Singapore-based TauRx is expected to complete global Phase III trials this year for its Alzheimer's candidate, tau aggregation inhibitor LMTX, that will either start a new chapter in treatment or join a long list of flops.
Late last year, Claude Wischik, co-founder and executive chairman of TauRx, discussed the global trials with FiercePharmaAsia shortly after the company announced raising $135 million in new funding to support the effort.
Top-line results this year are the culmination of 14 years of work for TauRx, and even longer for Wischik, that has seen more than $300 million raised from small investors in Singapore and Malaysia as well as heavy hitters such as Singapore sovereign wealth fund Temasek and Malaysian casino operator Genting, which pitched in S$120 million ($83 million).
A recent Wall Street Journal report, confirmed by the company, said that TauRx has also approached bankers for a way to pay for development costs if the drug is successful in inhibiting the progression of Alzheimer's disease, including a possible whopping $15 billion Nasdaq IPO.
Wischik has strong views on what treatment options are likely to make it to the market in the coming years and while avoiding any comment on the progress of the trials so far, he offered a scenario that could see three main treatments in play for reimbursement prospects in the next 5 years.
For LMTX, a tablet aimed at dissolving tau tangles in the brain, data that showed a delay in the onset of Alzheimer's disease, particularly in early-stage patients, would be a significant breakthrough, Wischik said.
But he also noted that early-stage efforts are at work by Eli Lilly ($LLY) on its amyloid-targeted injectable drug solanezumab, even though the candidate flopped in Phase III trials this year.
He said the early stage space possibly remains open for Lilly, which the company mentioned in July citing an extension study of the failed trials, and added he would not be surprised if a push in that area led to an application to the U.S. Food and Drug Administration.
That leaves Eisai's Aricept, which fell off the patent cliff in 2010, and now sees generic donepezil made by companies such as India's Lupin for the U.S. market. The treatment is aimed at symptoms of Alzheimer's.
In all events, a reliable diagnostic for Alzheimer's eludes researchers, making the timing of any treatment a physician's call based on relatively standard assessment criteria in the clinic.
Wischik said that the state of play makes it possible that within the next 5 years the market could see a tau drug and an amyloid drug, both aimed at early stages, and generic Aricept fill out the tool kits for clinical use in symptomatic treatment.
"In a 5-year horizon I obviously think there will be early-stage treatments on the market," Wischik said, adding that clinical use would in large part depend on a doctor's assessment as long as a diagnostic tool eludes.
Still, as the WSJ noted, in the decade from 2002 to 2012, clinical trials for Alzheimer's candidates hit a fail record of nearly 100%, citing a study from the Cleveland Clinic Lou Ruvo Center for Brain Health and the Touro University Nevada College of Osteopathic Medicine.
- here's the WSJ story (sub. req.)