Heidelberg, Germany, October 13, 2020 – Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that the first patient has been enrolled in the ASUNCTIS trial. The ASUNCTIS trial is a multi-center, randomized, controlled, open-label phase II trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease. In four treatment arms, three different doses of asunercept plus standard of care versus standard of care alone are being evaluated in a total of 400 patients. Apogenix has received regulatory approval for the ASUNCTIS trial now in both Spain and Russia and will enroll patients in multiple study centers in Madrid and Saint Petersburg, among others.
“The increasing number of COVID-19 infectionsin Europe highlight the urgent need for safe and effective treatment options,” said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. “We are very hopeful that our lead immunotherapy candidate asunercept will prove effective in patients with severe COVID-19disease.”
“The CD95 ligand –which is inhibited by asunercept –plays an important role in the induction of life-threatening lymphopenia and lung epithelial cell death, leading to pneumonia and acute respiratory distress syndrome (ARDS) in COVID-19 patients,” Thomas Hoeger continued. “ Since lymphopenia and ARDS are also complications of other viral infections, asunercept could represent a new therapeutic approach for viral infections beyond COVID-19.”