Gufic receives DCGI nod for Thymosin Alpha - 1

Gufic Biosciences Limited today announced that it has received DCGI approval for Thymosin Alpha-1 (Immunocin α - 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). Immunocin α, an Immuno-modulator drug, significantly reduced the risk of death in Phase 3 Clinical trial in adult patients with moderate-to-severe COVID-19.

The medical armamentarium urgently needs many more tools to fight the COVID-19 pandemic, which is a leading cause of mortality and a strain on the social wellbeing and healthcare system all around the world. "Looking at the convincing results, we are optimistic that Immunocin α can become an important drug amongst the global efforts to fight the COVID-19 pandemic 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," said Dr. Adarsh Shetty, General Manager - Medical Affairs of Gufic.

As the virus is still circulating widely and the therapeutic interventions available to people with COVID-19 are limited, Immunocin α will prove to be a valuable addition to the treatment regime for COVID-19.

More about ImmunocinαPhase 3 Study

Immunocin α Phase 3 Study was a Multi-centric, Randomized, Placebo-Controlled, Double-Blind Study in hospitalized adult patients with laboratory-confirmed moderate-to-severe COVID-19. The primary objective of the study was to assess and compare the efficacy of Thymosin α-1 (Tα1) in combination with Standard Care Treatment (SOC) versus placebo with SOC. The clinical results are summarized below:

1. All the first 105 patients who had taken at least one dose of study medication were taken into analysis. This study was designed to explore the efficacy of Immunocin α as a primary objective, in patients with moderate and severe COVID-19.

A statistically significant (p value - 0.03) difference between the two arms has been observed with respect to all-cause mortality, where Immunocin α Arm has an 11.1% Death rate compared to 38.5% in Placebo Arm, with an absolute risk difference of 27.4%.

3. 96% of patients in the study arm have shown improvement after 7 days of treatment with Immunocin α along with SOC in WHO's 8-point Ordinal score Vs 57% in placebo arm group.

4. WHO Ordinal scale Comparison of the mean change from baseline on both arms shown to be statistically significant for moderate and severe COVID-19 (p-value Moderate- 0.002, Severe-0.001).

5. Immunocin α treatment compared to placebo, has shown 2 days less hospitalization and 4 less ventilator days in moderate and severe COVID-19 patients respectively.

About Thymosin α-1

Thymosin α 1 (Immunocin α) is an endogenous polypeptide hormone secreted by thymic epithelial cells. As an immunomodulatory therapy, Thymosin α 1 has been investigated in many diseases involving immune dysfunction (such as sepsis, cystic fibrosis, and hepatitis viral infection) and is associated with an improved patient outcome.

Thymosin α 1 increases T cell numbers by promoting T cell development and proliferation, enhancing their function and preventing & corrects lymphopaenia.