Transition Therapeutics, Inc. (NASDAQ: TTHI) is a biopharmaceutical company developing novel therapeutics for disease indications with large markets. The company’s leading drug candidate, ELND005, is designed to treat the agitation and aggression associated with Alzheimer’s disease and Down syndrome. Additionally, Transition is developing TT401, a metabolic drug candidate formulated to treat type 2 diabetes and its accompanying obesity. Through the continued development and clinical testing of these two products, the company is addressing medical markets that are currently underserved.
According to the Alzheimer’s Association, an estimated 5.3 million Americans of all ages currently suffer from Alzheimer’s disease. Among those individuals, up to 60 percent will develop behavioral symptoms, such as agitation or aggression, over the course of their lives. Transition is making progress towards improving the comfort of those affected by these symptoms through the continued development of ELND005. In a completed Phase II study, the drug candidate appeared to decrease the emergence and severity of these neuropsychiatric symptoms by reducing myo-inositol levels in the brain.
In March, Transition took a major step towards the commercialization of its leading drug candidate through the completion of absorption-metabolism-excretion (AME) and renal clearance studies. These trials are required by the United States Food and Drug Administration for the approval of nearly all drugs in development. In both cases, ELND005 demonstrated good safety and tolerability, clearing the path for more advanced clinical trials moving forward.
The company’s product pipeline was expanded in May when Transition announced that its wholly-owned subsidiary had acquired exclusive worldwide licensing rights to TT701, a selective androgen receptor modulator that’s been shown to significantly increase lean body mass and muscle strength in male subjects.
“The safety and efficacy profile of TT701 creates a number of development opportunities,” stated Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. “[The company] will initiate development and manufacturing activities to enable the start of a Phase 2 study in the coming months.”
Transition is expected to continue making progress towards the commercialization of its robust product pipeline moving forward. With Phase II clinical trials for three drug candidates in four unique indications ongoing, completed or upcoming, the company appears to be closing in on a significant opportunity to realize sustainable returns in the years to come.
For more information, visit www.transitiontherapeutics.com
