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• W4308559080 abstract "Dear Editor, With extensive research, the RNA-based therapeutics remedial process came into the forefront of clinical advancement after completing various trials on siRNA and antisense RNA drugs. This eventually created a benchmark of RNA therapeutics to be used clinically [1]. Several derivatives from RNA, like aptamers, siRNAs, antisense oligonucleotides, and gRNAs, are in clinical use. Moreover, RNA molecules have the advantage of target specificity, which cannot be fulfilled by using proteins or other small molecules [2]. Due to their unique physiological and physicochemical characteristics, the RNA-based therapies are extremely promising than the traditional protein and DNA-based medications. For several years, this field of therapeutics have faced huge limitations regarding its potential and immunogenicity, but the approval of Givosiran and Patisiran has circumvented the challenges. Following this, the domain of RNA-based therapeutics has gained utmost importance, which is clear while surveying the clinical pipeline consisting of several RNA drugs aimed at treating multiple health conditions in different phases of clinical trials [3]. The RNA molecule can target a specific interest gene by complementing its target sequence since most of the genome is translated into non-coding transcripts. However, only a small proportion of it has been medicated by the currently licensed antibodies and drugs. Approximately 85% of the proteins employed for the treatment have designated clefts and pockets, which serve as the binding site for several small molecules. When it moves to the cytosol, the in vitro transcribed messenger RNA can be employed for immunization or protein-replacement therapy, which does not cause any permanent alteration at the genomic level like the DNA-based therapeutics [4]. The aim to modify RNA-based therapeutics started long back. Still, the recent development of the two vaccines against the SARS-CoV-2 virus, namely Comirnaty and Spikevax, increased the momentum of this class of therapeutics. Fomivirsen was the first RNA-based drug approved by the Food and Drug Administration (FDA), followed by sixteen more, including Comirnaty and Spikevax. RNA-based therapeutics have been extremely promising in treating rare diseases ranging from neurological disorders to hepatic diseases. Several oligonucleotide-based drugs are now approved at the end of complete clinical trials to treat several rarely known disorders. Drugs like Givosiran and Patisiran employed for treating hepatic porphyria and transthyretin amyloidosis, respectively, have achieved record market sales [5], showing the potency of RNA-based therapeutics at present. Besides, the COVID-19 viral infection surge has also uplifted the use of RNA-based clinical approaches. For instance, the mRNA-1273 vaccine (Moderna), designed using mRNA technology, was developed within a few days after the availability of the viral sequence. Many more vaccines, like BNT162b2 against the SARS-CoV-2 virus exploiting the mRNA technology, have also been developed [6]. RNA-based therapeutics have gained massive superiority in treating various cardiovascular disorders. One of the siRNA drugs named inclisiran (Leqvio®) that targets the PCSK9 gene has shown significant results in clinical trial studies. Besides, it also highlighted similar potency of downregulating the LDL cholesterol level, similar to the PCSK9 gene inhibitors like evolocumab and alirocumab [5]. Recent advancements in the RNA-based medicines hold great promise for treating a plethora of human diseases by addressing the ultimate pathology rather than the proximate treatment for symptoms as prevalent in the case of conventional therapeutics. To appropriately target the underlying pathophysiological mechanisms of any disease, RNA-based therapeutics are expected to offer more effective outcomes. Moreover, RNA-based therapeutics have received a great deal of attention lately because they are affordable and easier to construct than the conventional protein therapeutics [7]. For example, Wang et al. has commented on the commercialization and investment focus of several companies in this sphere of RNA-based treatment, indicating more effective use of these molecules for treating most diseases in the future [5]. Unprecedented possibilities exist to pave the future generation by developing RNA-based treatments, including the RNA molecules to act as drugs or small molecules. So, the RNA-based therapeutics have the potential to significantly increase the therapeutic targets to treat or eradicate a wide range of health ailments. It has been reported that the market capitalization of public oligonucleotide companies has augmented by 95% (approximately) from 2015 to 2020 [5]. A closer look at the RNA World shows that some medications with unique pharmacological effects, such as siRNAs, miRNA, ASOs, and RNA aptamers, have been applied for medical treatments. One of the derivatives of RNA-based therapeutics is the ASOs or the Antisense oligonucleotides, which are small single-stranded entities consisting of 12–24 nucleotides. They adhere to the Watson-Crick complementary base pairing and can alter the expression of various proteins [8]. Some ASOs like sepofarsen, QR-421a, and QR-112 employed for curing retinal diseases are undergoing clinical trials. Similar to the ASOs are the RNA aptamers, which have a definite three-dimensional architecture with a potential to inhibit several proteins [9]. One of the RNA aptamers, Macugen for example, developed by Eyetech has been used for curing diabetic retinopathy, and it is already available in the market. Similarly, plenty of RNA aptamers are currently undergoing clinical trials. Several RNA therapeutics have received approval from the competent authority for clinical use. Some molecules entered clinical studies after completing the successful preclinical phase (Table 1). Besides single-stranded oligonucleotides, double-stranded oligonucleotide molecules like the siRNA silences several target genes by slicing their target mRNAs [10]. According to Zhang et al., givosiran, lumasiran and patisiran are the three major siRNA-based FDA approved therapeutics. Succeeding them are seven more siRNA drugs that have already reached the Phase III trial [11]. Another class of the RNA-based therapeutic following the RNA interference mechanism is the miRNA mimics of miRNA molecules. The TargomiRs and the MRG-201 are two examples of the miRNA mimic in Phase I and II clinical trials, respectively [12]. For instance, Chakraborty et al. illustrated the preclinical and clinical advancement of miRNA based therapeutics [13]. Also, Huang et al. stated that the noncoding RNA has also gained much attention from the medical perspective. Likewise, MTL-CEBPA and CV8102 are two kinds of noncoding RNA-based therapeutics that are now in Phase I clinical trials [12]. Many more, including gene editing technologies (CRISPR) using gRNA and vaccines have been created to exploit the mRNA technologies; they are currently the key subject of clinical trial studies. Furthermore, evidence also suggests that the contemporary antibiotics mechanistically act on rRNAs to combat severe infections. This in turn motivates the development of novel viable RNA molecules which can serve as an effective therapeutic [2]. Treatments involving RNA-based therapeutics are constructed upon a secure and adaptable foundation that offers almost limitless potential to meet specific unsatisfied clinical requirements. Moreover, the standard medical care for a wide range of diseases will get altered because of this massive development in RNA-based therapeutics [14].Table 1: Various RNA therapeutics, country of origin and their present status.Despite having so many advantages, some hindrances limit the use of RNA-based therapeutics in the medical field. The most significant problem is the delivery of this class of therapeutics to the site of action. The efficiency of the RNA-based therapeutics is also impacted by the random binding of agents with other molecules, the variation in the RNA processing pathway, and the cytotoxicity due to the sequence. However, cutting-edge methodologies have boosted this sphere of treatment lately. For example, some of the modifications in the chemical structure of the nucleic acid like alteration in the nucleobase or the ribose ring are facilitating to overcome the limitations. Evidently, the efficacy of delivering RNA drugs can be enhanced by employing nano-carriers followed by some chemical changes in RNA molecules [4]. The engineering of the RNA-based therapeutics by conjugating them with suitable delivery vehicles and some appropriate chemical modifications in the structure of those RNA molecules will undoubtedly serve as effective treatments for numerous diseases. The structural alterations will undoubtedly make this class of therapeutics more potent than the conventionally used drugs or small molecules. Provenance and peer review Not commissioned, internally peer-reviewed. Please state whether ethical approval was given, by whom and the relevant Judgement's reference number No applicable. Please state any sources of funding for your research None. Author contributions Srijan Chatterjee: Data Curation, Investigation, Writing - Original Draft, Manojit Bhattacharya: Validation and table development, Govindasamy Agoramoorthy: Validation; editing-reviewing. Chiranjib Chakraborty: Conceptualization, Data Curation, Investigation, Writing - Original Draft, Writing - review & editing, All authors critically reviewed and approved the final version of the manuscript. Please state any conflicts of interest All authors report no conflicts of interest relevant to this article. Research registration Unique Identifying number (UIN) Name of the registry: Not applicable Unique Identifying number or registration ID: Not applicable Hyperlink to your specific registration (must be publicly accessible and will be checked): Not applicable Guarantor Professor Chiranjib Chakraborty, Department of Biotechnology, School of Life Science and Biotechnology, Adamas University, Kolkata, West Bengal 700126, India.Email: [email protected] Tel: +91-9871608125. Data statement The data in this correspondence article is not sensitive in nature and is accessible in the public domain. The data is therefore available and not of a confidential nature. Srijan Chatterjee Manojit Bhattacharya Govindasamy Agoramoorthy Chiranjib Chakraborty aDepartment of Biotechnology, School of Life Science and Biotechnology, Adamas University, Kolkata, West Bengal, 700126, India bDepartment of Zoology, Fakir Mohan University, Vyasa Vihar, Balasore, 756020, Odisha, India cCollege of Pharmacy and Health Care, Tajen University, Yanpu, Pingtung, 907, Taiwan E-mail addresses:[email protected]; [email protected]; [email protected]; [email protected]" @default.
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• W4308559080 date "2022-12-01" @default.
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• W4308559080 title "Current status in clinical advancement of RNA therapeutics – Correspondence" @default.
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