Periodic Reporting for period 2 - PanaMast (Progressing a non-antibiotic antimicrobial treatment for Bovine Mastitis towards market - PanaMast)
Reporting period: 2018-06-01 to 2019-11-30
Westway Health (WWH) are an innovative Animal Health company based in Galway, Ireland. Our lead product in development is PanaMastTM LC (PanaMast), which represents a breakthrough in the treatment of bovine mastitis, the most economically important infectious disease affecting the dairy industry. PanaMast will dramatically change the way that dairy farmers treat and prevent mastitis and aims to be the world's first non-antibiotic medicine for mastitis treatment, offering a superior clinical outcome and delivering significant financial gains to end-users. This innovative, non-antibiotic technology is effective at killing all bacteria, including antibiotic-resistance bacteria, such as MRSA, whilst preventing the emergence of resistance bacteria. This innovation directly addresses the growing and major European and global problem of antibiotic resistance where novel, effective solutions are urgently required for this $40bn global market.
WWH's main focus is the development of veterinary therapeutics for the treatment of animal health diseases, however this application is part of the much larger societal problem of antibiotic overuse, and antibiotic-resistant bacteria. There is a global crisis looming regarding the emergence and spread of antibiotic-resistant bacteria. In the EU alone, 25,000 people die each year from antibiotic resistance. Overuse of antibiotics is a major factor in the development of resistant bacteria and consequently a rise in the number of human deaths. Reduced use of antibiotics in animal health and the development of alternatives has been advocated. Indeed, the One Health Approach advocated by governments globally views human, animal and environmental health together, where diseases can transmit from one species to another. In fact, the One Health Action Plan against Antimicrobial Resistance (AMR) has been cited in the new H2020 2018-2020 Health funding call with a focus on "the development of new antimicrobials and alternative products for humans and animals".
There needs to be more prudent use of antibiotics and preservation of antibiotics for human use, in a world where 80% of the world's antibiotics are used in animal health. Policies have been already enacted by governments in Denmark and the Netherlands to reduce such usage. The likelihood of future EU-wide action restricting or banning certain classes of antibiotics is high. Outside of the EU, the US FDA have issued a ban on the use of cephalosporins in animal health.
New concepts for novel anti-microbial therapeutics for human and animal health should deploy novel mechanisms of action and ideally, should not allow for a facile emergence of resistance following usage. At a national level, Ireland launched a National Action Plan (iNAP) on AMR for 2017-2020 in October 2017, which contains a range of strategic interventions and activities to reduce the spread of resistance while encouraging the development of novel solutions. Collectively given the aims of our research and the promising results to date, we feel that we are in a position to provide an excellent solution to address this major societal problem. By providing a means of reducing antibiotic usage in the sector which is the largest consumer of antibiotics, we shall conserve existing antibiotics for human usage. Prevention of bacterial resistance to our treatments shall prevent any potential zoonotic transfer of resistance from animals to humans, providing a glimpse into a safe 'post-antibiotic' era.
The overall aim of this H2020 SME Phase 2 project is to bring PanaMast to the point of EU commercial launch. This requires regulatory approval from the European Medicines Agency (EMA) through the submission of a product regulatory dossier requiring information under: Quality, Safety, Efficacy, themes. Thus, the first major project objective is to complete the remaining clinical and commercial aspects of product development to allow for completion and submission of a product regulatory dossier. This is ongoing, and the majority of the work packages (WPs) are involved with these aspects (see flow chart).
The second overall project objective is to ensure effective and efficient commercialisation of PanaMast. We are currently liaising with regulatory agencies and GMP manufacturing companies who will allow for immediate market launch and sale of the product, upon completion of the product regulatory dossier.
WWH's main focus is the development of veterinary therapeutics for the treatment of animal health diseases, however this application is part of the much larger societal problem of antibiotic overuse, and antibiotic-resistant bacteria. There is a global crisis looming regarding the emergence and spread of antibiotic-resistant bacteria. In the EU alone, 25,000 people die each year from antibiotic resistance. Overuse of antibiotics is a major factor in the development of resistant bacteria and consequently a rise in the number of human deaths. Reduced use of antibiotics in animal health and the development of alternatives has been advocated. Indeed, the One Health Approach advocated by governments globally views human, animal and environmental health together, where diseases can transmit from one species to another. In fact, the One Health Action Plan against Antimicrobial Resistance (AMR) has been cited in the new H2020 2018-2020 Health funding call with a focus on "the development of new antimicrobials and alternative products for humans and animals".
There needs to be more prudent use of antibiotics and preservation of antibiotics for human use, in a world where 80% of the world's antibiotics are used in animal health. Policies have been already enacted by governments in Denmark and the Netherlands to reduce such usage. The likelihood of future EU-wide action restricting or banning certain classes of antibiotics is high. Outside of the EU, the US FDA have issued a ban on the use of cephalosporins in animal health.
New concepts for novel anti-microbial therapeutics for human and animal health should deploy novel mechanisms of action and ideally, should not allow for a facile emergence of resistance following usage. At a national level, Ireland launched a National Action Plan (iNAP) on AMR for 2017-2020 in October 2017, which contains a range of strategic interventions and activities to reduce the spread of resistance while encouraging the development of novel solutions. Collectively given the aims of our research and the promising results to date, we feel that we are in a position to provide an excellent solution to address this major societal problem. By providing a means of reducing antibiotic usage in the sector which is the largest consumer of antibiotics, we shall conserve existing antibiotics for human usage. Prevention of bacterial resistance to our treatments shall prevent any potential zoonotic transfer of resistance from animals to humans, providing a glimpse into a safe 'post-antibiotic' era.
The overall aim of this H2020 SME Phase 2 project is to bring PanaMast to the point of EU commercial launch. This requires regulatory approval from the European Medicines Agency (EMA) through the submission of a product regulatory dossier requiring information under: Quality, Safety, Efficacy, themes. Thus, the first major project objective is to complete the remaining clinical and commercial aspects of product development to allow for completion and submission of a product regulatory dossier. This is ongoing, and the majority of the work packages (WPs) are involved with these aspects (see flow chart).
The second overall project objective is to ensure effective and efficient commercialisation of PanaMast. We are currently liaising with regulatory agencies and GMP manufacturing companies who will allow for immediate market launch and sale of the product, upon completion of the product regulatory dossier.
The SME Instrument project has been extremely successful one. We have advanced the development of our novel non-antibiotic mastitis therapeutic, PanaMast LC, to the point of near market launch.
We have shown:
- bacteria are unable to gain resistance to PanaMast, nor to develop a cross-resistance to other antimicrobials
- this product is safe to use and that treated milk does not affect downstream processing activities
- PanaMast LC is highly effective at killing bacterial pathogens in trials. Final trials are ongoing to allow Westway Health to complete the necessary trials to allow submission of a product dossier to the EMA.
Commercially we have advanced the pathway for product launch. We have finalised a production protocol for the GMP manufacture with market analysis completed and marketing materials prepared as part of a market launch strategy.
The results of the project have been disseminated widely during the project: published in peer-reviewed scientific journals, newspapers and websites and discussed at scientific conferences. Westway Health generated a project-specific website and promoted this widely on its various social media platforms.
Based upon the success of this project we are developing an active pipeline for several animal health diseases. We are set to complete a €3m fund-raising round in Q2 2020; this shall allow us to continue to grow the team and to advance our product
We have shown:
- bacteria are unable to gain resistance to PanaMast, nor to develop a cross-resistance to other antimicrobials
- this product is safe to use and that treated milk does not affect downstream processing activities
- PanaMast LC is highly effective at killing bacterial pathogens in trials. Final trials are ongoing to allow Westway Health to complete the necessary trials to allow submission of a product dossier to the EMA.
Commercially we have advanced the pathway for product launch. We have finalised a production protocol for the GMP manufacture with market analysis completed and marketing materials prepared as part of a market launch strategy.
The results of the project have been disseminated widely during the project: published in peer-reviewed scientific journals, newspapers and websites and discussed at scientific conferences. Westway Health generated a project-specific website and promoted this widely on its various social media platforms.
Based upon the success of this project we are developing an active pipeline for several animal health diseases. We are set to complete a €3m fund-raising round in Q2 2020; this shall allow us to continue to grow the team and to advance our product
PanaMast aims to be a truly disruptive product for the treatment of bovine mastitis. Current treatments utilise an intramammary syringe to inject an antibiotic into the infected udder of a cow. To prevent antibiotic residues entering the food chain, treated milk must be discarded for a number of days during and following treatment - this withdrawal period may persist for up to 8.5 days depending on the antibiotic used. Antibiotic-resistance may lead to a secondary treatment being required, causing a further milk withdrawal and economic losses. From a study by Teagasc, it is estimated that each case of mastitis causes a loss of €285 to the farmer.
PanaMast aims to revolutionise the way mastitis is treated. Acting as a broad-spectrum antimicrobial effective against all pathogenic bacteria, including antibiotic-resistant strains. In field trials to date, this has shown excellent efficacy in comparison to existing products. In cases of mastitis caused by S.aureus the effectiveness of current treatments is 5-15%, with culling of the cow the typical outcome. By comparison, treatment with PanaMast has shown an approximate cure rate of 70%. The active ingredients used in PanaMast are established chemicals, and have been proven safe. As such they have been approved by the EMA as not requiring an MRL (maximum residue level). This means that PanaMast aims to become the world's first zero withdrawal mastitis treatment, allowing for an effective treatment where the farmer can sell milk during and immediately following treatment. We estimate farmers will save approximately €150/case of mastitis.
PanaMast aims to revolutionise the way mastitis is treated. Acting as a broad-spectrum antimicrobial effective against all pathogenic bacteria, including antibiotic-resistant strains. In field trials to date, this has shown excellent efficacy in comparison to existing products. In cases of mastitis caused by S.aureus the effectiveness of current treatments is 5-15%, with culling of the cow the typical outcome. By comparison, treatment with PanaMast has shown an approximate cure rate of 70%. The active ingredients used in PanaMast are established chemicals, and have been proven safe. As such they have been approved by the EMA as not requiring an MRL (maximum residue level). This means that PanaMast aims to become the world's first zero withdrawal mastitis treatment, allowing for an effective treatment where the farmer can sell milk during and immediately following treatment. We estimate farmers will save approximately €150/case of mastitis.