Raleigh pharma får FDA-godkendelse til at udforske Covid-19-behandling

Udgivelsesdato:

Coming fresh off a $200 million raise, a drugmaker with a growing operation in the Triangle has received the go-ahead from the U.S. Food and Drug Administration to test one of its drugs as a treatment for Covid-19.

On Friday, Verona Pharma reported the FDA gave the company notice is can proceed with a investigational new drug (IND) trial of ensifentrine in patients with Covid-19.

The company plans to initiate a pilot clinical study on patients hospitalized with the virus at the University of Alabama at Birmingham.

Ensifentrine is the company’s lead drug candidate it has been developing has a maintenance treatment for COPD. Earlier data for the drug shows the investigational inhaled therapy acts as both a bronchodilator and an anti-inflammatory agent. In addition to COPD, the company believes it could be a treatment for cystic fibrosis patients.

According to Vernona, data on the drug from previous studies examining its effect on other respiratory diseases has “demonstrated ensifentrine improves lung function and reduces cellular markers of inflammation in the lungs.”

Because of that, the company says it believes the drug could improve oxygenation and lung function assisting recovery from the coronavirus.

The company, which reports a duel headquarters between London and Raleigh, most recently reported a $200 million raise in July, led by new investors including Boston-based RA Capital Management, Access Biotechnology, Perceptive Advisors, Acorn Bioventures, PBM Capital, Samsara BioCapital, Foresite Capital, Sphera, Fairmount and Soleus Capital.

With that new capital, the company told analysts and investors in its Friday morning earnings report it plans to initiate Phase 3 trials of ensifentrine for COPD later this year.

“We believe ensifentrine, with its novel mechanism of action, has the potential to improve oxygenation and lung function assisting recovery from Covid-19,” said CEO David Zaccardelli, who took the reins earlier this year.

According to financial data reported to the U.S. Securities and Exchange Commission on Friday, the company cash and equivalents of $22.4 million as of June 30 – before the raise which it says netted the company about $183 million following deductions.

In the six months ended the same date, the company reported an operating loss of $24.4 million.

According to Zaccardelli the pandemic has not affected operations in any drastic ways, and touted that despite its disruptions to the financial markets they were still able to obtain the $200 million raise.

“To date, the impact of Covid-19 on clinical development programs has been limited, but we continue to monitor the situation and have put in place mitigation strategies to reduce the risk of Covid-19 related delays,” he said in regards to their clinical trial plans.

Original artikelkilde: Triangle Business Journal