LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Transition Therapeutics, Inc. ("Transition") (TSX: TTH) (NASDAQ: TTHI), a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include:
  • ELND005: small molecule drug to enter Phase 3 for the treatment of Alzheimer's disease
  • TT401/TT402: long-acting GLP-1 dual agonists for type 2 diabetes that provide glycemic control, weight management, improved lipid profile and better GI tolerability
  • TT301/TT302: novel orally bioavailable aminopyridizines for rheumatoid arthritis, that inhibit multiple pro-inflammatory cytokines and chemokines

“Transition’s strong record of executing against their business model is quite impressive,” said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “They have a strong cash position, no debt, and their lead drug, ELND005, is poised to enter Phase 3 for Alzheimer’s disease in partnership with Elan, who are responsible for all Phase 3 costs, leaving only upside potential for Transition. With ELND005’s disease-modifying mechanism and oral dosing advantage, it is positioned to compete successfully in the burgeoning Alzheimer’s disease space, a market with potential to exceed $10 Billion in annual worldwide sales. Transition’s earlier stage pipeline includes diabetes compounds TT401/402 which have a highly compelling profile and TT301/TT302, which are positioned for success in rheumatoid arthritis as oral successors to the current biologic therapies.”

In a 53-page Initiation Report by LifeSci Advisors, the preclinical and clinical achievements of ELND005 to date are presented, as is a detailed analysis favoring use of the drug in early stage Alzheimer’s patients. The safety and pharmacokinetics of ELND005 has been evaluated in a total of nine Phase 1 studies in 161 healthy volunteers, including healthy elderly subjects. A recently completed Phase 2 study called AD201 was a randomized, double-blind, placebo-controlled, dose-ranging study for ELND005 in patients with mild to moderate Alzheimer’s disease. For AD201, mild to moderate patients, aged 50-85 years were randomized, and an open label extension of the study called AD251 is ongoing. The report also examines the rapidly changing landscape for drug development in the growing Alzheimer’s disease space, including the ongoing paradigm shift within the field regarding increasing use of biomarkers and the evolving perspective on selection of inclusion criteria and endpoints for clinical studies. Also emphasized is the importance of providing disease modifying therapy to patients at earlier stages of the disease, where the potential for patient benefit is greatest.

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