InflaRx, Kiniksa anti-inflammatory mAbs yield trend toward lower COVID-19 mortality, plus Sinopharm reports antibody readout from vaccine trial
Plus FDA revokes EUA for Chembio serological test, Ortho receives BARDA award for antibody assay
After dexamethasone set a new bar for mortality reduction in COVID-19 patients this week, InflaRx and Kiniksa reported data from their anti-inflammatory mAbs showing trends toward a survival benefit.
InflaRx N.V. (NASDAQ:IFRX) announced on Wednesday interim data showing a trend toward lower mortality in severe COVID-19 pneumonia patients treated with IFX-1 plus best supportive care vs. best supportive care alone in the Phase II portion of an adaptive Phase II/III trial. However, the company lost $1.81 (25%) to $5.39 on the readout, which showed no difference in oxygenation, the primary endpoint, between the two cohorts.
InflaRx, which noted that the treatment cohort had more patients with ≥2 comorbidities associated with mortality than the control group, said it has begun the study’s Phase III portion evaluating 28-day mortality as the primary endpoint.
Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA) reported in a Lancet Rheumatology article published Tuesday that none of the 13 patients treated with mavrilimumab under an expanded access protocol had died as of day 28; none of the patients had been mechanically ventilated. By contrast, the mortality rate in 26 patients who received the standard of care (SOC) was 27% (p=0.086). Additionally, all patients given the anti-CSF2RA mAb had exhibited clinical improvement by day 28 vs. 65% of those given SOC (p=0.03).
The Bermuda-based company’s Phase II/III study will test mavrilimumab for severe COVID-19 pneumonia and hyperinflammation. Kiniksa gained $0.58 to $24.21 on Wednesday, when it announced the publication.
Meanwhile, Sinopharm revealed on Tuesday Phase I/II data showing that prime-boost administration of BBIBP-CorV on days 0 and 28 led to neutralizing antibodies in all participants. Additionally, 97.6% of volunteers who received the inactivated SARS-CoV-2 vaccine on days 0 and 21, or on days 0 and 14, generated antiviral antibodies. Sinopharm, which is seeking ex-China partners for Phase III testing, did not disclose titers.
At least three other COVID-19 vaccine developers -- Moderna Inc. (NASDAQ:MRNA), Sinovac Biotech Ltd. (NASDAQ:SVA) and CanSino Biologics Inc. (HKEX:6185) -- have reported clinical data. CanSino is the only one to have revealed neutralizing titers (see “Sinovac COVID-19 Vaccine Yields Neutralizing Antibodies”).
Citing concerns over accuracy, FDA has revoked Emergency Use Authorization (EUA) for DPP COVID-19 IgM/IgG System, a rapid serological test from Chembio Diagnostics Inc. (NASDAQ:CEMI) that detects IgG and IgM against SARS-CoV-2. The agency said Chembio’s data as well as an independent evaluation by the National Cancer Institute showed the assay generated more incorrect results than expected; and that the false result rate was higher than what was reflected in the authorized labeling.
Separately, Ortho Clinical Diagnostics Inc. has received a $678,000 award from Biomedical Advanced Research and Development Authority (BARDA) to continue developing its SARS-CoV-2 total and IgG antibody tests. Both tests have already been granted an EUA from FDA.
C5a - Complement 5a
CSF2RA - Granulocyte macrophage colony-stimulating factor receptor (CSF2RA) (GMR) (CD116) (GMCSFR)