After failed phase 3, Accera appoints neuroscience vet to help revive fortunes

The biotech plans talks with the FDA in the near future, but the pair have a difficult past

Two months ago, Accera registered a late-stage flop for its much-derided “brain food” candidate AC-1204 in Alzheimer’s, but now the company is looking to doggedly keep going, and has taken on neuroscience veteran Judith Walker, M.D., F.R.C.P.(C), as its chief medical officer to try and make this med work.

Walker comes to Accera from biopharma service provider QuintilesIMS, where she was VP of product development for drugs in neurology and pain; previously, she was senior director of medical affairs at Teva’s neuroscience unit. She also served a stint at the neurology unit from German Merck unit Serono.

She has the credentials and the experience, but she will need it, as she faces a mammoth task: her new employer has charged her with leading its efforts on AC-1204, following its failure in March (and adding to the pile of failed Alzheimer’s medicines across the biopharma industry for the last decade), and trying to do it with a drug with that comes with some questionable science.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

In the recent phase 3 failed study, Accera enrolled more than 400 patients with mild-to-moderate Alzheimer’s and randomized them to receive daily doses of AC-1204 or a placebo.

The idea was to improve scores on an Alzheimer’s diseases scale by addressing the slowdown in cerebral metabolism associated with the condition. AC-1204 is designed to restore the energy supply to the brain by giving it a source of ketones to top up the dwindling power it derives from glucose.

In phase 2b, a subgroup analysis of patients who lack the APOE4 gene gave Accera the confidence to move into phase 3. But, like many big names before it, Accera has found it impossible to turn a hint of potential in phase 2 into success in phase 3.

Accera, again following a well-trodden path, has however refused to let the setback scuttle the program, and plans to keep going.

Prior to the results from the first phase 3, Accera was gearing up to start a second late-stage study that would tee it up to win approval in 2020. The plan now is to finalize the clinical development strategy for AC-1204 and discuss next steps with FDA. Its website still touts 2020 as the year slated for a potential approval.

That talk with the FDA will put Accera in the room with an agency that has slammed some of its activities. Accera began life as a developer of Axona, a product it marketed as a medical food for use in Alzheimer’s.

FDA hit Accera with a warning letter in 2013 on the grounds its marketing materials caused Axona to be classed as a drug. Accera continues to market Axona as a medical food for Alzheimer’s, but has tweaked its website since the warning letter.

Axona and AC-1204 both provide patients with a source of caprylic triglyceride—also known as fractionated coconut oil—that is intended to increase the availability of ketones to the brain. The potential of the therapeutic approach has enabled Accera to pull in more than $150 million from backers including Nestlé, according to SEC filings.

But this candidate has been met with much derision from bio-Twitter; Walker, however, is betting her career move that it will work out.

She said in a statement: “Accera has one of the few drugs in late stage development for Alzheimer's disease which addresses a differentiated and well-validated target. I am delighted to be joining Accera at this exciting time in the program.”

Suggested Articles

In this week's EuroBiotech Report, AstraZeneca plans 2020 lupus filing, Roche's SMA trial hits endpoint and Kiadis cuts staff in R&D pivot.

In our EuroBiotech roundup this week, NEC and Vaximm ink cancer vaccine pact, Compugen posts cancer data and Lunac raises cash.

Thermo Fisher Scientific has begun early talks to take over Dutch diagnostics maker Qiagen, according to reports.