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Apogenix’ Asunercept Demonstrates Efficacy in Phase II Trial

Apogenix’ Asunercept Demonstrates Efficacy in Phase II Trial for the Treatment

of Hospitalized COVID-19 Patients

  • Clinical efficacydemonstratedfor allasunercept dose groups

  • Statistically significant faster clinical recoveryfor combined treatment groups compared to controlgroup

  • Excellent safety profile of asunercept confirmed

  • Pivotal phase III studyinitiated

Heidelberg, Germany, October 19, 2022 – Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that asunercept showed statistically significant benefits for hospitalized COVID-19 patients in the ASUNCTIS trial. The open-label multi-centerphase II trial investigatedefficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease. COVID-19 patients were randomized equally intofour study arms, receiving 25, 100, or400 mg asunercept(once weekly, i.v.) on top of standard of care (SOC), respectively, or SOC alone.

Efficacy was assessed against theWHO-suggested endpoints, includingtime to clinical improvement according to WHO scale and mortality. The results show strong trends for clinical efficacy in all treatmentgroups, indicating a robust activity of asunercept. Consistently, patients showed faster clinical improvement by approximately 40 %compared to the control group(8-9 days for the three different treatment groups vs. 13 days with SOC). The combined asunerceptdose groups (25, 100 and 400 mg arms) revealed statistically significant faster clinical improvement compared to SOC group (p= 0.038; HR=1.37).Statistical significance was closely missed when comparing the individual treatment groups with SOC group.

Furthermore, the pre-specified analysis of patients with WHO score 4(n=342) at the beginning of the trial showedan approximately 40 %faster clinical improvement in all asunercept groupscompared to control. In thesepatients, astatistically significant clinical benefit for the 100mg asunercept group (n=83) could be achieved (p=0.044; HR=1.53). All patients receiving asunerceptshowed a marked reduction of all-cause mortality at all time points and for each dose compared to patients receiving SOC.

Furthermore, asunerceptreduces the time to recovery from lymphopenia, confirming its presumed mechanism of action. As the extent of lymphopenia correlates with severityof the COVID-19 disease, asunercept accelerates recovery from disease.

Safety in all asunercept plusSOC treatment arms was comparable to the SOC arm, confirming the favorable safety profile of asunercept observed inall previous clinical trials. No trend or pattern was identified among serious and non-serious adverse events across all treatment arms. Apogenix intends to publish detailed results from this study in a peer-reviewed journal.

Univ.-Prof. Felix JF Herth, MD, PhD, Chairman and Head Department of Pneumology and Critical Care Medicine at Thoraxklinik University of Heidelberg and Chairman of the Data Safety Monitoring Board (DSMB) of the ASUNCTIS trial, commented: “Despite some progress in the treatment of hospitalized COVID-19 patients requiring additional oxygen, there still remains a high unmet medical need for this patient group. Asunercept is a novel immune-modulating treatment approach which seems to work independently of COVID-19 strains. It combines an excellent safety profile with encouraging efficacy data, warranting the advancement of clinical development and initiation of a pivotal phase III study.”

Thomas Hoeger, PhD, Chief Executive Officer of Apogenix, said: “We are very pleased to see asunercept displaying a robust efficacy and favorable safety profile in the ASUNCTIS trial. Asunercept is expected to prevent the death of immune and lung cells leading to lymphopenia and acute respiratory distress syndrome, thus reducing the number of COVID-19 patients who require intensive care or even die from this disease. Based on our promising phase II results and given the high need for effective COVID-19 medication in hospitalized patients, we are initiating a pivotal phase III trial (ASUCOV) with asunercept to confirm the encouraging results in a larger number of patients.”

The ASUCOV pivotal trial and related activities are funded with 20.7m EUR by the German Federal Government through grant number 16LW0102 as well as by Apogenix’ leading investor dievini Hopp BioTech Holding GmbH & Co. KG. All responsibility for the conduct of this project of this work lies with Apogenix.


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