(Alliance News) - Biotechnology company Tiziana Life Sciences PLC said Thursday completion of phase one clinical study of Foralumab in healthy subjects showed it was "well tolerated" at all doses tested.
Foralumab, a fully human anti-CD3 monoclonal antibody mAb, is intended to treat autoimmune and inflammatory diseases and is delivered in enteric-coated capsules.
The phase one clinical trail, conducted at the Brigham & Women's Hospital at Harvard Medical School in Boston, Massachusetts, was a single-site, double-blind, placebo-controlled, single ascending dose study in healthy subjects, the company said.
During the study Foralumab was orally administered at 1.25 milligrams, 2.5 milligrams and 5.0 milligrams per dose as enteric-coated capsules.
"All subjects completed the trial without any safety concerns at any of the doses," the company said.
Previously, the company had said a phase one trial of a nasal dose of Foralumab showed the drug "was well-tolerated at all doses".
Kunwar Shailubhai, chief executive officer and chief scientific officer, said: "Successful completion of this study is a significant milestone to validate our proprietary technologies of oral and nasal administration of mAbs, which we believe could potentially be transformational for future developments of mAbs therapeutis."
"These findings provide the scientific rationale for our core technologies of oral and nasal formulations of mAb therapeutics," Shailubhai said.
Tiziana Life Sciences shares were down 8.5% in London at 37.50 pence each on Thursday.
By Loreta Juodagalvyte; loretajuodagalvyte@alliancenews.com
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