Montana’s new “right to try” law can’t come soon enough for some

Brody DeVault, a three-year-old boy born in March 2023, has been diagnosed with creatine transporter deficiency (CTD), a rare condition that prevents his brain and muscles from receiving the energy needed for development. Despite this, his parents, Kris DeVault and his wife, are desperate to find a solution for Brody's developmental delays and struggles with communication, movement, and coordination.

A biotechnology company in France, Ceres Brain Therapeutics, is developing a drug for people like Brody, but it has only been tested in animals and a small group of healthy adults. The drug, administered as a nasal spray, has shown promising results in phase I clinical trials, but it has not been tested in people with CTD or in children.

As Brody, now three years old, continues to face significant challenges, his parents are exploring options to provide him with the experimental treatment. Montana has had a "right to try" law since 2015, which allows terminally ill patients to access unapproved drugs. In 2023, the state expanded this option to non-terminal patients who have undergone preliminary phase I clinical trials.

A new law in Montana aims to clarify how clinics can sell and administer these experimental treatments. The state's department of Health and Human Services has also finalized rules for these clinics. An experimental treatment review board (ETRB) is set to review Brody's application in the coming weeks. However, Ceres, the company developing the drug, is hesitant to apply for approval through Montana's program, worrying about potential conflicts with the FDA.

Brody's parents are now considering accessing treatment in Próspera, a private city in Honduras, where a clinic offers unproven stem-cell and gene therapies.