Nice find YM. IPIX has 3 signed MTA's, any of which could lead to accelerated approval of Brilacidin for COVID-19. I pulled a couple of paragraphs from the FDA update.
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The guidances issued today build on steps the agency has taken to streamline its review and advice process to get studies started as quickly as possible, and they incorporate information provided to individual innovators or researchers over the past several months.
The first guidance, “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,” outlines a more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. The FDA is committed to helping sponsors get potentially effective products into study quickly, while protecting the safety of patients. To that end, the guidance provides sponsors clarity on the types of data and information they should provide to address clinical, nonclinical and quality considerations before submitting an application to initiate studies.
The second guidance, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” provides the FDA’s current recommendations on later stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The guidance outlines critical sponsor considerations such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly). In addition, the guidance helps sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy and monitoring for safety. The FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic.
These guidance documents are supplemented by a variety of ongoing activities and broad agency guidance to support innovative study designs, including master protocols, to test multiple products and multiple populations simultaneously and get answers on safety and efficacy as quickly as possible.
In addition to the FDA’s work to expedite preventative and therapeutic options, the agency is engaged in a public-private partnership with the National Institutes of Health and others to speed the development of COVID-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, which also includes other U.S. and European government partners and more than a dozen biopharmaceutical companies, will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to COVID-19 and future pandemics.
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The guidances issued today build on steps the agency has taken to streamline its review and advice process to get studies started as quickly as possible, and they incorporate information provided to individual innovators or researchers over the past several months.
The first guidance, “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,” outlines a more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. The FDA is committed to helping sponsors get potentially effective products into study quickly, while protecting the safety of patients. To that end, the guidance provides sponsors clarity on the types of data and information they should provide to address clinical, nonclinical and quality considerations before submitting an application to initiate studies.
The second guidance, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” provides the FDA’s current recommendations on later stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The guidance outlines critical sponsor considerations such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly). In addition, the guidance helps sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy and monitoring for safety. The FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic.
These guidance documents are supplemented by a variety of ongoing activities and broad agency guidance to support innovative study designs, including master protocols, to test multiple products and multiple populations simultaneously and get answers on safety and efficacy as quickly as possible.
In addition to the FDA’s work to expedite preventative and therapeutic options, the agency is engaged in a public-private partnership with the National Institutes of Health and others to speed the development of COVID-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, which also includes other U.S. and European government partners and more than a dozen biopharmaceutical companies, will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to COVID-19 and future pandemics.
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