WhartSep is fitting hospital’s constraints, providing “off-the-shelf” cells that can be stored frozen for years prior to being injected to patients.
The product is classified as an ATMP (Advanced-Therapy Medicinal Product) by the EMA (European Medicines Agency).
Today, treatments in development, such as mAbs/NCEs are facing similar limitations: 1 drug, 1 mode of action, for multiple combined effects pathology.
On the contrary, WhartSep’s biological features show unique advantages, tackling the complexity of septic shock and ARDS, acting on various aspects of the pathology and adapting to the patient’s needs.
WhartSep is in phase I/II entry in septic shock & ARDS
SEPSIS AND SEPTIC SHOCK
Septic shock is a medical emergency: with 50% of mortality rate and growing incidence, is the 10th leading cause of death in the United States and the 1st cause of death in Intensive Care Units and the incidence is 19/100 000 [1]. The majority of affected patients (42.1%) [2] have an infectious source localized in the respiratory system.
However, there is no specific treatment for sepsis, due to the multitude of mechanisms of actions required to treat the pathology and inadequate clinical trial design. There is a huge unmet medical need and it remains an important challenge for biotech companies in this field. WhartSep strategy answers this challenge by an innovative cell therapy and a disruptive way to tackle the full complexity of septic shock with the first drug having three complementary actions (antibacterial effect, inflammatory and immunity modulation, and lung preservation).
[1] Shankar-Hari et al., Epidemiology of sepsis and septic shock in critical care units, 2017
WORSENING OF SEPSIS LEADS TO HIGH MORTALITY AND TO HIGH MORBIDITY RATES
Major unmet medical need
A costly disease with limited solutions
