Today’s Daily Dose brings you news about the revocation of approval for Chembio’s antibody test for COVID-19; resumption of Eloxx’s cystic fibrosis trial after a brief pause due to the pandemic; encouraging results of Humanigen’s Lenzilumab in COVID-19 patients; InflaRx’s COVID-19 trial results and PTC Therapeutics repurposing its investigational cancer drug to treat COVID-19.
1. Approval For Chembio’s Antibody Test Revoked On Higher Than Expected False Results
Shares of Chembio Diagnostic System Inc. (CEMI) took a beating on Wednesday, following revocation of the emergency use authorization of the Company’s DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test.
The unfavorable action was based on performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to COVID-19.
The Chembio DPP COVID-19 IgM/IgG System was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency. Now, data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI have shown that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device.
CEMI closed Wednesday’s trading at $3.89, down 60.83%.
2. Eloxx To Resume Cystic Fibrosis Trial After Brief Pause Due To Pandemic
Eloxx Pharmaceuticals Inc. (ELOX) has resumed enrollment in its phase II clinical trial for ELX-02 in cystic fibrosis in Israel and Europe, after being temporarily paused in response to the COVID-19 pandemic in late March. However, the U.S. trial remains temporarily paused due to the pandemic.
Gregory Williams, Chief Executive Officer of Eloxx, said, “We remain committed to completing enrollment in our Phase 2 proof of concept clinical trial program and reporting top-line data as soon as feasible. We will provide further updates as they become available.”
ELOX closed Wednesday’s trading at $3.05, down 2.24%. In after-hours, the stock gained 41.31% and was at $4.31.
3. Humanigen’s Lenzilumab Shows Promising Results In COVID-19 Trial
An analysis of the first clinical use of Humanigen Inc.’s (HGEN) investigational drug Lenzilumab in twelve COVID-19 patients has shown some encouraging results.
Lenzilumab is designed to prevent and/or treat cytokine storm that precedes severe lung dysfunction and ARDS (acute respiratory distress syndrome) in serious cases of SARS-CoV-2 infection.
Patients treated with Lenzilumab showed rapid clinical improvement with a median time to improvement of five days and a median time to recovery of five days. In comparison, patients treated with Gilead’s Remdesivir demonstrated a median time to the improvement of 10 to 11 days and a median time to recovery of 10 to 11 days.
Remdesivir was granted emergency use authorization based on time to recovery of 11 days in the Adaptive COVID-19 Treatment Trial (ACTT-1).
A potential registrational phase III study of Lenzilumab in COVID-19 patients is currently enrolling.
Humanigen, formerly known as KaloBios, was previously led by the controversial ex-drug executive Martin Shkreli. In December 2015, he was ousted as CEO of KaloBios. Nearly after 2 years, i.e., in August 2017, KaloBios changed its name to Humanigen.
HGEN closed Wednesday’s trading at $4.15, down 17.33%.
4. InflaRx’s IFX-1 Fails To Improve Oxygenation Index But Improves Mortality In Covid-19 Study
Shares of InflaRx (IFRX) plunged over 25 percent as its phase II part of phase II/III trial of IFX-1 in patients with severe COVID-19 pneumonia failed to meet the primary endpoint of the relative change from baseline to day 5 in oxygenation index.
However, IFX-1 treatment was associated with lower 28-day all-cause mortality when compared to the best supportive care group, along with trends in disease improvement, as evidenced by fewer patients experiencing renal impairment assessed by estimated glomerular filtration rates, more patients showing reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations, according to the Company.
Additionally, in IFX-1-treated patients, pulmonary embolisms reported as serious adverse events were lower compared to the best supportive care arm.
The phase II part of the trial of IFX-1 involved a total of 30 patients, with 15 patients treated in each arm – IFX-1 plus best supportive care or best supportive care alone.
InflaRx will be continuing the phase III part of the study using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.
IFRX closed Wednesday’s trading at $5.39, down 25.07%.
5. PTC Therapeutics Repurposes Cancer Drug To Treat COVID-19
PTC Therapeutics Inc. (PTCT) is evaluating its investigational cancer drug PTC299 in phase II/III trial as a potential treatment for COVID-19. The study is expected to commence in the U.S. in the coming days with additional sites planned globally.
According to the Company, PTC299 is an oral investigational drug with a novel dual mechanism of action that has the potential to address the two critical elements of COVID-19 – the high viral replication and the uncontrolled inflammatory response that ensues after infection.
A phase Ib study of PTC299 in participants with relapsed/refractory acute myeloid leukemia is also underway.
PTCT closed Wednesday’s trading at $50.34, down 0.50%.
6. Stocks That Moved On No News
American Shared Hospital Services (AMS) closed Wednesday’s trading at $3.10, up 43.85%.
Millendo Therapeutics Inc. (MLND) closed Wednesday’s trading at $3.28, up 37.82%.
Forward Pharma A/S (FWP) closed Wednesday’s trading at $7.42, up 19.87%.
Celsion Corporation (CLSN) closed Wednesday’s trading at $4.25, down 12.91%.
Immuron Limited (IMRN) closed Wednesday’s trading at $8.22, down 12.55%.
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