Fresh off of changing its name and posting some positive clinical results, Aimmune Therapeutics has picked up the FDA's coveted breakthrough therapy designation for its peanut allergy treatment, promising a speedy regulatory process for the company's lead drug.
Aimmune's candidate, AR101, is an oral therapy that uses a slow, steadily up-dosing regimen of pharmaceutical-grade peanut proteins to re-educate the immune system. In a placebo-controlled Phase II study conducted this year, the treatment met its primary endpoint of desensitizing patients to peanut proteins, and Aimmune is now blueprinting a Phase III trial in hopes of duplicating those results in a larger population.
The FDA's breakthrough tag guarantees the biotech access to top industry officials as it moves into late-stage trials and promises a shorter review process if and when Aimmune files AR101 for approval. The agency's program is designed to speed up the pace of development for treatments that address a serious unmet need in medicine.
|Aimmune CEO Stephen Dilly|
"Currently, there are no approved medical therapies to treat the more than 2 million children and adolescents in the United States and Europe with peanut allergy who are vulnerable to reactions from accidental exposures," Aimmune CEO Stephen Dilly said in a statement. "We are eager to continue working closely with the FDA and to receive its guidance to help make AR101 available to patients as soon as possible."
Aimmune, formerly Allergen Research Corporation, is at work on a pipeline of what it calls characterized oral desensitization immunotherapies, or CODITs. Unlike post-reaction treatments like epinephrine, CODITs work by gradually diminishing the body's response and eventually rendering patients desensitized to clinically meaningful levels of food allergens. The Brisbane, CA, biotech has also disclosed early-stage projects in egg and milk allergies.
The company is working off of an $80 million B round closed in March, cash it has earmarked to fund AR101's Phase III. Aimmune's backers include Foresite Capital, Longitude Capital, Fidelity, Aisling Capital, Adage Capital and RA Capital Management.
- read the statement