The company said it intends to initiate the clinical study in the first quarter of 2021.
FHI Clinical will run a trial of TZLS-501 delivered as an aerosol directly to the lungs using a hand-held nebulizer, said Tiziana.
STC Biologics is a boutique Good Manufacturing Practice (GMP) CRO that provides full chemistry, manufacturing and control (CMC) services.
Sciarra Labs will develop and test a hand-held nebulizer and be GMP manufacturing the anti-IL6R mAb solution to be used as clinical trial material for the study in COVID-19 patients.
ITR Laboratories Canada will conduct safety and toxicity studies with TZLS-501 delivered by a nebulizer directly into the lungs of cynomolgus monkeys.
TZLS-501 is a novel fully human mAb that binds to both the membrane-bound and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of cytokine release syndrome (CRS) and chronic inflammation in the lungs of patients with COVID-19 and acute respiratory illness such as Acute Respiratory Distress Syndrome (ARDS).
In a statement, Gabriele Cerrone, executive chairman of Tiziana, said: "We have moved quickly to accelerate our clinical development plan for TZLS-501 using our innovative delivery platform, which was developed by Howard Weiner, a world-renowned neurologist and Chairman of our Scientific Advisory Board."
Tiziana holds a worldwide exclusive license for TZLS-501 from Bristol Myers Squibb.
Dr Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, added: "Our proprietary inhalation technology for delivery of TZLS-501 to the lungs in COVID-19 patients is an attractive and most logical approach to deplete excessive levels of IL-6 to provide rapid relief. We are focusing on the development of oral, nasal and inhalation routes of mAb administration for immunotherapy."
"The common underlying concept in these alternative delivery approaches is to enable local or topical actions to maximize clinical action and minimize undesirable side effects commonly associated with intravenous and subcutaneous administration. Being a fully human anti-IL-6 receptor mAb, TZLS-501 is most suitable for long-term immunotherapies," he added.