Takeda and Amylin stop obesity trial
pharmafile | August 8, 2011 | News story | Research and Development, Sales and Marketing | Amylin, Takeda
Takeda and Amylin have decided to halt further studies of its combination treatment for obesity, due to ‘evolving dynamics’ within the therapy area.
The combination therapy of pramlintide/metreleptin – both analogues of the natural hormones amylin and leptin – was being investigated as an injectable treatment for obesity.
The joint decision was based on a commercial reassessment of the programme and the “evolving dynamics within the obesity therapeutic area,” both firms said, which had been in phase II development as a twice-a-day injection formulation.
The latest mid-stage dosing trial from 2010 suggested positive results for the treatment, in which patients who continued treatment with pramlintide/metreleptin for a total of 52 weeks demonstrated sustained weight loss compared to placebo.
While this programme has been discontinued, the companies said they would continue to investigate antibody-related laboratory findings with metreleptin treatment, in patients who participated in a previously completed clinical study of obesity.
This will continue the $1 billion deal between Takeda and Amylin formed last year, which aims to make treatments for a number of lifestyle diseases such as obesity.
Christian Weyer, senior VP of research at Amylin said: “The interplay of hormonal signals, such as amylin and leptin, plays a crucial role in the regulation of body weight.
“Advances in peptide engineering and delivery may help us leverage this biology to develop a therapy with less frequent dosing. With our partner, Takeda, we look forward to continuing to explore new options for the obesity market.”
Both Amylin and Takeda said they didn’t expect to revise the latest financial guidance for their respective 2011 fiscal years because of the halting of this trial.
Finding a successful obesity treatment has proven a difficult task for pharma, with Roche’s prescription form of orlistat (Xenical) the only major player in the weight loss market.
Trials of obesity drugs continually throw up serious side effects, with particular concerns revolving around the raised risk of cardiovascular problems.
This is why there have been no new obesity drugs in the last ten years with a series of firms – including Vivus, Orexigen and Arena – all suffering serious regulatory setbacks against their potential new weight loss drugs.
Ben Adams
Related Content
Von Willebrand disease – increasing awareness and access to vital care
Pharmafile talks to Anthea Cherednichenko, Vice President Franchise Head Haematology and Transplant at Takeda about …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
Takeda presents positive results from trial of chronic kidney disease treatment
Takeda Pharmaceuticals has announced positive results from a proof-of-concept study of mezagitamab (TAK-079) to treat …
