Benzinga | Nov 11, 2020 05:43AM EST

Tiziana Life Sciences Announced Collaboration With Parexel Biotech to Conduct Phase 1b/2 Clinical Trial in Patients With Crohn's Disease

Tiziana Life Sciences plc (NASDAQ:TLSA) today announced it is collaborating with Parexel Biotech ("Parexel"), a division of a leading global clinical research organization ("CRO"), Parexel International (IRL) Limited, to conduct a global Phase 1b/2 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 U.S. and Europe.

Dr. Howard L. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented:

"We understand that this will be the first-ever study with take-home' capsules of any mAb for immunotherapies for human diseases. 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."

"Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated, but also produced desirable immunological responses. Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits."

The CD therapeutic market size will be worth $4.7 billion by 2025, according to Grand View Research1. CD is a chronic disorder of the immune system that causes inflammation throughout the digestive tract. Although the specific causes of CD are still not clearly understood, severe gut inflammation caused by an overactive immune system attacking the intestines, colon and other organs appears to contribute to disease pathology. Thus, immunosuppressive agents and anti-TNF (Tumour Necrosis Factor) immunotherapies represent the main therapeutic options to maintain remission in CD. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Oral administration with take-home capsules of Foralumab is a very attractive approach as it may provide local action to treat gut inflammation in patient with CD. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting.

"The prevalence of inflammatory bowel disease is rising globally, imposing a significant burden both on patients as well as healthcare systems worldwide," said Sy Pretorius, MD, Parexel Executive Vice President and Chief Medical & Scientific Officer. "We're excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn's patients with another option in their repertoire of treatments to combat this devastating disease."

Recently, Tiziana announced positive results from its Phase 1 study showing that oral treatment with Foralumab was well-tolerated in healthy volunteers, with no drug-related safety issues even at the highest dose of 5 mg2. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies3,4. Importantly, oral treatment with OKT3, a mouse anti-CD3 mAb, showed clinical responses which were reversed following discontinuation of treatment, suggesting oral treatment with OKT3 may have potential for treatment of moderate to severe ulcerative colitis5.

Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences, commented:

"Previously, we reported that oral administration of Foralumab was well-tolerated and that the treatment did not result in severe toxicities that are so commonly observed with intravenous (IV) administration of anti-CD3 mAbs, suggesting that oral administration may be able to minimize toxicities and thereby improve clinical outcome. Our patent on the core formulation technologies covering alternative routes of administration for immunotherapies has been already granted in the USA and it is pending in other countries world-wide. 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."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.