UPDATED: Takeda GI spinout nabs approval for only drug — and pivots to a quick raise
Three years after Frazier teamed up with Takeda to spin a gastrointestinal drug into a new startup named Phathom Pharmaceuticals, the biotech has delivered an approval.
The FDA has sanctioned two different formulations of vonoprazan to treat H. pylori infection in adults: Voquezna Triple Pak combines vonoprazan tablets with amoxicillin capsules and clarithromycin tablets, while Voquezna Dual Pak contains only vonoprazan and amoxicillin.
And shortly after announcing the approval, Phathom followed it up with plans to raise up to $260 million. It’s a tactic being used more frequently as the biotech bear market continues to maul public companies, where positive data or good regulatory news is quickly succeeded by nine-figure raises.
The $260 million consists of $100 million upfront and another $160 million promised upon approval of vonoprazan in erosive esophagitis. Phathom says the cash will be used to boost the commercial launch in both indications (an EE decision is expected in Q1 2023) as well as an EE Phase III study.
Phathom was among the first in a string of biotech spinouts Takeda launched — often with the help of Frazier — to handle some of the pipeline assets that the Big Pharma didn’t have the bandwidth for but thought was still worthwhile.
Approved in Japan in 2015, vonoprazan belongs to a class of products known as PCAB, or potassium-competitive acid blockers. By blocking the potassium-binding site of gastric hydrogen potassium ATPase (also known as the proton pump), which is the enzyme largely responsible for acidification of the stomach, it’s designed to overcome many of the perceived weaknesses of traditional proton pump inhibitor therapy.
In a Phase III trial, both vonoprazan regimens were pitted against one such traditional therapy, Prevacid, and showed “superior eradication rates,” said CEO Terrie Curran in a statement.
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” she added, noting that the Voquezna products would bring more options to millions in the US.
Phathom is touting the therapy as the first acid suppressant from a new drug class approved in the US in over 30 years.
This story has been updated with details of Phathom’s $260 million raise.