Rovunaptabin was recently evaluated in a randomised, placebo-controlled phase 2 clinical study (BLOC), conducted at 15 sites across five EU countries (NCT05911009). The study enrolled 114 patients with Long COVID and compared the efficacy of two dosage levels of rovunaptabin against placebo control. The study confirmed that rovunaptabin was safe and well tolerated. However, the primary endpoint was not met, possibly due to weaknesses in the study design. which may reflect study design limitations rather than lack of efficacy.
In following post-hoc analyses, significant improvements were observed in various secondary endpoints, including memory function, muscle and body pain. In addition, there was a tendency towards a more gradual increase in FACIT-F response in the two treatment arms.
APTA Therapeutics is currently planning further clinical trials with clinical centres in Europe and anticipates enrolment of first patients towards the end of 2026