SAN FRANCISCO—After working on cystic fibrosis medicines during her 15 years at Vertex Pharmaceuticals, Patricia Hurter was ready for retirement. In April last year, with the company’s latest offering, Trikafta, en route to FDA approval, she bade the company and her “intense” lifestyle adieu.
“It was a very, very intense time … It was great while I was there and I enjoyed it; I just thought I had to change my lifestyle a bit,” Hurter, who goes by Trish, said at the annual J.P. Morgan Healthcare Conference. The plan was to join some boards or work on a virtual company—jobs that could be done from anywhere in the world.
Then, Lyndra Therapeutics, the Bob Langer spinout working on an ultralong-acting pill, came knocking. Hurter thought she was meeting with then-CEO Amy Schulman for a chance to join Lyndra’s board. Turns out, Schulman was recruiting Hurter to replace her as chief.
About the size of a fish oil capsule, the pill is designed to continuously release one or more drugs in a patient’s stomach over the course of a week or longer. After a patient swallows it, the outer capsule dissolves and the pill opens up into a star shape, which prevents it from being passed. It sticks around for a predetermined time, such as a week or a month, all the while releasing the drug from the prongs of the star. Once its time is up, the star loses its stiff shape and travels through the gut. As one can imagine, the possibilities are many.
“It’s just an embarrassment of riches in terms of opportunities,” Hurter said.
A native of South Africa, she was struck by the global public health applications, including as a long-acting malaria treatment, birth control pill or HIV-preventing medicine. Stateside, the pill could help people who have chronic diseases like hypertension but are bad at taking their medicine as prescribed or those with substance use disorder who struggle to show up at a methadone clinic every day for treatment.
“We are a split-personality company—we’re interested in the developing world, but we have to do things here as well,” she said.
In addition to its long-acting nature, the pill's controlled release could resurrect drugs consigned to the scrapheap because they take too long to absorb.
“Some drugs have a narrow absorption window. The small intestine is where most drugs are absorbed, but they’re in the small intestine for three to five hours and then in the colon for 12 to 24 hours,” Hurter said. That means no matter how much drug a pill holds, a patient’s body can only absorb so much of it during those three to five hours.
“[The pill] makes drugs work that wouldn’t have worked before because nobody wants to take a drug five times a day,” she added.
Hurter joined the company on a part-time basis last summer—to be able to work around her planned post-retirement trips—and came on full-time in September. At the time, Lyndra had completed a $55 million series B to propel its schizophrenia program into phase 2 and brought on partners including Gilead Sciences for HIV and Allergan for Alzheimer’s disease. It was in the prototyping phase, which was good enough for phase 1 studies, Hurter said. In the run-up to phase 2, she will build up the company’s manufacturing chops.
“Traditional pharma manufacturing alone is not going to be enough. We are going to be innovative. We will be using different materials than people normally use for tablets and capsules,” Hurter said. Lyndra’s early prototypes were assembled manually and very slowly; the company is working on an automated way to scale the process up. It’s also tweaking the pill’s design, aiming to land on one by the end of the year, in time to start later-phase clinical studies in 2021.
And it’s not stopping there.
Hurter hasn’t spent too much time mulling distribution models yet, but it’s on the to-do list as Lyndra's programs mature.
“How do we want to commercialize these things? It’s not going to be traditional, with multiple middlemen taking their cut,” she said. “It’s important in trying to solve global health problems. We have to have affordable access for people—we can’t be allowing distribution models where everybody is taking a pound’s worth of flesh from patients who are just trying to be healthy.”