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PTC Therapeutics Initiates Phase II/III Study for Coronavirus

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PTC Therapeutics, Inc. (PTCT - Free Report) announced that the initiation of a phase II/III study to investigate PTC299, a dihydroorotate dehydrogenase (DHODH) inhibitor, as a potential treatment for COVID-19.

The oral medication is a novel dual-mechanism agent designed to treat viral replication and uncontrolled inflammatory response.

The study will be conducted in two stages, which will be initiated in the United States, and the company plans to conduct research among patients in Spain, Brazil and Australia.

The first stage of the study will begin with 40 enrolled patients followed by a larger cohort of approximately 340 participants. The company’s primary objective is to evaluate the clinical efficacy of PTC299 compared with placebo, assessed by time to respiratory improvement in adult individuals hospitalized with COVID-19.

According to the company, the oral, small molecule tablet inhibits the dihydroorotate dehydrogenase (DHODH) cellular enzyme, which is used to produce the RNA building blocks for the production of SARS-CoV-2.

In addition, the investigational molecule has previously demonstrated potent inhibition of viral replication in SARS-CoV-2 cell-based assays. A number of RNA viruses require the same building blocks, which is why, in preclinical tests, PTC299 has shown broad-spectrum antiviral activity.

The shares of the company increased 4.8% year to date against the industry’s decline of 6%.

PTC299 is also being developed for oncological indications. Further, the candidateis currently being studied in a clinical trial in acute myeloid leukemia (AML) patients. In a PTC299 clinical study, results showed that the candidateinhibited DHODH, confirming the mechanism of action in patients.

Meanwhile, several marketed drugs like Sanofi/Regeneron’s IL-6 inhibitor,Kevzara; Roche’s (RHHBY - Free Report) IL-6 inhibitor, Actemra; Incyte/Novartis’ JAK1/JAK2 inhibitor, Jakafi; AstraZeneca’s (AZN - Free Report) BTK inhibitor, Calquence; and Amgen’s (AMGN - Free Report) PDE4 inhibitor, Otezla,  among others, are being evaluated to treat respiratory complications associated with COVID-19, which is the need of the hour.

 

Zacks Rank

PTC Therapeuticscurrently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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