Clinical Trials Suffer Casualties Due to Omicron
Mar 2, 2022 16:29:00 GMT
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Post by icemandios on Mar 2, 2022 16:29:00 GMT
March 2, 2022 10:40 AM EST R&DCoronavirus
Weaker Omicron variant is great news for the world, but bad news for Covid-related clinical trials
Zachary Brennan
Senior Editor
As the world cheers over the weaker (but still not quite mild) Omicron variant, with its reduced Covid-related hospitalizations and deaths when compared to the Delta variant, sponsors of clinical trials that depend on new Covid-19 cases to finish their work are being altered or halted because of Omicron.
SAB Therapeutics said early Wednesday that NIH has halted enrollment in its ACTIV-2 Phase III trial for its potential polyclonal antibody due to low Omicron-related hospitalization and death rates “that have made the current study design statistically unworkable.”
The federal government provided SAB with more than $100 million to develop its polyclonal antibody treatment. The company’s stock price fell by almost 50% on Wednesday.
The trial “was designed when previous COVID-19 variants resulted in high infection and hospitalization rates,” Eddie Sullivan, CEO of SAB Biotherapeutics, explained in a statement. “We look forward to analyzing data from the ACTIV-2 trial to help inform our future clinical initiatives when it becomes available.”
But this is the only potential Covid-19 treatment included in ACTIV-2 that has been halted due to Omicron. The arm is part of NIH’s randomized, double-blind, placebo-controlled trial that’s using a master protocol to evaluate eight different Covid-related outpatient treatments, some of which have already won an EUA (e.g., AstraZeneca’s Evusheld) and others for which enrollment had already ended.
An NIAID spokesperson told Endpoints News, “Low Omicron-related hospitalizations and death rates within the ACTIV-2 study led to the decision to halt enrollment in the arm testing SAB-185. No other arm of the ACTIV-2 trial has been stopped for that reason.”
The spokesperson also said NIH’s ACTIV-3 (for inpatient monoclonal antibodies or other treatments) and ACTIV-5 trial (known as the “Big Effect” trial for hospitalized Covid patients) “have either ended or enrollment has closed.”
Enrollment in ACTIV-2 previously ended for other potential outpatient mAbs from Brii Biosciences, which released Phase III results last October for its orally administered serine protease inhibitor developed by Sagent Pharmaceuticals, and other potential mAbs developed by Bristol Myers Squibb. BMS and Sagent did not immediately respond for comment on updates.
The only other drug that might still be actively enrolling participants was Synairgen’s inhalable beta interferon candidate. Neither the company nor NIH immediately offered comment.
Meanwhile, small Covid-19 vaccine developer Inovio announced Tuesday that it paused enrollment in its Phase III trial as it plans to seek FDA clearance to amend the primary endpoint of the trial from prevention of Covid-19 to prevention of severe disease.
“Omicron has thrown a curveball to all vaccine developers, with reduction in antibody responses from the original ancestral strain targeted vaccine,” Inovio CEO Joseph Kim told investors on an earnings call.
Weaker Omicron variant is great news for the world, but bad news for Covid-related clinical trials
Zachary Brennan
Senior Editor
As the world cheers over the weaker (but still not quite mild) Omicron variant, with its reduced Covid-related hospitalizations and deaths when compared to the Delta variant, sponsors of clinical trials that depend on new Covid-19 cases to finish their work are being altered or halted because of Omicron.
SAB Therapeutics said early Wednesday that NIH has halted enrollment in its ACTIV-2 Phase III trial for its potential polyclonal antibody due to low Omicron-related hospitalization and death rates “that have made the current study design statistically unworkable.”
The federal government provided SAB with more than $100 million to develop its polyclonal antibody treatment. The company’s stock price fell by almost 50% on Wednesday.
The trial “was designed when previous COVID-19 variants resulted in high infection and hospitalization rates,” Eddie Sullivan, CEO of SAB Biotherapeutics, explained in a statement. “We look forward to analyzing data from the ACTIV-2 trial to help inform our future clinical initiatives when it becomes available.”
But this is the only potential Covid-19 treatment included in ACTIV-2 that has been halted due to Omicron. The arm is part of NIH’s randomized, double-blind, placebo-controlled trial that’s using a master protocol to evaluate eight different Covid-related outpatient treatments, some of which have already won an EUA (e.g., AstraZeneca’s Evusheld) and others for which enrollment had already ended.
An NIAID spokesperson told Endpoints News, “Low Omicron-related hospitalizations and death rates within the ACTIV-2 study led to the decision to halt enrollment in the arm testing SAB-185. No other arm of the ACTIV-2 trial has been stopped for that reason.”
The spokesperson also said NIH’s ACTIV-3 (for inpatient monoclonal antibodies or other treatments) and ACTIV-5 trial (known as the “Big Effect” trial for hospitalized Covid patients) “have either ended or enrollment has closed.”
Enrollment in ACTIV-2 previously ended for other potential outpatient mAbs from Brii Biosciences, which released Phase III results last October for its orally administered serine protease inhibitor developed by Sagent Pharmaceuticals, and other potential mAbs developed by Bristol Myers Squibb. BMS and Sagent did not immediately respond for comment on updates.
The only other drug that might still be actively enrolling participants was Synairgen’s inhalable beta interferon candidate. Neither the company nor NIH immediately offered comment.
Meanwhile, small Covid-19 vaccine developer Inovio announced Tuesday that it paused enrollment in its Phase III trial as it plans to seek FDA clearance to amend the primary endpoint of the trial from prevention of Covid-19 to prevention of severe disease.
“Omicron has thrown a curveball to all vaccine developers, with reduction in antibody responses from the original ancestral strain targeted vaccine,” Inovio CEO Joseph Kim told investors on an earnings call.