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PTC Therapeutics Announces the Initiation of a Phase 2/3 Clinical Trial to Evaluate PTC299 for the Treatment of COVID-19
- Oral treatment with novel dual-mechanism of action has the potential to address the two critical elements of COVID-19; viral replication and uncontrolled
About this update from Ptc Therapeutics, Inc.
[{"type":"text","content":"- Oral treatment with novel dual-mechanism of action has the potential to address the two critical elements of COVID-19; viral replication and uncontrolled inflammatory response -\n - Randomized, double-blind, placebo-controlled, multi-national Phase 2/3 clinical study with two stages to initiate in the U.S. in coming days -\n - CTA submitted in Spain with additional filings planned in Europe, Brazil and Australia -\n - Conference call scheduled for 8:30 am ET -\n\n\nSOUTH PLAINFIELD, N.J., June 17, 2020 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the U.S. Food and Drug Administration has authorized the initiation of a Phase 2/3 trial to investigate PTC299, a dihydroorotate dehydrogenase (DHODH) inhibitor, as a potential treatment for COVID-19. PTC299 is an oral investigational drug with a novel dual-mechanism of action that has the potential to address the two critical elements of COVID-19: 1) the high viral replication and 2) the uncontrolled inflammatory response that ensues after infection. PTC will initiate an integrated Phase 2/3 study in the U.S. in the coming days with additional sites planned globally. \n\"We are excited about the potential of PTC299 to be part of the solution to this unprecedented global public health crisis and have made it a high priority within our organization,\" said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. \"The fact that PTC299 inhibits DHODH uniquely addresses the two key issues of COVID-19, namely reducing the high viral replication and also selectively attenuating the immune response caused by the uncontrolled cytokine storm resulting from the SARS-CoV-2 infection.\"\nPTC299 is an oral, small molecule tablet that inhibits the cellular enzyme DHODH which is used to produce the RNA building blocks for the production of SARS-CoV-2. PTC299 has demonstrated potent inhibition of viral replication in SARS-CoV-2 cell based assays, which has led to PTC moving rapidly into the clinic. A number of RNA viruses require the same building blocks, which explains why in preclinical tests PTC299 has shown broad-spectrum antiviral activity. \n\"Infection with SARS-CoV-2 has caused COVID-19 in millions of people around the world and the death of hundreds of thousands. In the year ahead, SARS-CoV-2 could infect and kill even greater numbers of people....