Acumen Pharmaceuticals is showing it has the business acumen to bring forward its Alzheimer’s disease drug candidate.
Investors seem to have taken stock of this on the company’s first day of trading. Acumen raised $160 million in its initial public offering Thursday morning after selling 10 million shares at the high end of its price range, and shares were skyrocketing 35% as of 1:01 p.m. ET.
Virginia-based Acumen finally reached the clinic this year with its antibody against amyloid-beta oligomers. It’s a long time coming for the Alzheimer’s candidate, ACU193, which emerged out of a collaboration with Merck that originally ran from 2003 to 2011.
The fresh proceeds will bankroll a phase 1 trial meant to produce data by the end of 2022. A phase 2 portion of a phase 2/3 clinical trial will then commence in 2023, Acumen has said.
Those phase 2 data could lead Acumen to seek accelerated approval, considering Biogen won approval last month for Aduhelm under the accelerated approval pathway. Biogen’s landmark win, considered one of the FDA’s most controversial drug approvals in recent memory, sparked a boon for other Alzheimer’s drug candidates that previously didn’t have quite a rosy outlook.
Last week, Eli Lilly said it would file for accelerated approval of its Alzheimer’s therapy candidate, donanemab, later this year. Biogen and its Japanese partner Eisai won an FDA breakthrough-therapy designation for their anti-amyloid beta protofibril antibody. And, also last week, Bristol Myers Squibb put its foot in the door with a payment of $80 million to Prothena to opt in on a license for anti-tau therapy PRX005.
Acumen’s IPO arrived the same day speculation emerged around Roche’s Alzheimer’s drug hopeful. The Swiss Big Pharma shot down rumors about an early approval filing that circulated from a Jefferies research note, saying it was focused on a phase 3 trial for gantenerumab.
Acumen’s potential FDA approval would likely be years behind Biogen’s and would fall behind Lilly’s, if donanemab gets the nod, which would put Acumen in the difficult position of needing to prove ACU193 different from those already on the market. Competing with a $56,000-a-year drug could be a hefty battle.
In its IPO filing, Acumen said ACU193 hardly binds with amyloid plaque and instead is meant to narrow in on amyloid-beta oligomers. This means the drug reaches the primary toxin behind the initiation and propagation of Alzheimer’s, the company claims, making it less likely to produce amyloid-related imaging abnormalities.