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Therapeutics


Figure 2 Phase I clinical trial of a combination of azidothymidine and colistin: Helperby Therapeutics is in clinical development with a combination of two antimicrobials, namely azidothymidine(a new antibacterial class in clinical development) and an old antibiotic colistin which is considered to be the last resort for Gram-negative bacterial infections. This combination is active against all three WHO Critical Priority pathogens. The figure is a cartoon of the serum levels in a Phase 1 Pharmacokinetics Clinical Trial in 27 volunteers. Doses of the drugs were no higher than approved doses in the case of AZT, and were lower than doses which are often used in the clinic for colistin. Concentrations in sera were observed which, in combination, are bactericidal


effluent into river systems, thus contaminating the environment. Stewardship requires local guidelines and teams


of trained professionals. In UK, for patients with life-threatening infections, prompt, effective antibi- otic treatment must be started within one hour, or as soon as possible. Broad-spectrum antibiotics should be avoided and careful documentation should be recorded in the patient’s clinical records. For prophylaxis, a single dose is recommended, or more doses in special circumstances. Once susceptibility is known, switch to the cor-


rect antibiotic. Ultra-rapid antibiotic sensitivity tests which give results in less than one hour would be helpful. National and local stewardship guide- lines and regular reviews will be needed. Education of patients, and their clinical and non-clinical care givers, should be a priority in the fight against AMR. The United Nations has recommended that


every country plays its part in the control of AMR, and improved stewardship is an important compo- nent of these efforts. A global stewardship regulatory authority is a


logical next step. However, at the present time it is unlikely to be a practical solution. For example, internet purchase of antibiotics, particularly by people with poor access to these drugs, sale of


Drug Discovery World Summer 2018


antibiotics over the counter, provision of antibi- otics by people who are not medically qualified, poor sanitation, poor education, war and inade- quate infrastructure are significant hurdles. Whether countries will adopt effective stewardship schemes by 2050 is an open question. In the first two years since the UN resolution, there has not been an obvious slowing of, for example, the epi- demic spread of colistin resistance. This does not bode well for the global control of the spread of AMR.


What should the pharmaceutical industry do to tackle the AMR problem? It is easy to blame the large pharmaceutical compa- nies for failing to develop new antibiotics. However, it costs huge sums of money to discover, develop and then market an antibiotic. It is well known that the unit price for a course of treatment for a life-threatening infection with a new antibiot- ic is lower (from 10-1,000 fold) than other new drugs, such as new cancer or immunologic treat- ments. Big pharmaceutical companies are not char- ities and answer to shareholders who require prof- its. What is clear now is that they will not come to the rescue (with a small number of exceptions), unless the financial rewards are realistic.


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