TurnSole Announces Regulatory Authority Approval and Subsequent Initiation of a Phase Ib/II Trial to evaluate the efficacy and the safety of TS-020 in acute COVID-19 viral infection in Patients with Severe Infection with Risk of Progression
PÉCS, Hungary and BUDAPEST, Hungary, March 04, 2021 (GLOBE NEWSWIRE) -- TurnSole Biologics (TurnSole) today announced the start of a Phase I/II open-label study for Azacytidine, initiated with a lead-in dose escalation pharmacokinetic Phase I/b part in the 20–50 mg/m2 range to evaluate safety in Hospitalized COVID-19 Patients in Severe Infection with Risk of Progression as Add-on Therapy to Standard of Care, continued with a Randomized, Controlled, Open-Label Adaptive Phase II part to Determine Efficacy and Safety.
Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. Severe illness can occur in otherwise healthy individuals of any age, but it predominantly occurs in adults with advanced age or underlying medical comorbidities.
"Preclinical studies demonstrated that TS-020 interferes with SARS-CoV2 replication, triggers antiviral mechanisms of the infected cells and promotes anti-inflammatory immune cell differentiation. We believe that the complex action of TS-020, which is unique among the current medications, can provide a reasonable option for efficient treatment of COVID-19 patients at an advanced stage of infection," said Tibor Rauch, CSO of TurnSole.
TS-020 could be an effective agent in the treatment of COVID-19 infection through the following possible pathways:
- TS-020 can be incorporated into virus RNA and blocks mouse corona virus replication by 2 orders of magnitude in tissue cultures.
- TS-020 can also be incorporated into DNA and blocks catalytic activity of DNA methyltransferases leading to hypomethylation and activation of ZC3HAV1 gene triggering virus RNA degradation.
- RNA virus studies demonstrated that acute lung injury score was significantly decreased in mice after TS-020 treatment with survival rate of TS-020-treated animals significantly higher than in control groups.
- COVID-19 infection can cause venous and arterial thromboses. Virus induced epigenetic de novo DNA methylation in host cells can lead to inactivation of anticoagulant encoding genes. TS-020 can erase disease-associated de novo hypermethylation and restores expression of anticoagulant encoding genes. Additionally, TS-020 can be used to enhance the vascular repair.
- COVID-19 patients with acute respiratory distress syndrome due to viral infection are at risk of secondary complications like invasive aspergillosis. Reduced risk of fungal infection is a potential additional benefit of TS-020.
"We are extremely excited to be launching this phase I/II study in patients with severe infection with risk of progression in collaboration with the South-Pest Central Hospital in Budapest, Hungary (DPCK) led by Prof. István Vályi-Nagy, MD, PhD," Gábor Heltovics, CEO of TurnSole, notes. "Today, there is still a shortage of effective treatment options for Patients suffering from serious COVID-19 infections. The COVID-19 pandemic caused by one of many RNA viruses. These present a clear and continued risk of future outbreaks. Identifying readily available options to successfully treat the often-complex and severe symptoms of RNA viral infections remains to be major challenge."
Trial design. The Phase I/Stage 1 part is dose escalation to establish the tolerable maximal recommended Phase 2 dose (MRP2D). The Phase II partis open label, randomized controlled interventional adaptive-design study conducted with the MRP2D established in Phase I part as add on therapy to SOC in PhII/Stage 2 to enrol upto 40 patients, and as recommended being extended to PhII/Stage 3 to enrol not more than 96 additional patients, based on interim statistical recommendation. In the Phase II part, the patients will be randomized in a 3:2 ratio to receive standard of care plus Azacytidine or standard of care only, respectively. EudraCT identifier: 2021-000516-37. Upon completion of this trial, TurnSole will work with the FDA and EMA and potential pharmaceutical partners regarding next steps for TS-020 development.
TurnSole is a specialty pharmaceutical company dedicated to the development and commercialization of proprietary biological therapies and related clinical diagnostic solutions that deliver transformational improvements in clinical outcomes. TurnSole utilizes its breakthrough proprietary SEMY-TEC ® platform to develop personalized medicine for major unmet clinical needs within weeks of diagnosis. The Company’s asset portfolio contains compounds across a variety of indications and are protected by global composition of matter Intellectual Property.
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