Gufic Biosciences receives DCGI approval for Thymosin Alpha-1; Stock soars 1.5%

6 Apr 2022 , 10:48 AM

Gufic Biosciences Limited (Gufic) have 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 the 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, Immunocinα will prove to be a valuable addition to the treatment regime of 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 of Care Treatment (SOC) versus placebo with SOC. The clinical results are as summarized below:

• 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 efficacy of Immunocinαas a primary objective, in patients with moderate and severe COVID-19.
• Statistically significant (p value – 0.03) difference between two arms has been observed with respect to all cause mortality, where Immunocin α Arm has 11.1% Death rate compare to 38.5% in Placebo Arm, with absolute risk difference of 27.4%.
• 96% patients in 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.
• 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).
• 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.

At around 10:51 AM, Gufic BioSciences was trading at Rs262.90 apiece up by Rs3.95 or 1.53% on Sensex.