Trident Pharmaceuticals Announces Initiation Of Phase 1a Clinical Study Of HF1020

First-in-Man Study Commenced for Novel Biologic With Potential to Treat Autoimmune Disorders and Allergic Conditions

Boston, MA - (Marketwire) - Trident Pharmaceuticals Inc., a biotechnology company developing therapies for autoimmune diseases and allergic conditions, today announced the initiation of a Phase 1a study for HF1020, a first in class recombinant protein with immunomodulatory activity. HF1020 is believed to offer a novel approach for treating the underlying inflammatory pathology of autoimmune disease and allergic asthma, without causing systemic immunosupression.

HF1020 is an oral biopharmaceutical product which acts by inducing naturally occurring T-regulatory cells as a mechanism for selectively down-regulating the inflammatory response associated with allergic asthma, as well as autoimmune disorders, including rheumatoid arthritis, inflammatory bowel disease and psoriasis. HF1020 is a stable protein and is administered orally by capsule. In extensive pre-clinical animal safety and efficacy testing, HF1020 was safe and well tolerated, demonstrating positive effects on multiple disease parameters and efficacy endpoints in animal models of asthma, rheumatoid arthritis, inflammatory bowel disease and diabetes.

"Entering the clinic with HF1020 is an important milestone for Trident," said Dr. Robin Brown, Chief Scientific Officer of Trident Pharmaceuticals Inc. "Based on extensive published research and data from preclinical studies, we believe this drug has true disease modifying potential offering long term control of underlying inflammation to allergic asthma patients as well as broad applicability across a range of patients suffering from autoimmune disease."

The Phase 1a randomized, placebo-controlled, blinded, single-ascending dose escalation study is being conducted in the UK by Dr. David Singh, Medical Director at the Medicines Evaluation Unit in Manchester, UK and Professor of Respiratory Medicine and Clinical Pharmacology, University Hospital of South Manchester. The trial will involve 32 subjects, and is designed to investigate the safety and tolerability of HF1020 in healthy volunteers and to identify a dose that can be used in further Phase 1b and Phase 2a studies planned in mild-to-moderate allergic asthma patients.

Professor David Singh, Principal Investigator for the HF1020 study, said: "We are delighted that the clinical phase of this exciting new compound has begun. We anticipate that new compounds such as HF1020, when fully researched, will provide new therapeutic options to patients with asthma and autoimmune diseases."

About Trident Pharmaceuticals
Trident Pharmaceuticals is developing novel biopharmaceutical products to treat autoimmune disorders and allergic conditions by selectively down-regulating damaging inflammation. The Company's lead product candidate, HF1020, induces T-regulatory cells as a mechanism for selectively down-regulating the inflammatory response associated with autoimmune disorders, including rheumatoid arthritis, inflammatory bowel disease and psoriasis as well as allergic asthma. HF1020 is in Phase 1 clinical studies. Additional information about Trident can be found at www.tridentpharma.com.

SOURCE: Trident Pharmaceuticals