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Tychan to begin Ph 3 trial for mAb TY027 against COVID-19

14 December 2020 | News

The Phase 3 clinical trial is the final phase of trials for TY027 and will involve 1,305 volunteer COVID-19-positive patients from partner hospitals.

Source credit: Shutterstock

Source credit: Shutterstock

In June 2020, Tychan began its Phase 1 clinical safety trials in humans to evaluate TY027, a monoclonal antibody (mAb) that specifically targets SARS-CoV-2, the virus that causes COVID-19. In October 2020, approval from Health Sciences Authority of Singapore (HSA) was obtained for the Phase 3 clinical trial to begin as part of the progression of the antibody development. The trial will start in Singapore at partner hospitals Singapore General Hospital and National University Hospital, with Changi General Hospital and Sengkang General Hospital as referral sites.

TY027 is being explored for treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as potentially providing temporary protection against infection from SARS-CoV-2.

Studies supporting the new drug application, including chemistry, manufacturing, and control, and the Phase 1 trials were completed thoroughly and safely.

The Phase 3 clinical trial is the final phase of trials for TY027 and will involve 1,305 volunteer COVID-19-positive patients from partner hospitals. If the antibody is proven efficacious in this trial, it will be submitted for review by HSA and other regulatory agencies as a new drug.

As there is low incidence of COVID-19 in Singapore, the Phase 3 clinical trial for TY027 will also take place in partner hospitals overseas, such as Sheba Medical Centre in Israel. With the support of Singapore’s Whole-of-Government collaboration in developing a COVID-19 antibody, Tychan is also exploring collaborations with medical facilities in other countries to conduct the trial.

Tychan developed TY027 in partnership with the Ministry of Defence, Ministry of Health, the Economic Development Board and other government agencies as part of a Whole-of-Government collaborative effort.

Professor Sasisekharan said, “We hope that the TY027 will soon be a valuable option for patients impacted by this devastating disease.”

This accelerated timeline is made possible through the use of Tychan’s proprietary technology and Rapid Response platform developed by Professor Sasisekharan and Professor Ooi.

“We are hopeful that TY027 will pass the Phase 3 clinical trial and be deployed as soon as possible to mitigate the adverse impact brought by COVID-19,” said Professor Ooi.

“We take comfort that our development process for the TY027 is fast and can indeed be a Rapid Response platform against infectious diseases in the future,” added Teo Ming Kian, Chairman of the Board, Tychan.

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