New adjuvant DNA therapy for management of Neisseria gonorrhea

This report offers a novel drug protocol for the management of Neisseria gonorrhea antimicrobial resistance. The bacteria gonococcus causes urinary tract infections. The development of resistance to many antibacterial drugs is key relevance in health care practice, thus the need for developing this novel drug aims at improving its ability to reduce the ability of antibacterial resistance.

New adjuvant DNA therapy for management of Neisseria gonorrhea
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New adjuvant DNA therapy for management of Neisseria gonorrhea
Introduction
Novel drug protocol is an essential process in the development of drugs. This report
offers a novel drug protocol for the management of Neisseria gonorrhea antimicrobial
resistance. The bacteria gonococcus causes urinary tract infections (Quillin & Seifert, 2018).
The development of resistance to many antibacterial drugs is key relevance in health care
practice, thus the need for developing this novel drug aims at improving its ability to reduce the
ability of antibacterial resistance.
Drug Indication
Infections associated with Neisseria gonorrhea present a broad range of symptoms and
disease which affect the urogenital, conjunctiva ears, anorectal and pharyngeal. Often severe
cases of the disease develop prognosis to initiate gonococcal infections, meningitis among
others. Currently, the two common methods of detection are nonculture and culture tests.
Culture methods are often the better choice of tests, but also nonculture tests offer an accurate
assessment of the bacteria (Cahoon & Seifert, 2011).
The mechanism of antibiotic resistant details the action of drugs being unable to handle
the bacteria. The Neisseria gonorrhea bacteria will keep multiplying thus creating potency to
the patients. This resistance has been through a wide variety of antibiotics. The mechanism of
action of the bacteria overpowers the action of antibiotics (Anderson, Dewenter, Maier &
Seifert, 2014). The common laboratory challenge facing management of Neisseria gonorrhea
is the drug testing procedures. Growing the nutrient culture and later testing for antibacterial
susceptibility tests is not done often hence making the bacteria to be resistance more often thus
developing reducing its effectiveness.
The occurrence of resistance to common drugs for management of Neisseria gonorrhea
is the greatest public health concern. The hesitance of the common drugs has regulated on the
absence of an effective treatment option for managing gonococcal infections. Emergence of
high reassurance to drugs has led to emergence of conventional drug management to be
introduced to manage gonococcal treatment (Caini et al., 2014).
The development of antibiotic resistance in clinical settings is impacting on the delivery
of effective treatment of the disease. Often resistance is achieved through genetic means and
manifested in the biochemical pathway through target modification processes such as the
acquisition of multidrug pumps or target expressions, (Giedraitienė et al., 2011). The rise of
resistant pathogens is a growing public health concern coupled with high mortality rates due to
the lack of effectiveness of drugs is of great concern.

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The current spread of antibiotic resistance is a critical evolutionary process which needs
urgent consideration, hence necessitating sustainable therapy for the management. Often
bacteria are treated using antibiotics. However, most of this has developed resistance leading to
lack of efficacy and hence no positive clinical outcome.
Despite the attributes of antimicrobial resistance, discovery and development of new
drugs have waned over the years. Currently, most of the products are produced from microbial
natural products through approaches on the semi-synthetic fermentation process of products.
Over recent years, the development of Neisseria gonorrhea drugs has focussed on the tailoring
of the core scaffolds with the aim of generating second and third generation drugs (Fischbach
& Walsh, 2009). Despite this, there is a renewed effort of using target-based strategies to
produce drugs that offer disruption on the specific cellular process of the pathogen.
Neisseria gonorrhea description
Neisseria gonorrhea is a gram-positive bacteria sexually transmitted as a form of
genitourinary infection and other gonoccocal diseases. It has a positive oxidizing action and
aerobic. It survives with neutrophils and exhibits antigenic variation from a process of
recombining its surface and pili proteins which offer interactions on the immune system.
The microbial assessment of Neisseria gonorrhea is described as fastidious gram-
negative bacteria which require supplementation of nutrient when grown in laboratory using
cultures. It is a fulculatitive intracellular nonspore forming with abilities to switch its motility
and obligate aerobically.
The associative antigenic variation of Neisseria gonorrhea is that it evades the immune
system through antigenic variation which allows it to recombine its individual genes and make
changes on the antigenic determinants and acquiring new DNA making it resistant to the
common drug management (Detels et al., 2011).
Being a gram-negative bacteria, Neisseria gonorrhea, it protecting itself using
nondefense mechanism offering a complementary system. Various system processes have been
shown to activate the system, this all result in activation of the complementary proteins. The
mechanism Neisseria gonorrhea has built allows it to offer resistance to its body (Anderson &
Seifert, 2011).
The new drug therapy mechanism of action
The mechanism of action of this novel drug is unique in that it offers inhibition on the
microbial synthesis is through the arrest of the cleaved covalent and complementary proteins
and leads to the formation of fused circular DNA acquiring biosynthesis process. The novel
mechanism entails inhibiting the bacterial type II linked to the topoisomerases. The inhibition

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of the microbial synthesis allows arresting the cleaved complex covalent gyrase and leads to
the formation of a fused circular which is needed in the biosynthesis process, thus inhibiting
the bacteria from rapid progression.
Source of chemical matter
The adjuvant DNA drug is a novel drug made from the antimicrobial powder. The
composition of this novel drug has a stabilized silver antimicrobial composition which has the
ability for topical applications. This silver combination was obtained from two solutions with
one set solution having silver cation while the other has anion compound forming the two
solutions. The silver solution is mixed with the amorphous compositions. Other stabilizing
agents are added in various stages.
This novelty presents amorphous compositions which are used as delivery vehicles for
continuous release of stabilized antimicrobial silver salt. The novel drug acts on the bacterial
inhibition of type II topoisomerase cutting both strands in a simultaneous.
High-Throughput Screening approach
This novel drug discovery will utilize High Throughput screening approach process. It
entails screening assay in large biological modulators with effectors and selected specific
targets of the novel drug. The use of HTS essays is essential in for screening various genomics,
proteins and peptide libraries. Its main goal is to accelerate the discovery of the drugs. The goal
of HTS is to facilitate acceleration of the drug discovery through screening of large libraries at
a higher rate.
It is of great significance due to the parallel and combinational synthesis of the
chemical generated in the vast novel drug compound. It is essential in characterizing the
metabolic pharmacodynamics and to elaborate on the data of the new drug. HTS technology is
preferential due to its nature of cost-effective drug development. The HTS technology can be
utilized in various stages of drug development, management of the compound, development of
assay and library screening process (Gómez-Bombarelli et al., 2016).
The HTS technology will be effective in identifying the target sites for the compound,
thus being attributed to being more focus and precision. Further, this technology will be crucial
in assessing the chemical synthesis of the drug. In this process, the HTS will be performed
using miniaturized cell-based assays. They enable the screening of chemical libraries for
various biological molecules present. As this drug acts on the surface, maintenance of cellular
cell function is fundamental which influence cell behavior (Chan 2015).
Preclinical developments
This novel drug will be undertaken through clinical trials. These include phase, I, II, III

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and IV. The clinical trial is essential in collecting information on the safety and efficacy of the
new drug. The drug testing process will be initiated in the lab after extensive laboratory
research which often various episodes of experimental both on animals and human cells.
Phase I
The novel drug will be subjected to phase I where the novel drug will be assessed on its
safety. This phase will take a longer duration of time running into months while working with a
smaller group number of subjects. This stage is determined at experimenting and seeing the
effects of the drugs on human based on its absorption, metabolism, and excretion. Further sides
effects of the novel drug will be investigated in this phase.
Phase II
During phase two clinical trials, the efficacy of the novel drug will be tested. It will take
several months and it will use larger subjects. This phase will entail randomized trials for the
drugs involving two groups of subjects receiving the novel drug, while the second group acting
as a control receiving a standard treatment of placebo. This study will incorporate blinding so
as the subjects do know which treatment is being offered. This is geared towards offering the
relative safety of the drug and how effective it is.
Phase III
This phase will entail several people being used as subjects. The subjects will range
from 100 to several thousand patients. This is a large scale testing which can last for a longer
duration of time. This phase offers more insights regarding the drug effectiveness, the
associated benefits and any occurrence of adverse reactions. Upon successful implementation
of this phase, the request for approval under the FDA can be requested for market entry.
The end of the 3 phases will be essential for the new adjuvant recombinant drug for
Neisseria gonorrhea. The duration of the development up to testing will inform a significant
amount of time.
Conclusion
The new novel drug adjuvant DNA therapy offers a unique mechanism of action on anti
microbial resistance of Neisseria gonorrhoea. The drug acts on the proteins and create
increased potency on managing the causative bacteria. This is an improvement from the latter
drugs indications which are prone to resistance. The new drug has the ability to survive various
antigenic mutations of the disease hence making it a more reliable drug for management of
Neisseria gonorrhoea. Its action of biosyntheses mechanism offers great advantage compared
to other drugs. Thus novel development of this new drug will have tremendous impact on the
management of the anti microbial Neisseria gonorrhoea strain.

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References
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