PharmaEssentia Corp (藥華醫藥) plans to apply with the US Food and Drug Administration (FDA) to run clinical tests of its new drug Besremi for COVID-19, the firm said yesterday.
The interferon drug, which modulates immune response by interning with viral proliferation, was designed to treat polycythemia vera, a rare blood disease, and has been marketed in Europe since last year, PharmaEssentia said.
However, given that there is no specific treatment for COVID-19 and some studies have found that alpha-type interferons combined with other antiviral drugs worked against Middle East respiratory syndrome in animal tests, the firm aims to test whether its drug can treat COVID-19, PharmaEssentia chief executive officer Lin Ko-chung (林國鐘) told a news conference in Taipei.
Moreover, studies have shown that alpha-type interferons could reduce the possibility of infection of the novel coronavirus, Lin said.
The company has prepared a plan to use Besremi to treat people infected with COVID-19, including details of target patients, dosage and optimal timing of injection to apply for the FDA’s Coronavirus Treatment Acceleration Program, he said.
The company declined to reveal when it would submit its applications, only saying that it would discuss its plan with the agency first.
As the drug would normalize the immune response, it is expected to work best on mild cases and help prevent severe pneumonia, the firm said.
Immune response has been a key issue in combating the pandemic, with some studies saying that patients had severe symptoms as a result of a “cytokine storm,” an overreaction of the body’s immune system.
However, the company’s drug would not have such concerns, as it normalizes immune response, Lin said.
PharmaEssentia’s marketing partner in the EU has told the firm to prepare more Besremi for people in the bloc with myeloproliferative neoplasm, as the UK’s National Health Service has warned that people with blood diseases who take ruxolitinib might develop weakened immunity, he said.
PharmaEssentia said it expects to gain approval this month.
The company in July last year applied to local regulators to market Besremi as treatment for polycythemia vera.
It submitted an application last month with the US regulator hoping to gain marketing approval for the drug as a polycythemia vera treatment by the end of this year.
PharmaEssentia posted a net loss of NT$842 million (US$27.95 million) for last year due to high research and development costs, an improvement from a net loss of NT$1.03 billion in 2018.
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