As Lyndra Therapeutics mulls partnerships to build out its pipeline of central nervous system disorder treatments, it’s raised $60.5 million to move its lead program, a once-weekly pill for schizophrenia, into a pivotal trial.
The company plans to start that trial later this year and—if all goes to plan—is gearing up for a commercial launch in the U.S. “a few years later,” Lyndra's co-founder, former CEO and executive board chair, Amy Schulman, said in a statement.
The treatment, LYN-005, is an ultralong-acting version of the antipsychotic risperidone, which is typically given as a daily pill or an injection every two weeks. In a phase 2 study pitting LYN-005 against immediate-release risperidone tablets, Lyndra found that patients taking its version quickly reached therapeutic levels of the drug, according to data presented at the Congress of the Schizophrenia International Research Society in April.
The appeal of a once-weekly treatment that doesn’t involve needles is obvious. But Lyndra’s technology could also make drugs like risperidone work better with fewer side effects. Several investors have bought in, including AIG Investments, which led the funding round, alongside the likes of Gilead Sciences, Polaris Partners, Mass General Brigham Ventures and HOPU Investments.
In the phase 2 study, LYN-005 also reduced the peak level of drug exposure in the patients, an effect the company believes will be better for patients than traditional daily pills.
“If you take a daily pill, it’s like when you drink Coca Cola and get a sugar high—the pill dissolves in the stomach all at once and it’s absorbed in the upper part of the small intestine for about three to five hours,” said Lyndra CEO Patricia “Trish” Hurter, Ph.D., in a previous interview. “For the rest of the day, the body is just eliminating the drug, so you get these roller coaster levels of drug.”
At the top of the roller coaster, drug concentrations in the body are high, which can lead to unwanted side effects. But after the rush to the bottom, there may not be enough in the body for it to be effective. Lyndra’s technology is designed to continuously release one or more drugs in a patient’s stomach over time, keeping them in the Goldilocks zone of drug levels.
After the patient swallows the pill, the outer capsule dissolves, allowing it to open up into a star shape in the stomach. The shape stops the pill from being passed, so it stays in the stomach for a predetermined time, such as a week or a month, all the while releasing the drug from the prongs of the star. Once it’s done its job, the star loses its stiff shape and travels through the gut.
Besides LYN-005, Lyndra is working on several long-acting versions of approved drugs, including rosuvastatin, the cholesterol fighter sold as Crestor; dapagliflozin, the active ingredient in AstraZeneca’s oral diabetes drug Farxiga; and a combination of Alzheimer's disease drugs Namenda and Aricept (memantine and donepezil). It is also developing long-acting treatments for HIV and malaria as well as a long-acting contraceptive.
The company started with established drugs to “decouple” the safety of its technology from the safety of the drug, Hurter said. But once it’s shown its platform works, Lyndra could go into new chemical entities or partner with companies developing next-generation treatments for schizophrenia and other ailments. In the meantime, it sees plenty of work for itself turning daily pills into weekly or monthly ones.