India, May 9: Gufic Biosciences Limited (Gufic) has received DCGI approval for Thymosin Alpha-1 (Immunocinα A Brand of Gufic for the said drug) as an add-on therapy for the treatment of moderate to severe COVID-19 patients requiring ventilator support (NIV as well as Mechanical Ventilation). The pathophysiology and clinical symptoms for Sepsis is the same as for Covid-19. ThymosinAlpha 1, an Immuno-modulator drug, significantly reduces the risk of death, ventilation days and ICU days, also decreasing hospitalization days as per the various international studies conducted.
Sepsis, a severe and life-threatening complication of an infection, is growing tremendously in India. Today, around one out of two patients admitted in ICU are affected with sepsis across India. The mortality rate/death rate is exceptionally high in severe sepsis patients. Sepsis occurred when chemicals released in the bloodstream to fight an infection trigger inflammation throughout the body. This can cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even death. Symptoms include fever, difficulty breathing, low blood pressure, and fast heart rate.
Dr Yatin Mehta, Chairman, Institute of Critical Care & Anaesthesiology, Medanta -The Medicity Hospital, Gurugram, said, “Sepsis is a syndromic response to infection and is frequently a final common pathway to death from many infectious diseases worldwide. A recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths”.
Dr Mehta added, “A study on Indian patients demonstrated that 56.4% of patients admitted in the intensive care unit were suffering from sepsis. In these patients, the most common microorganisms were bacterial (77.9%) followed by fungal (14.1%) infections.”
Dr Yatin Mehta further said, “Thymosin Alpha 1 molecule is an immunomodulator and an add-on therapy which acts on T-Lymphocytes Cells. This therapy has come as a boon for the treatment of sepsis patients. The therapy helps bring down the mortality rate, the ventilator days, and ICU stays, which helps the patients save on cost, too, as the length of stay in hospital is eventually reduced. Central Drugs Standard Control Organisation has already approved thymosin Alpha 1 molecule to treat Covid-19. The pathophysiology and treatment for Covid-19 and Sepsis are almost the same.”
Dr Debesh Das, COO (Formulation Business) Gufic Biosciences, said, “The medical fraternity urgently needs many more tools to fight against the menace of Sepsis, which is a leading cause of mortality and affects the social wellbeing and healthcare system all around the world. Looking forward to the convincing results of that we got in for thymosin, as an add-on therapy for the treatment of moderate to severe COVID-19 patients, we are optimistic that Immunocin α can become an important drug in the global efforts to fight sepsis and will add to Gufic’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Gufic has been relentlessly committed to saving and improving lives. We will continue to work with regulatory agencies on our applications and do everything we can to bring novel molecules to patients as quickly as possible.”