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April 14, 2020 Bioscience Notebook

Biohaven gets FDA green light for COVID drug trial

IMAGE | Pixabay.com
By Natalie Missakian

Biohaven Pharmaceuticals is about to launch a clinical trial to see if one of its experimental migraine drugs can stop a potentially fatal lung complication in some patients with COVID-19.

The U.S. Food & Drug Administration green-lighted the trial on April 8, and Biohaven said it will begin “within weeks.”

The drug, vazegepant, is Biohaven’s follow-up to its migraine drug Nurtec ODT, which won FDA approval in February. Like Nurtec, vazegepant is a CGRP (calcitonin gene-related peptide) receptor antagonist, but is administered as a nasal spray instead of a tablet.

Biohaven is already testing the drug for the treatment of migraine attacks. It now wants to find out if the drug can also block the hyper-immune response believed to be responsible for the most severe and deadly cases of COVID-19.

"There is a solid scientific rationale supporting testing of small-molecule CGRP antagonists as a way to mitigate the neuro-immune consequences of respiratory viral infections like COVID-19,” Donnie McGrath, MD, Biohaven’s chief of corporate strategy, said in a statement. 

Biohaven believes its drug “may potentially blunt the severe inflammatory response [in the lungs] at the alveolar level, delaying or reversing the path towards oxygen desaturation, ARDS (acute respiratory distress syndrome), requirement for supplemental oxygenation, artificial ventilation or death.”

Biohaven said it will collaborate with Thomas Jefferson University and other academic medical institutions on the study.

The trial will examine the safety and efficacy of the drug for COVID-19 infected patients who require supplemental oxygen, versus a placebo.  

“There is an urgent need to identify treatments that can mitigate the inflammatory process in these patients and help stabilize our response to the pandemic,” said Jesse Roman, MD, head of the Jane & Leonard Korman Respiratory Institute at Thomas Jefferson University and one of the study’s principal investigators. 

* * *

Biohaven is not the only local company trying to repurpose one of its drug candidates for treating the deadly COVID lung complication. 

Branford’s Thetis Pharmaceuticals is looking into whether TP317, its experimental drug for inflammatory bowel disease, could also be helpful in treating ARDS. The treatment delivers a natural bioactive lipid that regulates the inflammatory response. 

CEO Gary Mathias outlined the company’s plan during a virtual panel discussion last week sponsored by BioCT. He said recent research has shown 42 percent of patients hospitalized with COVID-19 develop ARDS — and half of those patients die. 

The drug has already undergone preclinical studies for IBD. Mathias said the company is hoping to begin human testing during the third quarter of this year.

* * *

Two major hospitals conducting clinical trials for Arvinas’ experimental prostate cancer drug have stopped enrolling new patients due to the coronavirus pandemic.

But the New Haven biotech said in a business update Monday that it doesn’t expect to push back the release of data for the trial, which is scheduled to be presented at the American Society of Clinical Oncology annual meeting May 29 to June 2. 

Arvinas said it is working with the two hospitals, Yale New Haven and Massachusetts General in Boston, to “understand the timing of enrollment restarts while maintaining the safety of patients as our top priority.” 

Patients already enrolled will continue to receive doses on schedule, Arvinas said. 

Another study site, the University of California/Los Angeles, temporarily paused enrollment in Arvinas’ breast cancer trial for another drug, ARV-471, but that delay has already been lifted, Arvinas said. Data for that trial is on schedule to be released later this year.

“Arvinas is working with all sites to develop contingency plans that maintain the highest standards for patient care and study data integrity while affording flexibility in study visits during the COVID-19 pandemic, consistent with recent FDA guidance,” the company said in its update.

The contingency plans include the potential use of telemedicine and remote monitoring plans and allowing certain assessments to be completed virtually, Arvinas said.

Arvinas’ compounds are part of a new class of cancer drugs known as protein degraders, which induce the body’s own protein-removal system to eliminate proteins that cause disease. 

Arvinas has said its prostate cancer drug is the first of its kind to be tested in humans. 

 

Correction: An earlier version of this story had an incorrect date for the planned release of data for Arvinas' prostate cancer trial. 

Contact Natalie Missakian at news@newhavenbiz.com.

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