review · Human Vaccines & Immunotherapeutics
Antibiotic resistance is rising rapidly, creating an urgent requirement for alternative therapeutic options. Phage therapy represents a promising substitute and has advanced to evaluation in several recent clinical trials. Nonetheless, significant hurdles remain before phage therapies can be integrated routinely into human therapeutic procedures. Key challenges include an absence of appropriate regulatory frameworks and a lack of sufficient pharmacokinetic data regarding phage behaviour in human patients. Preclinical evaluations using diverse animal models serve an essential role in testing phage therapy approaches and determining how these treatments can be adapted successfully for human application. Developing realistic solutions to resolve regulatory and pharmacokinetic limitations is critical to moving this technology forward from laboratory testing into standard clinical practice.
The rapid growth of antibiotic resistance creates an urgent need for viable alternatives to traditional drugs. Phage therapy offers a potential solution for treating resistant infections, but translating experimental treatments into safe human medicines depends on resolving significant gaps in regulatory guidance and clinical drug behaviour.
This research focuses on anti-infective human therapeutics developed by biotechnology companies and clinical researchers. Although phage treatments have reached clinical trials, the technology remains at an intermediate stage of development. Achieving commercialisation and widespread clinical use will require developers and regulatory bodies to establish clear compliance pathways and resolve missing pharmacokinetic safety data.
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The rapid increase in antibiotic resistance presents a dire situation necessitating the need for alternative therapeutic agents. Among the current alternative therapies, phage therapy (PT) is promising. This review extensively summarizes preclinical PT approaches in various in-vivo models. PT has been evaluated in several recent clinical trials. However, there are still several unanswered concerns due to a lack of appropriate regulation and pharmacokinetic data regarding the application of phages in human therapeutic procedures. In this review, we also presented the current state of PT and considered how animal models can be used to adapt these therapies for humans. The development of realistic solutions to circumvent these constraints is critical for advancing this technology.
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DOI: 10.1080/21645515.2023.2175519
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