Protection has been granted around the “methods and use” of anti-IL 6 and IL-6 receptor monoclonal antibodies for both protective (prophylactic) and therapeutic use.
The grant of this additional patent on TZLS-501 is of “particular significance” for the potential treatment of COVID-19 and other pulmonary diseases such as acute respiratory distress syndrome, the company said.
In the case of COVID, the treatment offers the promise of providing immediate respite if the drug is inhaled directly using a handheld nebuliser.
“The granting of this patent along with our previously filed patent application on inhalation delivery of anti-IL-6 mAbs strengthens our intellectual property for the treatment of lung diseases,” Tiziana chief executive, Dr Kunwar Shailubhai said in a statement.
He added that the company is “expediting” the clinical development of TZLS-501. So, work is ongoing to scale-up manufacturing, develop the inhalation delivery system and to safety test it.
Completion of these studies will enable Tiziana to file an investigational new drug application and initiate a clinical trial in COVID-19 patients by the first quarter of next year, said Shailubhai.
“Subsequently, we plan to use TZLS-501 with the same inhalation delivery technology for the treatment of patients with acute respiratory distress syndrome,” he added.