Table of Contents
Persistent Unmet Need for Treatment Fuels Novel Antiviral/Antibacterial Drug Development
• Ribavirin, the only approved antiviral directed at the human respiratory syncytial virus (RSV), is modestly effective. Variable response, development of resistance and viral breakthrough, along with poor tolerability and suboptimal dosing regimens, however, do not support the regular use of ribavirin.
• Successful commercialisation of next-generation antibodies and the launch of cheaper biosimilar versions of Synagis are likely to result in improved immunoprophylactic therapy for RSV.
• Clinical trials investigating the development of vaccines for the prevention of RSV are ongoing. Market participants strive to overcome challenges associated with incomplete immune response in very naive infants, and strain variability.
Influenza Antivirals and Vaccines
• Antivirals, particularly second and third-generation neuraminidase inhibitors, are quite effective in the treatment of influenza. However, the development of resistance to antivirals remains a key challenge.
• Egg-based vaccines, for the prevention of both seasonal and pandemic influenza, are currently in use.
• The imminent arrival of novel innovative vaccine technologies, in terms of adjuvants, carriers, and drug delivery mechanisms, has resulted in significant sophistication levels in egg-based vaccines for the prevention of seasonal and pandemic influenza.
• Nevertheless, several newer classes of antivirals, cell-based vaccines, and non-invasive drug delivery systems are currently being investigated to improve efficacy and patient compliance.
• The currently available antibacterials directed against uncomplicated urogenital chlamydia are quite effective and offer a therapeutic cure rate of over xx%.
• As the chlamydia trachomatis infection is predominantly asymptomatic, diagnosis of the disease still remains a key challenge. Hence, the majority of the clinical development activity is directed towards the assessment and testing of the disease.
• Clinical pipelines are very dry with few new compounds being investigated for the treatment of chlamydia. Minimal research and development (R&D) activity is carried out in this market segment.
• The currently available antibacterials directed against Neisseria gonorrhoea are moderately effective. The development of resistance to almost every recommended antibiotic for the treatment of gonorrhoea makes treatment complicated.
• Increased assessment of combination therapies and the investigation of newer classes of antibiotics are likely to contribute to significant cure rates of over xx%.
• Cephalosporins, such as ceftriaxone and cefixime, are currently looked upon as the last line of defence for gonorrhoea, despite a few recently reported cases of resistance to these antibiotics.
• Currently, Cempra Inc. is evaluating solithromycin in phase I/II trials for the treatment of bacterial pneumonia, uncomplicated urogenital gonorrhoea, and other sexually transmitted infections (STIs)
Methodology and Scope
• This research service focuses on antibiotic/antibacterial therapeutics for the treatment of infection by blood-borne (sexually transmitted) bacteria, which include chlamydia trachomatis and Neisseria gonorrhoea as well as antiviral therapeutics for infection by vector borne pathogens such as the influenza virus and the human respiratory syncytial virus (RSV).
• A product and pipeline assessment is provided for marketed and investigational products and combination regimens for the treatment of chlamydia trachomatis, Neisseria gonorrhoea, influenza and RSV infections. Segmentation by drug class is provided along with additional supporting information, such as clinical trial timelines, results and epidemiology.
• The information contained in this research service was derived from published sources, including the following: Disease organisation web sites; public health organisation web sites; company publications including annual reports, US Securities and Exchange Commission (SEC) filings, and press releases; government public sources; and published articles in scientific journals.
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