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PTC Therapeutics to Commence Phase II/III Coronavirus Study in US

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Zacks Equity Research
·3 min read
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PTC Therapeutics, Inc. PTCT announced that it has received authorization from the FDA to initiate a phase II/III study on its investigational oral DHODH inhibitor PTC299 for the potential treatment of coronavirus disease (COVID-19). The company plans to initiate an integrated study shortly in two stages in the United States.

The study will evaluate the safety and efficacy of PTC299 in the given patient population. The primary objective of the evaluation is to check the clinical efficacy of PTC299 as assessed by time to respiratory improvement in adults hospitalized with COVID-19 versus placebo.

Per the company, PTC299 has the potential to address two critical elements of COVID-19. For instance, it can reduce the high viral replication and also selectively attenuate the uncontrolled inflammatory response resulting from the SARS-CoV-2 infection.

Shares of PTC Therapeutics have increased 4.8% so far this year against the industry’s decrease of 5.4%.

Notably, PTC299 is a next-generation, oral selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH. The candidate is also being developed for the treatment of various oncological indications and is already evaluated in nine clinical studies in more than 300 individuals.

Another clinical study on PTC299 is also underway for acute myeloid leukemia (AML).

We remind investors that earlier this month, small biotech Immunic, Inc. IMUX too received allowance from the FDA to initiate a phase II study on its oral DHODH inhibitor IMU-838 for treating the deadly coronavirus disease. Top-line data from the same is expected later in 2020.

Notably, several other big companies are also working on developing new treatments/antibodies to combat the COVID-19 disease.

Pharma giant Eli Lilly LLY already has two antibody candidates in phase I studies for treating COVID-19.

Regeneron REGN is developing REGN-COV2, a novel investigational antibody "cocktail" treatment, designed to prevent and treat the SARS-CoV-2 virus. Clinical studies on the same began this month.

Zacks Rank

PTC Therapeutics currently 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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