[Asia Economy Reporter Hyunseok Yoo] Humanigen announced on the 15th (U.S. local time) the results of the Compassionate Use Program (CUP) clinical trial for the novel coronavirus infection (COVID-19) treatment using its pipeline drug 'Lenzilumab' conducted at the Mayo Clinic, a U.S. COVID-19 specialized center.
Humanigen published a paper on the results of the Compassionate Use Program (CUP). Compassionate use is a system that permits the use of investigational or unapproved treatments when there is no adequate therapy available for life-threatening, long-term, or severe diseases, and patients would otherwise have to forgo treatment.
The COVID-19 treatment Lenzilumab prevents and treats cytokine storms, which are a major cause of death. It is currently undergoing Phase 3 clinical trials approved by the U.S. FDA, and this CUP was conducted as part of the Phase 3 trial.
According to Humanigen, the clinical trial was conducted on 12 patients. The entire patient group was high-risk, having serious underlying conditions such as ▲advanced age ▲history of smoking ▲cardiovascular disease ▲diabetes ▲chronic kidney disease ▲chronic lung disease ▲high BMI (body mass index), and inflammatory responses.
Among the 12 patients, 4 were in the intensive care unit but moved to general wards after treatment, and 11 patients were discharged. Notably, the average treatment period until discharge and recovery was 5 days, and consistent improvements were observed in oxygen saturation, body temperature, and inflammatory cytokines.
Following the announcement of these results, Humanigen closed at $5.31 on the U.S. over-the-counter market on the 15th (U.S. local time), up 30.15% from the previous day. During the session, the stock price surged to a high of $6.30, a 54.4% increase.
KPM Tech formed a consortium with its affiliate Telcon RF Pharmaceutical and invested approximately 4.9 billion KRW in Humanigen on the 2nd at $0.87 per share. Humanigen is a U.S.-based cell and gene therapy development company.
A representative of the KPM consortium said, “As COVID-19 is spreading seriously worldwide again, the clinical results are encouraging, and we expect the upcoming Phase 3 trial results to be very positive. Since we hold the first negotiation rights for the domestic market distribution, we plan to continue negotiations well.”
He added, “We also expect the listing of Humanigen on the U.S. stock market, led by JP Morgan, to gain momentum.”
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