In an outlook statement accompanying its results for the six months to June 30, the AIM-listed biotech said it is set to sponsor a Phase II nasal foralumab trial in secondary progressive Multiple Sclerosis (MS) patients treated with Ocrevus, a drug used for relapsing remitting and for primary progressive MS, with a response from the US Food and Drug Administration (FDA) expected by mid October and the trial expected to begin in the fourth quarter of 2020.
The firm also said it is working with investigators in Brazil who will conduct a clinical trial in coronavirus (COVID-19) patients with nasally-administered Foralumab to evaluate its ability to suppress inflammation in the nasal and respiratory tract, the primary sites of Covid-19 induced inflammation.
Tiziana also said upon successful completion of a Phase 1 trial it is in discussions with contract research organisations (CROs) to design and conduct a Phase II clinical trial in moderate to severe Crohn's disease patients with orally administered foralumab.
Additionally, the group said it has expedited its clinical development plan for its anti-Interleukin-6-Receptor (TZLS-501), a fully human monoclonal antibody, for the treatment of COVID-19 patients, and intends to initiate a clinical study of the receptor in the first quarter of 2021.
“Looking ahead, Tiziana is confident that it is well positioned to advance these programs to their next respective value inflection points”, executive chairman Gabriele Cerrone said in a statement.
In the figures for the half year, Tiziana reported an operating loss of £3.9mln compared to a £3.6mln loss in the previous year, while the company ended the period with £7.2mln in cash.
Highlights in the period included the filing of three US patent applications, while three US patents were issued and another two filed post-period.
Tiziana shares were 2.2% lower at 131p in early deals on Wednesday.