The Company views COVID-19 as a diseases that could potentially transform from a pandemic to an endemic, due to the combination of the vaccine’s efficacy being less than 100% and the refusal of certain populations to get vaccinated. This could potentially result in continuous appearances of various SARS-2 mutations, that in turn may be less responsive to existing vaccines. In its endemic state, COVID-19 could remain for many years to come, and under these conditions the Company expects a demand for safe and effective therapies for the severe/critical patient populations, that may be under-served by existing therapeutics. The Company believes that AllocetraTM, upon regulatory approval, could potentially serve as a “last line” therapy for this patient population.
On February 4th, 2021, the Company reported positive top-line results from Phase II clinical trial that evaluated AllocetraTM in severe and critical COVID-19 patients and provided a program update.
- Phase II + Ib (21 patients treated, 11/21 (52%) with severe illness, 10/21 (48%) with critical illness)
- 0/21 (0%) mortality on day-28
- 19/21 (90.5%) patients recovered and were discharged from the hospital by day-28
- Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.6 days
- 2/21 (9.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28
Data from the investigator-initiated Phase II trial, as well as an audited analysis of the Phase Ib trial are shown below:
Clinical Trial | # Patients Enrolled | Disease Severity | Clinical Outcome | Hospitalization Discharged patients, post Administration of AllocetraTM |
||
---|---|---|---|---|---|---|
Recovered Day 28 |
Mortality Day 28 |
Discharged | Duration (days, avg.) |
|||
Phase Ib | 5 | 2 Severe 3 Critical |
5/5 (100%) | 0/5 (0%) | 5/5 (100%) | 6.6 |
Phase II | 16 | 9 Severe 7 Critical |
14/16 (87.5%) | 0/16 (0%) | 14/16 (87.5%) | 5.3 |
Total | 21 | 11 Severe 10 Critical |
19/21 (90.5%) | 0/21 (0%) | 19/21 (90.5%) | 5.6 |
AllocetraTM is being developed
to treat cytokine storms and multiple organ failure in sepsis patients and in COVID-19 patients