---
title: "Regulatory Hurdles Strain Montana's New Right to Try Expansion for Rare Genetic Condition"
url: https://projectchintan.com/article/regulatory-hurdles-strain-montana-s-new-right-to-try-expansion-for-rare-genetic--i3xyu
publisher: Project Chintan
author: Project Chintan Newsroom
published: 2026-07-31T09:00:00.000Z
modified: 2026-07-31T12:02:39.020Z
language: en-IN
---

# Regulatory Hurdles Strain Montana's New Right to Try Expansion for Rare Genetic Condition

Kris DeVault faces a ticking clock to secure an experimental French nasal spray for his son, Brody, who has a rare energy-depleting condition. While Montana's expanded 'right to try' laws offer a potential path, the drugmaker's fears of FDA retaliation create a significant bottleneck.

## Key takeaways

- Creatine transporter deficiency (CTD) leaves children with severe speech and motor delays by preventing energy from entering the brain.
- A Montana law passed in 2023 allows non-terminal patients to access experimental drugs that have only completed Phase I safety trials.
- French biotech Ceres Brain Therapeutics is hesitant to provide its nasal spray under Montana law due to potential negative impacts on FDA approval.
- Phase II trials for the experimental CTD treatment are slated for France, leaving American patients with no immediate legal access path.
- The lack of domestic options is forcing families to consider unregulated offshore clinics in countries like Honduras for experimental therapies.

## A Battle Against Biological Time

Three-year-old Brody DeVault lives with creatine transporter deficiency (CTD), a rare genetic disorder that starves his brain and muscles of the energy required for basic development. Born in March 2023, Brody missed early milestones in motor skills and speech; today, he remains non-verbal and physically frail, with muscle strength lagging behind that of his nine-month-old sister. His father, Kris DeVault, observes that Brody struggles to communicate basic needs or even physical pain, recently standing unresponsive while being bitten by fire ants.

The central concern for the DeVault family is the rapidly closing window of neurological plasticity. Scientists recognize the first few years of life as the most active period for brain development. If Brody does not receive treatment soon, the cognitive damage from CTD may become permanent.

## The Promise and Risks of Ceres Brain Therapeutics

Ceres Brain Therapeutics, a French biotechnology firm, has developed a nasal spray designed to bypass the blocked pathways in CTD patients and deliver creatine directly to the brain. While CEO Thomas Joudinaud reports successful results in mouse models and a completed Phase I safety trial involving 48 healthy adult volunteers, the drug remains unproven in children or symptomatic patients.

Accessing the treatment through traditional channels is currently impossible for the DeVaults. The upcoming Phase II trials are scheduled for France, and the drug is not registered with the American Food and Drug Administration (FDA). Furthermore, current manufacturing processes do not meet FDA regulatory standards, making the drug ineligible for the agency's existing expanded access programs. Joudinaud anticipates it will be several years before the drug reaches the U.S. market.

## Montana’s Legal Experiment Faces Practical Barriers

In 2023, Montana expanded its "Right to Try" framework beyond terminal cases to include patients with chronic or developmental conditions, provided the requested drug has cleared Phase I safety trials. This shift established an Experimental Treatment Review Board (ETRB) to vet applications. However, legal theory has yet to translate into patient access. Joudinaud expresses concern that participating in Montana’s program without explicit FDA approval could jeopardize the drug's future federal registration.

As the Montana ETRB prepares to review its first applications, the standoff has pushed Kris DeVault toward high-risk alternatives. He is currently investigating an offshore clinic in Honduras to secure the treatment, a move many in the medical community caution against. For DeVault, the risk of an unproven drug or an offshore procedure is outweighed by the certainty of his son's decline without intervention.

Source: MIT Technology Review

---
Canonical: https://projectchintan.com/article/regulatory-hurdles-strain-montana-s-new-right-to-try-expansion-for-rare-genetic--i3xyu
Reported from: MIT Technology Review