Advancing therapies focused on fortifying and restoring balance to the body's defense mechanisms
When health is compromised by infection, insult, or injury, the body's response can trigger a cascade of immune dysregulation and organ dysfunction, leading to poor patient outcomes. Treatments aimed at modulating these responses, known as host-directed therapeutics (HDTs), have the potential to prevent, reduce or mitigate immediate and long-term harm through promoting a balance of healthy cells, tissue, immune system or organ function.
HDTs by design target universal responses, representing a threat agnostic approach for a variety of health security threats, including pandemics. They offer a significant advantage for pandemic preparedness by eliminating the need for pathogen identification and pathogen specific treatment, which is a critical capability when facing an emerging or previously unknown pathogen. While HDTS may be used for the treatment of non-infectious conditions (e.g., high blood pressure, autoimmune disorders, oncology), they have not been widely applied to health security problems due to perceived challenges in development or ROI. To catalyze broader implementation of HDTs, we are supporting development of new or repurposed drugs, biologics, or devices.
Demonstrate the clinical utility of HDTs, in mitigating severe patient outcomes, (e.g. ARDS and sepsis)
Leverage HDTs to build resilience and restore homeostasis across the care continuum
Sub-type populations most likely to benefit from the HDT
To provide contemporary estimates of the burdens (costs and mortality) associated with acute inpatient Medicare beneficiary admissions for sepsis.
To distinguish characteristics of Medicare beneficiaries who will have an acute inpatient admission for sepsis from those who have an inpatient admission without sepsis, and to describe their further trajectories during and subsequent
To evaluate the impact of sepsis, age, and comorbidities on death following an acute inpatient admission and to model and forecast inpatient and skilled nursing facility costs for Medicare beneficiaries during and
To provide updated information on the burdens of sepsis during acute inpatient admissions for Medicare beneficiaries.
Influenza causes substantial mortality, especially among older persons. Influenza vaccines are rarely more than 50% effective and rarely reach more than half of the US Medicare population...
Host-directed therapeutics targeting immune dysregulation are considered the most promising approach to address the unmet clinical need for acute lung injury...
For this program, the medical countermeasure should be able to address infection via any etiology, and is not limited to one or the other.
Proposals must include prior demonstration and preliminary clinical data to support the use for their intended indication. Additionally, the device should be considered near-translational science, and these AOls are unable to fund exploratory efforts at this time.
We are unable to inform or guide companies on what specific test models to use to collect clinical data.