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April 28, 2020 Bioscience Notebook

YNH tests asthma drug to treat COVID complication

IMAGE | Pixabay.com
By Natalie Missakian

A human trial being launched at Yale New Haven Hospital will test whether an existing asthma drug can treat a life-threatening lung complication of COVID-19.

Yale researchers are partnering with California-based MediciNova on the study of ibudilast, which has been approved for years in Japan and Korea, the university said in a news release.

An intense inflammatory response known as the “cytokine storm” is believed to lead to acute respiratory distress system (ARDS), the lung condition found in the most severe COVID-19 patients. 

“If you can modulate that, you can dial back the severity of the illness,”  Geoffrey Chupp, director of the Yale Center for Asthma and Airways Disease, said in the release. 

Ibudilast works by inhibiting MIF, a gene that regulates the immune response. Yale said the drug has shown promising results in animal studies. 

MediciNova had been studying the drug as a treatment for multiple sclerosis and neuroinflammation before shifting attention to COVID-19.

The trial will test the safety and efficacy of the drug to treat patients with COVID-19 pneumonia before they must be put on a ventilator. Yale said the researchers anticipate U.S. Food & Drug administration approval soon. 

Chupp, the principal investigator of the trial, is part of Yale’s Advanced Therapies Group, which was formed amid the pandemic to identify and advance possible coronavirus treatments. 

The group is also behind a clinical trial of another repurposed drug, sobetirome, to treat ARDS. 

* * *

A San Francisco company said it licensed from Yale the exclusive rights to a genomic blood test that can predict the progression of a lung-scarring disease known as idiopathic pulmonary fibrosis (IPF).

The deal, announced last Thursday, gives genomics diagnostic company Veracyte the rights to a 52-gene signature developed by Yale School of Medicine pulmonologist Naftali Kaminski, MD and others.

The gene signature can tell which patients may experience a rapid worsening of IPF, officials said.  

Veracyte said it will use the “first-of-its-kind” test on its nCounter FLEX Analysis System, the company’s diagnostic platform.

The test will be available as a complement to the company’s Envisia Genomic Classifier, which helps doctors differentiate IPF from other so-called interstitial lung diseases, eliminating the need for more invasive procedures. 

Veracyte CEO Bonnie Anderson said adding prognostic information will add value to the test as the company prepares to market it globally in 2021.

“The clinical implications of predicting outcomes in IPF are substantial,” Kaminski said in a statement. “Knowing which patients are likely to rapidly progress could allow more accurate and timely referral to appropriate treatments.”

* * *

Connecticut bioscience entrepreneur Jonathan Rothberg says his Guilford startup has finished an initial study of a rapid, at-home COVID-19 test at Yale with promising results. 

Rothberg tweeted on Friday that the company, Homodeus, is finalizing the data set for its COVID Detect test with the Yale team. 

“We are pleased to report that overall, our #SARSCoV2 isothermal assay with #RNA input was 93.3% concordant with the reference [standard] RT-qPCR test,” Rothberg tweeted. 

“We still need to do a LOT of #validation on the #sensitivity (correctly identify those with the #COVID19) & specificity (correctly identify those without),” he added.

COVID Detect is a molecular test that is based on the genetic code of the virus. Unlike antibody testing, it would show positive results as soon as a person is infected and patients would test negative once they are no longer infectious, Rothberg has said.  

New Haven BIZ was first to report Rothberg’s work on the test in March. He has said that it would be as fast and easy to use as a home pregnancy test.

* * *

New Haven biotech Arvinas Inc. posted higher losses during the first quarter of 2020, compared to a year ago, but still beat Wall Street expectations as it continued to move its drugs for advanced prostate and breast cancer toward regulatory approval. 

The company founded by Yale scientist Craig Crews also said it ended the quarter with enough cash to fund operations through 2022.

For the first three months of the year, Arvinas posted an adjusted net loss of $21.7 million, or 56 cents a share, compared to $14.2 million (46 cents a share) for the first quarter of 2019.  

The higher loss comes despite a $2.2 million boost in revenue compared to the year-ago period, mostly from payments stemming from collaboration agreements with Bayer and Pfizer, the company said. Arvinas said it brought in $6.2 million for the quarter, although it does not yet have any revenue-producing products. 

Arvinas said its R&D expenses rose to $21.7 million for the quarter, up from $14.2 million a year ago. It attributed the jump to increased investments in its prostate and breast cancer drugs and other research. 

General and administrative expenses were $7.9 million, compared to $5.6 million during the first quarter of 2019. Arvinas attributed the increase to higher personnel and facility-related costs.

Arvinas’ net loss beat analysts’ projected 59-cents-per-share shortfall, while revenue surpassed expectations by more than 20 percent, according to Zacks Investment Research.

The company ended the quarter with $262.8 million in cash, compared to $280.9 million at the end of 2019.

Arvinas' stock was trading at $53.58 just after noon Tuesday, down from Monday's close of $54.50.

The seven-year-old company is developing a new class of drugs known as protein degraders, which induce the body to purge itself of disease-causing proteins. 

* * *

Biohaven Pharmaceuticals on Monday announced a second distribution deal to market its newly approved migraine drug Nurtec ODT abroad.

The New Haven drugmaker said Genpharm Services, based in Dubai, will distribute Nurtec in the Middle East and Gulf countries. Financial terms were not disclosed.

The deal follows Biohaven’s April 16 announcement of an agreement with Medison Pharma to distribute the drug in Israel.

“Our agreement with Genpharm is further evidence of our commitment to make Nurtec ODT as widely available as possible to patients suffering from migraine, and as quickly as possible, regardless of location,” Donnie McGrath, Biohaven’s head of corporate strategy and business development, said in a statement.

Biohaven’s stock rose nearly 5 percent Monday morning on the news. It opened at $48.75 on Tuesday.

Nurtec ODT is a CGRP-antagonist that dissolves in the mouth without water. The FDA approved the drug for the acute treatment of migraine in February.

Contact Natalie Missakian at news@newhavenbiz.com.

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