regulatory standards for traditional medicine products. This approval ensures that exRP250 complies with the ministry's guidelines on safety, efficacy, and quality, which are crucial for traditional medicine. As a result, the product is authorized for marketing and use, reflecting its adherence to the rigorous evaluation process established by the Ayush Mantralaya. This certification underscores the product's alignment with regulatory requirements and supports its integration into the traditional medicine market.
Department of Scientific and Industrial Research (DSIR):
exRNA Therapeutics has been granted approval by the Department of Scientific and Industrial Research (DSIR), recognizing the company's commitment to advancing scientific and technological research. This approval signifies that exRNA Therapeutics meets the rigorous standards set by DSIR for R&D activities, including adherence to good practices and substantial contributions to the field. As a result of this approval, exRNA Therapeutics is eligible for various benefits, such as tax exemptions and potential grants, which can support and enhance their ongoing research and development efforts.
