Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m

Roche already has one Alzheimer’s candidate in its pipeline targeting tau, but has added a second via a deal with Belgian drugmaker UCB worth up to $2 billion.

The Swiss pharma group is paying $120 million upfront for exclusive global rights to UCB0107, an anti-tau antibody that is in a phase 1 trial in another disease – progressive supranuclear palsy (PSP) – but hasn’t yet started clinical development in Alzheimer’s.

UCB is retaining rights to UCB0107 in PSP, and will fund development of the drug through proof-of-concept studies in Alzheimer’s. At that point, Roche can either follow through with the license or return rights.

The drug becomes a backup to Roche’s semorinemab (RG6100), which is licensed from AC Immune and has already started two phase 2 trials in Alzheimer’s patients. One in early-stage (prodromal) patients – called TAURIEL – is due to generate results this year, and a second in patients with moderate symptoms is due to readout in 2021.

Tau is a protein that is found in cells of the central nervous system and is involved in the assembly and stabilisation of neuronal microtubules – channels used to transport substances to different parts of the nerve cell.

In Alzheimer’s the protein goes haywire, forming tangles that have been linked to cell damage and neuronal death. Tau tangles are one of the characteristic hallmarks of Alzheimer’s visible in the brain, along with amyloid plaques.

Most of the efforts of the pharma industry on funding Alzheimer’s therapies has focused on amyloid, with almost universally negative results. Some candidates remain in development, including Roche’s own crenezumab and gantenerumab, which remain in development despite negative trials.

Biogen and Eisai have already filed for approval of their amyloid-targeting antibody aducanumab, and while some analysts see the evidence for the drug as somewhat shaky, it has a chance of becoming the first disease-modifying drug to be approved for the disease.

Dozens of amyloid drugs have failed at the clinical testing stage, and as a result some drugmakers have turned their attention to tau protein as another possible therapeutic target for Alzheimer’s.

Along with Roche and UCB, other companies are working on tau. Furthest ahead is TauRx, which has a tau aggregation inhibitor called LMTX in a phase 2/3 trial (LUCIDITY) with results due in 2021 or 2022, although that drug failed to show a benefit over placebo in a phase 3 trial reported in 2016.

AbbVie has ABBV-8E12 in mid-stage testing, as does Biogen with its BIIB092 plus two other recently licensed drugs from Ionis and Sangamo. Meanwhile, Eli Lilly, AC Immune, Johnson & Johnson, Merck & Co, Anavex and Axon Neurosciences have other anti-tau drugs in early-stage clinical testing.

Roche’s head of pharma partnering, James Sabry, said the deal with UCB will “help expand our efforts on tau.”

He added: “Our commitment remains strong on exploring multiple approaches with the hope that our research and development, including this collaboration with UCB, will lead to a disease-modifying medicine that could positively impact millions of people with Alzheimer’s disease.”

UCB meanwhile says it plans to start a phase 3 trial of UCB0107 in PSP in the second quarter of next year.

PSP is a rare and progressive neurodegenerative condition that can cause problems with balance, movement, vision, speech and swallowing that also features a build-up of toxic tau in the brain.