March 18, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Among the many players trying to develop a drug to treat Alzheimer’s disease is a little-known company called TauRx Pharmaceuticals Ltd. based in Singapore and co-founded by Claude Wischik, a researcher at the University of Aberdeen in Scotland. Taking a slightly different approach than most other companies, TauRx hopes to present trial data on its experimental drug, LMTX, as early as July.
The two primary causes of Alzheimer’s disease are believed to be excess accumulation and “clumping” of beta-amyloid and a protein known as tau. Most drug research has focused on beta-amyloid. Wischik and TauRx have focused on tau.
The company has published six papers in technical publications, five of them published in the first half of 2015, that have outlined 10 years of clinical and preclinical work on LMTX, which is a second-generation tau aggregation inhibitor (TAI), currently in three international Phase III clinical trials.
“Since the completion of our Phase II studies and the announcement of our highly promising results back in 2008, we have been working towards our goal of bringing forward a tau-targeted approach into final stage clinical trials,” Wischik said in a statement in June. “Now these publications provide the long-awaited data from our efforts, which collectively chronicle that journey.”
Although Alzheimer’s drug research has been a barren wasteland of failed studies, with more than 123 failures in various trials reported between 1998 and 2014, there are some fairly high-profile companies pursuing this area.
Indianapolis-based Eli Lilly and Company just announced this week that it had changed the primary endpoints of its Phase III study of solanezumab for Alzheimer’s disease. It was shifting its focus primarily to cognition and somewhat away from metrics related to Activities of Daily Living (ADL). Solanezumab is a monoclonal antibody that appears to help clear the brain of amyloid beta early on in the disease.
Cambridge, Mass.-based Biogen announced late last year that it was making something of a pivot away from its highly successful multiple sclerosis (MS) franchise toward Alzheimer’s research. It has two identical Phase III clinical trials for its drug aducanumab ongoing with a total combined 2,700 patients. Aducanumab is also an antibody that targets beta-amyloid.
Mid-stage studies of TauRx’s LMTX have shown positive results, although it was not consistent with dosing. Patients that took 138 mg per day for 24 and 50 weeks showed positive cognitive benefits, but patients on a higher dosage of 228 mg didn’t show the same results. Wischik believes this was related to absorption problems, and were solved with a newer version of LMTX that is being used in the Phase III studies.
Wischik discovered this class of chemicals in the 1980s, noticing that they dissolved filaments of tau in test tubes. He partnered with several larger pharma companies, including what was at that time Zeneca, but it didn’t result in a drug, so Wischik decided to continue on by himself.
He co-founded TauRx with a friend of the family in Singapore and has raised about $500 million since 2002. The investors are primarily from Asia, particularly Singapore and Hong Kong.
“Looking for ways to prevent tau aggregation is definitely a viable path for drug discovery,” Rosa Sancho, head of research at the Alzheimer’s Research UK, told BloombergBusiness. And if the drug works and is safe, “for the field it would be incredible, there are no treatments at the moment and they are so desperately needed.”
If LMTX is effective and safe in these Phase III trials, and hence approved, it could be worth billions of dollars, although it is unlikely to end up being a sole cure for the disease. “The consensus of the field,” Wischik told BloombergBusiness, “is that ultimately some sort of cocktail will be necessary. There’s no winner-takes-all drug.”
At the moment company is privately owned, but Wischik and Tim Earle, TauRx’s chief operating officer, are aware that it will likely have to partner with a larger company to tap into its marketing and distribution networks. There is also some exploration of a possible initial public offering (IPO). Earle told BloombergBusiness that the company is engaging in “very exploratory discussions talking about concepts, talking about possible strategic choices that we may have to make as the Phase III results pan out.”
