Chinese Regulators Tentatively Approve Novel Alzheimer's Drug — The First Since 2003

Even as high-profile, cash-rich pharma companies struggle with their Alzheimer's programs, a little-known Chinese biotech seems to have made a big breakthrough by obtaining regulatory clearance for its Alzheimer's drug.

First Drug In 16 Years

Shanghai Green Valley Pharma announced Saturday that the National Medical Products Administration, or NMPA, of China has approved the drug Oligomannate for the treatment of mild-to-moderate Alzheimer's disease and improving cognitive function.

Oligomannate, an oligosaccharide derived from seaweed, was reviewed through the fast track channel. The company said it is the first approved novel drug globally to treat Alzheimer's since 2003.

Green Valley said it will make the drug available in China by the end of 2019.

The approval was granted based on the results of the Phase 3 trial, which demonstrated Oligomannate's ability to improve cognitive function in mild-to-moderate Alzheimer's disease in patients as early as week four, with the benefit sustained at each follow-up assessment visit.

"There are only few drugs available to treat Alzheimer's disease, and none can delay or prevent progression of the disease," Professor Xiao Shifu, a leading principal investigator of the Phase 3 trial of Oligomannate, said in a statement. 

"The results of the Phase 3 clinical study showed rapid onset of efficacy of Oligomannate within four weeks, and that patients' cognitive function continued to improve. The treatment was safe during the 36-week clinical trial."

The company now has to submit follow-up data on pharmacology and long-term safety and efficacy to remain in the market.

A Novel Approach

Green Valley said its Oligomannate has a distinctly different mechanism of action from the other Alzheimer's agents that are on the market and in clinical trials.

Most drugs target amyloid plaques and neurofibrillary tangles, which are considered the common underlying causes of the disease.

Oligomannate reconditions dysbiosis of gut microbiota, inhibits the abnormal increase of intestinal flora metabolites, modulates peripheral and central inflammation, reduces amyloid protein deposition and tau hyperphosphorylation and improves cognitive function, according to the company. 

Following the Chinese launch, the company also plans to submit marketing authorization approvals in select countries.

The company said it aims to initiate a multicenter, global Phase 3 study in the U.S., Europe and Asia in early 2020 to support its global regulatory filing.

Related Links:

The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight

Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates