UK biotech Tiziana Life Sciences (Nasdaq: TLSA) is collaborating with Parexel Biotech, a division of global clinical research organization (CRO), Parexel International (IRL), to conduct a global Phase Ib/II trial with enteric-coated capsules of formulated foralumab, the only fully human anti-CD3 monoclonal antibody (MAb) - as a therapy for patients with moderate to severe Crohn’s disease (CD).
This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the USA and Europe, said Tiziana, whose shares were up 6.7% at 103.00 pence in late-morning trading today.
Tiziana and antibody-based drug manufacturer Novimmune entered into an agreement in 2014 whereby Novimmune granted Tiziana an exclusive license for the clinical development and commercialization of foralumab, in a deal valued at around $2 million.
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