KPM Tech-Telcon RF Pharma "HumaneGen Announces Positive Interim Data from Phase 3 Clinical Trial of COVID-19 Treatment"

[Asia Economy Reporter Hyunseok Yoo] Lenzilumab, a novel coronavirus disease 2019 (COVID-19) treatment developed by Humanigen, a U.S. company invested in by KPM Tech and Telcon RF Pharmaceutical, has a higher likelihood of applying for Emergency Use Authorization (EUA) early next year following the announcement of positive interim clinical trial results.

On the 6th (U.S. local time), Humanigen announced the interim results of the Phase 3 clinical trial for the COVID-19 treatment Lenzilumab. In the Phase 3 trial involving hospitalized patients, Lenzilumab showed a 37% higher recovery rate compared to the existing standard COVID-19 treatment methods. Accordingly, the Data Safety Monitoring Board (DSMB) recommended expanding the clinical trial to include approximately 515 patients.

Humanigen evaluates that the positive interim clinical assessment by the DSMB and the recommendation to expand the clinical trial population have increased the likelihood of Lenzilumab's success. Humanigen expects to be able to apply for EUA in the first quarter of next year.

Meanwhile, on the 6th (U.S. local time), Humanigen announced that it signed a Cooperative Research and Development Agreement (CRADA) with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the U.S. Department of Defense. This CRADA will also involve collaboration with the Biomedical Advanced Research and Development Authority (BARDA) under the U.S. Department of Health and Human Services (HHS). Through this agreement, Lenzilumab will receive various support from relevant authorities for manufacturing, regulatory approvals, and other necessary authorizations to expedite EUA approval.

Lenzilumab is Humanigen’s new drug candidate designed to prevent and treat immune overreaction caused by cytokine storms, a major cause of death in COVID-19 patients. Data indicates that up to 89% of COVID-19 patients are at risk of immune overreaction that triggers acute respiratory distress syndrome.

KPM Tech and Telcon RF Pharmaceutical recently secured the domestic and Philippine distribution rights for Lenzilumab from Humanigen.