Tiziana Life Sci PLC - Completion of Foralumab Clinical Trial in Brazil
("Tiziana" or the "Company")
Tiziana announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in
- Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated
- The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses
- This trial is the first to evaluate nasally administered Foralumab to improve the immune system's fight against coronaviruses
The clinical study was completed in collaboration with scientific teams at the
The topline data from the trial is expected to be available in
Because COVID-19 enters through the nasal and respiratory passage, the proprietary nasal formulation and nasal delivery of Foralumab is an innovative approach to provide immediate relief to COVID-19 patients.
"Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients."
"We are delighted to receive positive feedback from patients treated in the clinical trial. Among the positive results patients reported, the most common was that the treatment resulted in the rapid improvement in smell sensation, which is frequently lost in COVID-19 patients."
"The observations made during the Clinical study did not show any adverse events."
The clinical study enrolled a total of 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the beginning of the study. This study had three cohorts: control (n=16), nasally administered Foralumab (n=12), and nasally administered Foralumab with 3 days of priming with orally administered 6 mg dexamethasone (n=11).
· The primary endpoint of this study was safety of the treatment, and secondary endpoints were to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression. The pharmacokinetics of nasally administered Foralumab will also be evaluated.
· Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.
"While we expect to get the topline data in
"We believe this approach could potentially provide benefits to patients already infected with COVID-19 and its newly identified variants. Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent COVID-19 infection, but it may not be useful for treatment of COVID-19 patients."
A further announcement will be made in due course.
The person who arranged for the release of this announcement on behalf of the Company was Dr
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.
For further enquiries:
+44 (0)20 7495 2379
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the