Transition Therapeutics Inc. (TSX:TTH/NASDAQ:TTHI) is in the process of developing an oral drug that has the potential to address both neuropsychiatric changes and cognitive declines associated with Alzheimer’s Disease and stabilize the mood swings of those suffering from Bipolar Disorder as well as a drug that plays a role in regulating obesity in those genetically predisposed to Type 2 Diabetes. With millions of people suffering from such health issues, and costing society billions of dollars in the treatment of same, such new drugs would be most welcome on all fronts. We wish Transition Therapeutics success in their endeavours and hope the development of each of their products come to fruition in rapid fashion. Here is their story to help you decide if its stock should be in your portfolio. Words: 1050
As you no doubt already know, Alzheimer’s Disease (AD) is a degenerative brain disease that affects over 5 million people over the age of 60 in the U.S. alone. The disease destroys neurons in the brain, debilitating the cognitive and functional processes as well as leading to neuropsychiatric disturbances. Unfortunately, no effective treatments are available to stem the progression of AD but Transition Therapeutics Inc. (TTH) hopes to change all that.
TTH is developing a small molecule compound, called ELND005, that is taken orally and uniquely provides a dual mechanism of action to address changes in cognitive, function and neuropsychiatric outcomes. A Phase 11 study has shown that:
- ELND005 significantly reduced the incidence of new neuropsychiatric symptoms in mild and moderate AD patients and
- a pre-specified sub-analysis of mild AD patients showed encouraging trends of efficacy on cognitive and functioning endpoints.
Elan, Transition’s licensing partner, has full control and responsibility for the development of ELND005. The Phase 11 clinical study data supports the commencement of pivotal studies in AD. Elan plans to announce a clinical study in second disease indication in addition to bipolar disorder. To see a short video on ELND005 Mechanism of Action in Alzheimer’s Disease go here.
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Bipolar Disorder (BPD), also known as manic depression, is a lifelong recurrent condition that causes dramatic shifts in mood, energy, thinking and behaviour. The cycles of mood swings can be from the highs of great excitement, euphoria, delusions, and overactivity (mania) on one extreme to the lows of devastating depression on the other.
The most severe form of BPD is bipolar 1 disorder (BPD 1), characterized by one or more manic episodes or mixed episodes and, often, one or more major depression. These mood episodes may last for several weeks or months, affecting patient’s ability to function. BPD 1 is also associated with increased cardiovascular morbidity and suicide risk. It is estimated approximately 3.5 million adults in the U.S. and E.U. suffer from BPD.
Currently available treatments for BPD include mood stabilizing drugs (lithium and valporic acid)that help control the highs and lows of the disease. Studies have suggested that these drugs may act by lowering the brain levels of an important cell signaling molecule, called myo-inositol, which is commonly found elevated in BPD patients and associated with bipolar patients.
ELND005 (scyllo-inositol) shares the myo-inositol-lowering mechanism with the above mentioned therapies. In clinical studies, ELND005 has been shown to reduce myo-inositol levels in the brain by approximately 45% compared to a 20-30% reduction generally associated with lithium and valporic acid. In line with the myo-inositol lowering effects, the mood stabilizing effects of ELND005 have been clinically demonstrated in patients with Alzheimer’s disease. During the 78-week treatment period in the study, the active group treated with ELND005 had lower incidences of new depression and anxiety compared to the placebo patients.
The above findings support clinical development of ELND005 in bipolar disorder. Moreover, the favourable safety and tolerability profile of ELND005 at effective doses, established from multiple clinical studies, provides an additional advantage over currently marketed bipolar drugs which tend to have unpleasant side effects such as weight gain, thyroid problems, nausea, vertigo, hypersensitivity, drowsiness, etc.. Thus, as a therapy, ELND005 has the potential to provide similar to superior efficacy and an improved safety profile over the bipolar drugs currently available on the market.
(In September 2006, Elan and Transition entered into an exclusive, worldwide collaboration agreement for the joint development and commercialization of Transition’s novel Alzheimer’s disease drug candidate ELND005. With its extensive experience and specialized knowledge of neuropathological disorders such as Alzheimer’s disease, Elan represents the most appropriate development partner for this clinical program.)
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Type 2 Diabetes
Obesity is considered to be the primary cause of Type 2 Diabetes (DM 11) in people who are genetically predisposed to the disease. As such, weight management is an important clinical objective for treating DM 11 patients as well as obese people.
Transition’s product, TT401, is a GLP-1 (glucagon-like-peptide-1) dual agonist which targets both the GLP-1 (a gut hormone secreted after meals and which plays an important role in regulating blood glucose) and glucagon receptors. These play integral roles in regulating appetite, food intake, satiety and energy utilization in the body. In preclinical studies, TT401 has been shown to effectively regulate blood glucose that is comparable to GLP-1 agonists. However, the distinct advantages of TT401 over GLP-1 agonists were the greater reduction in body weight and improved lipid profile in the blood.
In clinical studies, TT401 has shown an acceptable safety and tolerability profile as well as the ecpected pharmacological effects on glucose and other pharmacodynamic markers in non-diabetic obese patients. TT401 is currently undergoing a proof-of-concept study in obese diabetic patients that is expected in the first half of 2013.
(In March 2010, Transition acquired the rights to a series of preclinical compounds from Lilly in the area of diabetes. Under the licensing and collaboration agreement, Transition receives exclusive worldwide rights to develop and potentially commercialize a class of compounds that, in preclinical diabetes models showed potential to provide glycemic control and other beneficial effects including weight loss.)
For further information on the merits of Transition Therapeutics Inc. stock being in your portfolio you are encouraged to:
- visit their web site at www.transitiontherapeutics.com,
- email them at email@example.com,
- examine their financial results for the year ended June 30, 2012,
- review analyst coverage from 10 major investment companies,
- review their parnership arrangements with Elan and Lilly
- check out their latest stock quote.
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