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This clinical trial used a 1:1:2 randomization between lower dose rNAPc2, higher dose rNAPc2 and standard of care heparin that was delivered in prophylactic doses in 93% of the patients. rNAPc2 patients received three sub-cutaneous (SC) doses.
Lead Product(s):
Recombinant Nematode Anticoagulant Protein c2
rNAPc2 (AB201) is a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases and a potent, selective inhibitor of tissue factor (TF).
Recombinant nematode anticoagulant protein c2 (rNAPc2) is a novel and potent inhibitor of fVIIa/TF that may improve current therapeutic strategies used in COVID-19.
The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women use in HIV prevention.
rNAPc2 is a recombinant protein therapeutic being developed by ARCA as a potential treatment for COVID-19 and other severe viral infections. Deal provides exclusive world-wide patent rights to the use of rNAPc2 as a potential treatment for COVID-19 and other indications.
Lead Product(s):
Recombinant Nematode Anticoagulant Protein c2
A total of 56 patients had been recruited and randomised to the STAR trial ("SFX-01 treatment for Acute Respiratory Infections").SFX-01 upregulates the Nrf2 pathway which is part of the natural human defence against inflammatory and oxidative stress.
A preliminary analysis shows no significant difference in the primary endpoint of 28-day mortality (19% azithromycin vs. 19% usual care) There was also no evidence of beneficial effects on the risk of progression to mechanical ventilation or length of hospital stay.
AB201 is the only novel compound being developed for COVID Associated Coagulopathy. The Company intends to initiate a Phase 2b clinical trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020.
Results were published in the Lancet. The paper reported data on 560 people enrolled in the phase 2 portion of the phase 2/3 clinical trial of the ChAdOx1 nCoV-19 vaccine AstraZeneca is developing with the University of Oxford.