Tiziana Life PLC (NASDAQ:TLSA; LON:TILS) is preparing to embark on a clinical study of what would be the first orally-taken home treatment for Crohn’s Disease (CD) using a monoclonal antibody (mAb).
It is collaborating with Parexel Biotech, a subsidiary of the contract research giant Parexel, to conduct the phase Ib/II trial of a coated pill containing Foralumab, a fully-human mAb.
In doing so, researchers from Europe and the US will assess for safety, tolerability and clinical activity of escalating doses of the treatment.
Dr Howard Weiner, head of Tiziana’s scientific advisory board, called the development of a CD medication taken by mouth as a “potentially ground-breaking” alternative to immunosuppressives administered intravenously.
Severe toxicities and poor patient compliance can limit the long-term use of the latter, Tiziana pointed out. Ease of use of a pill taken at home should increase compliance by eliminating the need for infusions in a clinic or hospital, it said.
Additionally, it described using Foralumab orally as “very attractive approach” as it may provide local action to treat gut inflammation in patients with CD.
In kicking off clinical research in CD, Tiziana is entering a market that will be worth an annual US$4.7bn by 2025, but where the specific causes of the condition are still not fully understood.
However, the severe gut inflammation prevalent in people with CD is broadly known to be caused by an overactive immune system attacking the intestines, colon and other organs.
This is why immunosuppressive agents and anti-tumour necrosis factor immunotherapies represent the main treatment options.
“We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field,” said Weiner in a statement.
Recently, Tiziana announced positive results from a phase I study showing that oral treatment with Foralumab was well-tolerated in healthy volunteers, with no drug-related safety issues even at the highest dose.
The company’s research team also successfully demonstrated that nasally-administered Foralumab was not only well-tolerated but also produced desirable immunological responses.
Both oral and nasal administration are designed to stimulate the mucosal immune system to induce disease-modifying benefits.
“We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies,” said the company’s chief executive, Dr Kunwar Shailubhai.