Mankind Pharma and Daewoong Pharmaceutical Announce Initiation of Phase 1 Clinical Trial on a ‘Novel’ Formulation of Niclosamide (DWRX2003) for COVID-19 Treatment

Mankind Pharma and Daewoong Pharmaceutical Announce Initiation of Phase 1 Clinical Trial on a ‘Novel’ Formulation of Niclosamide (DWRX2003) for COVID-19 Treatment
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Mumbai: Daewoong Pharmaceutical Co., Ltd., South Korea (through its subsidiary, Daewoong Pharmaceutical India Pvt. Ltd.) and Mankind Pharma, fastest growing Indian Pharmaceutical Company, have collaborated for conducting Phase I clinical trial of a long acting intramuscular formulation of Niclosamide. The trial is designed towards addressing the need for a science-based investigation on this new formulation “Niclosamide (DWRX2003)” based on encouraging preclinical evidence for the treatment of COVID-19.

Niclosamide (DWRX2003) is already in clinical use as an anthelmintic; however, the current formulation is expected to be a longer acting variant for this alternate clinical indication. It is also expected to circumvent the downside of oral administration.

In vitro, Niclosamide (DWRX2003) was found to be 40, 26 & 15 times more potent than Remdesivir, Chloroquine & Ciclesonide respectively for its anti-viral action against SARS-CoV-2 virus. Also, the injectable intramuscular (IM) formulation of Niclosamide successfully removed the virus from lungs in animal tests, thereby countering viral infection, besides preventing cytokine storm which is the major cause of mortality in moderate to severe cases of COVID-19.

Through intensive motivated research, Daewoong researchers worked on quick development of the formulation to have reached the stage of “First-in-Human” evaluation, successful completion of which would immensely facilitate COVID-19 disease treatment.

Mr. Arjun Juneja, COO, Mankind Pharma Ltd. commented, “We are continuously evaluating various target products for the treatment of Covid-19 in support to national response to COVID-19 pandemic. In continuation to Mankind Pharma vision to service society by bringing quality and affordable medicine. We are excited to collaborate with Daewoong Pharmaceutical Co., Ltd. to bring Novel formulation of Niclosamide (DWRX2003) for the treatment of COVID-19 patients in India. We believe that the product would provide for a safe and effective alternative to patients suffering from this disease.”

We are already working on other unrelated COVID-19 focussed programs, in tandem with community and society as part of our Corporate Social Responsibility initiatives.

Sengho Jeon, CEO of Daewoong Pharmaceutical commented, “Through development of candidates for COVID-19 treatments such as Nicosamide, which Daewoong Pharmaceutical is currently developing, we expect to provide innovative treatment option for patients suffering from COVID-19. I believe Mankind Pharma is one of the best partner to accelerate the clinical development and supply of DWRX2003 for India."