Sadly, the Failure of Pfizer/Medivation’s Phase III Trial on Dimebon is not a Surprise To Curaxis Pharma
Today was an important day in the development of clinical trials for investigational drugs to treat mild-to-moderate Alzheimer’s Disease (AD). Pfizer/Medivation announced this morning the failure of their Phase III clinical trial of the investigational drug Dimebon. (For those who missed the news, see the story): Click Here
Although the announcement was not surprising to Curaxis Management or its scientists, it nonetheless is a difficult outcome for those suffering with this disease, and the families that care for and love them. Curaxis Pharma is dedicated to providing meaningful treatments for diseases of aging, including AD, and empathizes with the horrendous plight these families experience and the hope they hold onto for help.
We believe, as we did at the outset, that the data provided on this drug was flawed. Medivation in-licensed Dimebon, which is an antihistamine used in Russia for many years, from a Russian neuroscientist several years ago. Medivation then sponsored a Phase II study in Russia to determine effectiveness. The results of this study were very strong – so good in fact that their data showed results never before seen in any AD trial. Obviously, the scientific community was taken by surprise, and many wondered about the integrity of the Phase II trial and the related data.
Another major issue from Curaxis’ viewpoint was the lack of any consistent explanation of Dimebon’s method of action. Medivation could not really define how Dimebon worked and over time suggested a series of different possible methods of action. This seemed like a red flag to us.
Late last year Pfizer announced the drug Dimebon increased Beta Amyloid in the treated group. This seemed like yet another red flag, as most AD drugs in development seek to lower Beta Amyloid to treat AD.
The bottom line is that the failed Phase III trial of Dimebon, which was conducted at clinical sites in the United States and other countries, completely failed to duplicate the results achieved in the Phase II trial conducted in Russia and by a wide margin. Indeed, the results in the Phase III trial demonstrate absolutely no benefit for the group treated with Dimebon versus the placebo group. The doubts of the skeptics certainly seem validated.
Unfortunately for the families of those afflicted with AD, we do not believe subsequent trials for Dimebon will result in any different outcome. We believed from the beginning that the science was flawed and these results were the only inevitable conclusion.
What does this mean for Curaxis? As we have stated, the race to solve the challenge of AD remains wide open. It is a challenging and complex field with very few answers at this point. We believe that our product candidate, Memryte®, addresses each of the pathways through which the pathology of AD develops. We give some more detailed information in our video presentation and on our website, but suffice it to say that the evidence we have gathered to date is good enough to warrant taking our product into a Phase II trial of Memryte in women with mild-to-moderate AD planned for later this year.
In the field of complex and expensive medical research, there will always be failures. They are a necessary by-product of the ultimate success that we are convinced will come with a treatment for Alzheimer’s. We are on the path to combat this disease and to bringing a new and meaningful treatment to market for those suffering with AD.
Patrick Smith, Chairman and CEO
