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Preclinical Studies

exRNA Therapeutics preclinical lab facility is fully compliant with regulatory guidelines, ensuring the highest standards in research excellence. Our lab is equipped with cutting -edge tools for comprehensive preclinical testing, including advanced molecular and cellular analysis. We conduct rigorous toxicology studies to evaluate the safety and efficacy of our products. Additionally, our CPCSEA certified animal house facility adheres to ethical standards, providing a controlled environment for in vivo testing. exRNA Therapeutics is dedicated to developing innovative and safe biotechnological solutions.

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Biotransformation of G1 drug via Activation of Cytochrome P450 as well as inhibition of TNF-alpha in the Plasma sample


Preclinical division

exRNA Therapeutic Ltd. Bodh Gaya; Gaya Bihar


Summary of Invention

Cytochrome P450 represents a family of isozymes responsible for biotransformation of many drugs via oxidation.  Drug metabolism via the cytochrome P450 system has emerged as an important determinant in the occurrence of several drug-drug interactions. Based on the various scientific evidences, this study initiated the administration of G1 drug through intranasal route in the human subject and Plasma samples were collected before and after administration of G1 drugs after 72 hours. The finding suggested that the Cytochrome P450 enzyme activity was significantly increased along with highly significant decreased inflammation via decreased the TNF-alpha level after treatment with G1 through intranasal route at different time intervals. The finding clearly indicates that the drug G1 showed the anti-inflammatory property and did not cause the drug-drug interaction during metabolism in human subject.



Untitled design
Untitled design

Conclusion

After administration of ASO drug through the nasal route, the Cytokines parameter (TNF alpha ) decreased along with increased cytochrome P450 drug in the plasma of the human sample. The increased Cytochrome P450 level clearly indicates that the drug did not cause drug- drug interaction along with decreased inflammatory response.


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Efficacy Studies




Comparative Efficacy of G1 drug in Carrageenan induced acute inflammation arthritis model


Preclinical division

exRNA Therapeutic Ltd. Bodh Gaya; Gaya Bihar


Summary of the study

The aim of the present investigation was  to determine the efficacy of G1 drug in carrageenan induced  acute inflammation as arthritis model in rat model.Total 18 male rats were selected and divided into three groups of six rats each. The arthritis was induced by administration of carrageenan at dose level of 10 ml/ Kg body weight (1.0%) through subcutaneous route for six days The model was confirmed by knee diameter as well as walk beam test performed in all groups. After confirmation of the model, immediate treatment was started with G1 for 14 days through a subcutaneous route on alternate day. The knee diameter and walk beam test was performed per day during treatment.  The gross morphological examination was performed by photograph.At the end blood samples were collected and performed the C-reactive protein and cytokines parameters as well as some biochemical parameters in the plasma samples of each group. The knee diameter along with walk beam test was found significantly improved along with significant decreased the CRP and TNF alpha level as well as improved the biochemical parameters  (albumin and total protein levels) in G1 treated group as compared to arthritis induced group after 14 days treatment and these levels were revert come back almost to control group. 


Arthritis Induced
Arthritis Induced
Screenshot from_2024_06_28_12_42_38
Screenshot from_2024_06_28_12_42_38

Conclusion

On the basis of above finding, it is clear suggesting that the G1 drug significantly improved knee diameter along with reduced inflammation by reducing C-reactive protein and decreased cytokine parameter (TNF alpha) in arthritis induced by carrageenan. The drug is most effective in the management of inflammation during arthritis.

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Projects

In vitro dermal absorption or penetration study test itemexRP250


The objective of present study was to evaluate the comparative efficacy study of exosome base product EXR-CKD and other market product Nefrosave Forte 650 in adenine induced CKD rat model. On the basis of experimental data it was found that ex-R CKD through oral route is more effective and preventive than market product Nefrosave forte 650 mg to manage and improve chronic renal diseases in animal rats


Comparative anti inflammatory study of exRNA other market drug adalimumab in carrageenan - induced paw edema in wistar rat


The objective of the present study was to compare the anti-

inflammatory property of ExRNA and Adalimumab on rat hind paw edema using a carrageenan-induced acute inflammatory model. Carrageenan is a strong chemical use for the release of inflammatory and proinflammatory mediators (prostaglandins, leukotrienes, histamine, bradykinin, TNFOa, etc). Oral administration of Ex-RNA significantly downregulated the pro-inflammatory cytokines while upregulated the anti-inflammatory cytokines


Therapeutic effect of exRNA drug in alternation of biochemicals & molecular changes in Alzheimer induced rat model


Alzheimer's disease (AD) is a chronic neurodegenerative disease categorized by the deficiency in the cognition and memory. Approximately 50 million people have AD, which is categorized by the deficiency in cognition, memory and other kinds of cognitive dissension. The objective of present study was to evaluate the "therapeutic effect of exRNA drug in alteration of biochemical, neuroinflammation & molecular changes in Alzheimer induced rat model

On the basis of experimental data it is clear that exRNA drugs excerted neuroprotective effect against ammonium chloride neurotoxicity and behavioral parameters including cognitive deficits the biochemical changes were reversed through correction of oxidative stress with enhancement of antioxidant and amelioration of anti biomarkers in neuronal cells


Potential effect of P3 drug on biochemical METASTASIS and inflammatory parameter BENZO[A] PYRENE induced lung cancer in rat model


The aim is to present a study to evaluate the efficacy of P3 drug in Benzo[A]pyrene induced non-small cell lung carcinoma (NSCLC) induced in rat model. On the basis of above finding it is clear suggesting that P3 drug at dose level 500 microgram showed a well measured in vivo investigation show a beneficial action toward B[a]P - Provoked lung cancer and inflammatory - oxidative damage in the human DNA .henceforth , this preliminary data recommend that P3 drug is a promising chemoprevention candidate for lung cancer . The drug showed excellent antitumor activity as well as anti-inflammatory and antimetastatic activity

Therapeutic effect of exRNA drug in acetic acid - induced colitis in female wistar rats


The objective of the present study was to evaluate the efficacy study of Ex RNA (1.0 mg/ml) ulcerative colitis induced rat model

On the basis of this experimental study , on the basis of above finding it clear suggesting that bacterial based exome exRNA is effective for management of Ulcerative Colitis induced by administration of acetic acid based on reduction of inflammatory parameters along with improved the biochemical parameter and increased antioxidant level and reduced oxidative stress


Acute intravenous study of test item P3 in adult sprague dawley (SD) rats


The primary objective of the present study was to determine the acute intravenous toxicity study of test item P3 in sprague dawley rat. On the basis of above parameters it is concluded that the test item P3 was found toxic safe at dose level 10 ml/kg body weight (1.0ml/kg) through intravenous route during acute intravenous toxicity based on mortality , gross organ weight clinical sign of toxicity and necropsy and histopathological analysis

Protective effect of exRNA drug in multistressior induced oxidative stress and behavioral changes in irritable bowel syndrome rat model

Stress exposure is a major risk factor for the development of IBS. The objective of the present study was to evaluate the efficacy of exRNA (1.0 mg/ml) through oral and intravenous in multi stress induced IBS rat model. On the basis of above findings it is clear suggesting that multi-0 factorial stress causes the adverse effect on biochemical and enzymatic parameters along with altered the neurological behavior with inflammatory response and oxidative stress during irritable bowel syndrome. These parameters along with decreased oxidative stress and reduced the inflammatory response by administration of bacterial based exosome drug ex RNA through oral route and intravenous route . The drug showed the better therapeutic effect through oral route than intravenous route based on improvement in biochemical , oxidative stress as well as neurological behavior pattern and inflammatory parameters

Dose range finding ( DRF) study of test item P3 in adult sprague dawley (SD) rats


The primary objective of the present study was to establish dose response and provide the data to appropriate dose selection of test item "PS '' for regulatory studies. Dose range finding Maximum tolerance dose is not a regulatory base study but it is basic information about the dose selection of test substance for regulatory studies on the rodents. This study was conducted in Sprague dawley rat. On the basis of above parameters , it is conducted that the test item P3 was found to be safe at dose level 10 ml/kg body weight ( 1.0mg/ml 100 g ) based on mortality gross organ weight , clinical signs of toxicity and based on histological analysis for daily dose organ weight , clinical sign of toxicity and bas ed on histological analysis daily scope for up to 14 days based on dose range finding study in rodent model

Extracellular RNA ( exRNA) as a Novel Drug delivery system in Isoproterenol (ISO) Induced myocardial infarction (MI) im male rats : a comparative analysis of intravenous vs oral route of exRNA drug


Extracellular vesicles (EVs) have received increasing attention as potential noninvasive diagnostic and therapeutic biomarkers for various diseases. In addition, non-coding RNAs, such as microRNAs (miRNAs), have attracted much attention as potential biomarkers in the encapsulated extracellular-vesicle (EV) form. EVs are bilayer-based lipids with heterogeneous populations of varying sizes and compositions. The EV-mediated transport of contents, which includes proteins, lipids, and nucleic acids, has attracted attention as a DDS through intracellular communication So keeping this view, we have tried to determined comparative efficacy of exRNA drug through oral as well as intranasal route (IN) in isoproterenol (ISO) induced myocardial infarction (MI) rat model.

On the basis of complete analysis, it is clear indicating that isoproterenol (ISO) causes the severe inflammation in cardiac tissue which leads to myocardial infarction due to generation of ROS along with up regulation of pro-inflammatory cytokines along with increased extracellular matrix (ECM) with cardiac fibrosis. These changes in cardiac tissue can be prevented by new extracellular vesicle drug exRNA drug which showed the excellent properties via inhibiting the excessive free radical generation along with increased the endogenous antioxidant system and decreased the pro-inflammatory cytokines with fibrosis in heart tissue during myocardial infarction/ cardiac fibrosis through intravenous as well as oral route therapy. The drug acts as prophylactic in clinical therapy through both routes.


Therapeutic role of Bacterial derived exosome based exRNA drug in pilocarpine induced epilepsy wistar rat model


The aim of this study was to evaluate the therapeutic role of the bacterial derived exosome in pilocarpine induced epileptic rat model. The epilepsy model was developed in animals by

i.p administration of pilocarpine in rat model. Based on the above findings, it is clear proving that bacterial derived non -vascular exomere molecule exRNA drug showed the anti-epileptic property which is equivalent to standard drug phenytoin based on the significant recovered in the hematological and biochemical parameters along with improvement in the endogenous antioxidant enzymes.

The bacterial derived non-vascular exRNA drug also showed the therapeutic effect against the impaired GABA functioning which is associated with the etiology and maintenance of acute and chronic stress, anxiety disorders and sleep disturbances due to excitation and inhibition of neurons cells under epilepsy condition. The drug also plays a significant role in the management of cholinergic modulation in brain disorders. The drug showed the anti-epileptic, anti-inflammatory and antioxidant property due to non -vascular exomere small molecule which easily penetrate the blood brain barrier and improved the neuron cells, oxidative stress and imbalance the antioxidant system during the epilepsy condition


Protective effect of exosome exRNA drug & its comparison with risperidone in ketamine induced schizophrenia ( psychosis) in rat model: possible behavior , biochemical , neurochemical and cellular alterations


Extracellular vesicles (EVs) have received increasing attention as potential non-invasive diagnostic and therapeutic biomarkers for various diseases. One of the potential areas of use of EVs as biomarkers is the central nervous system (CNS), in particular the brain, because EVs can cross the blood-brain barrier. So keeping this view, to investigate the protective effect of bacterial derived exosome exRNA drug and its comparison with standard drug risperidone in ketamine induced schizophrenia rat model.

Based on above findings it is suggesting that exRNA drugs act as antipsychotic drugs which is almost equivalent to standard drug risperidone which improves the neurotransmitters by reducing the GABA and Serotonin along with improvement in the neurological behavior tests. The exRNA is more potent in the term of antioxidant and anti-inflammatory drug in comparison to risperidone by reducing more free radical generation along with increased antioxidant enzymatic levels (CAT, GSH) with reduction of cytokine level (IL-8, TNF-alpha, NF-kB and IL-1 beta) and Neutrophil/Lymphocyte ratio level during psychiatric disorders


Cardioprotective role of exosome exRNA drug in DOXORUBICIN induced cardiotoxicity in rat models


The clinical use of doxorubicin (DOX) is challenged by its incremental dose-related cardiotoxicity. The aim of this study was to investigate the therapeutic role of bacterial derived exosomes against doxorubicin induced cardiotoxicity(DIC) in rat models. These findings concluded that exRNA drugs could protect against DOX-induced cardiac rhythm anomalies, inflammatory mediators amplification, and deteriorated antioxidant activities as evidence of diminished cardiac injury markers, corrected ECG changes, HR improvement, and BP stabilization. exRNA drugs may represent a novel approach to protect patients taking DOX. The suggested mechanisms underlying of exRNA cardioprotective phenomenon through inflammatory reaction reduction as well as the boosting up the antioxidant activities