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by Robert MacKay, Sunday, October 27, 2013 | Categories: Tesofensine

We have written about the potential weight loss drug Tesofensine in the past and we have now become aware of an issue with the Phase II clinical trials in Denmark that we should expose to our readers. Tesofensine was shown to induce an impressive level of weight loss over a 6 month period at the top dose administered. The average weight loss at the top dose was 10.6% over the 6 month period. Even at the lowest daily dose, the average weight loss of just under 5% over 6 months is not too bad.

The problem with the study is that irregularities were discovered at two of the datacentres where adverse events may have been under-reported as members of staff were wrongly instructed not to record events if the patients had experienced similar side effects before randomisation on the trial. Clearly this instruction was wrong and could potentially undermine the apparently good safety profile of this medication.

The Danish company that holds the patent for Tesofensine is still looking for a partner to develop this medication. It is our understanding that protocols for a Phase III trial have been agreed with regulators but no partner has been found so the drug is in a state of limbo. Given that Tesofensine has a mode of action similar to the now withdrawn Sibutramine (Reductil), the patent-holder may continue to experience difficulties in recruiting a partner and the irregularities in the Phase II trial sites can only exacerbate matters in our view.

by Robert MacKay, Wednesday, June 8, 2011 | Categories: Tesofensine

The Danish bio pharma company, Neurosearch, will not seek to develop tesofensine, the obesity drug, by itself and instead seeks a partner in order to continue development with a view to eventually getting it on the market following the guidance of the FDA and EMA in the form of the outline of a clinical development programme.

The new phase III study that would be required by the company to carry out would involve two studies on obesity, each for the duration of one year. A study, longer than 2 years in duration, would also have to be carried out in order to assess the safety profile of the drug in terms of cardiovascular events.

The drug has in the past been shown to cause significant weight loss and boasts a safety profile that the company is confident will be borne out in wider trials. The big pharmaceutical companies are not ready to give up on their weight loss treatments despite previous failures before the FDA especially at a time when there are so few options available to those suffering from obesity. The question is, who will partner up with the Danish company and when? The market is arid right now and desperate for a breakthrough.

by Robert MacKay, Thursday, November 18, 2010 | Categories: Tesofensine

Neurosearch, a Danish biopharmaceutical company that researches drugs, which act on the central nervous system, had been preparing to commence phase III trials of their obesity drug Tesofensine. Considering the difficulties faced by other drug companies recently in terms of regulation (notably Sibutramine, which works in a similar way) and the cost of phase III trials, Neurosearch will not continue to prepare for trials without a partner.

The safety profile of Tesofensine is relatively similar to other recent obesity drug candidates but the impressive weight loss results meant that the phase III trials were something to get excited about. Until Neurosearch receives the financial backing that they need, Tesofensine will be yet another promising obesity drug that has fallen before it even gets to the last hurdle.

by Robert MacKay, Thursday, February 18, 2010 | Categories: Tesofensine

Neurosearch, the experimental drug company, has announced that they are continuing with plans to launch Stage III trials into their new slimming pill, Tesofensine.

The drug acts in three different sites in the brain and increases the transmission of three neurotransmitters to the brain, dopamine, noroadreneline and seratonin. All the neurotransmitters act on appetite and metabolism.

Dopamine acts to send the brain messages about the pleasure derived from food, while noroadreneline and serotonin increase metabolism and reduce appetite.

The company has already published promising results from Stage II trials in the respected medical journal The Lancet, which showed that the results achieved by the drug were comparable to that of the successful slimming pill, Reductil. Reductil however was recently withdrawn from sale after concerns about safety.

The decision of the European Medicines Agency to withdraw Reductil has affected Neurosearch, with shares in the company falling by 5% when the decision was announced.

However the firm believes that its drug will meet FDA and EU safety requirements, with patients who took part in the trials experiencing few adverse side effects over extended periods of time. The most common side effects were dry mouth, insomania and stomach problems.

The Lancet study indicated however that members of the treatment groups could be more susceptible to changes in mood and agitation.

The company are carrying out ongoing analysis to combine safety data from two different trials, TIPO-1 and TIPO-4.

by Robert MacKay, Thursday, February 18, 2010 | Categories: Tesofensine

The Scandanavian drug company Neurosearch has announced that they will present their annual report on the 10th of March. The company is expected to announce not only positive results from their trials into a treatment for Huntingdon’s disease, but progress in their trials for the obesity drug Tesofensine.

Tesofensine is likely to considerably boost the company's profile, as well as its market worth, as trials continue. Already data from early stage trials showed that patients taking the highest doses of the drugs lost up to 12.8kg over the course of treatment, twice what people taking Reductil lost in clinical trials.

Researchers first became aware of the drug when they were running trials into its effects on patients with Parkinson’s and Alzheimer’s disease.  They noticed that patients experienced unexpected weight loss and so trials were launched into its potential as a weight loss drug.

The medication works by changing how three chemicals, noroadreneline, dopamine and serotonin, send messages to the brain. They reduce appetite and improve sensations of being full, which make patients more likely to eat less.

It is believed that of three doses of the medication which have been trialled, the middle dose has the best results, achieving optimum results while causing the least amount of side effects. Reported side effects have included dry mouth, nausea and blood pressure increases at the highest dose.

If the medication continues to be successful in trials, then there will be a considerable market for it. Obesity is a growing worldwide problem, with 1 in 3 Britons expected to be overweight by 2012. Recently Reductil, also an appetite influencing medication, was withdrawn from sale, meaning that there is a considerable unfilled demand for a product that would support obese patients' efforts to eat less.

However the drug is not expected to complete clinical trials and be approved for a few years, though investors will be keen to hear Neurosearch’s update on progress.

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