Pharma Start-Up Intrabio and CEO Mallory Factor Patently Mean Business

IAM recently profiled IntraBio CEO Mallory Factor and discussed the company’s recent patent dispute against Tesseract Medical Research.

Sterne Kessler Director, Paul Ainsworth, commented on the case, which involved IntraBio’s drug N-Acetyl-L-Leucine, a modified amino acid previously used for the treatment of vertigo. The drug received FDA approval in September 2024 and was awarded five years of new chemical entity exclusivity and seven years of orphan drug exclusivity.

“This amino acid was known in the prior art, but nobody knew that a modified form of it could treat rare disorders,” Ainsworth explains, “The outcomes from the clinical studies demonstrated why IntraBio came up with something new and innovative.”

During the first year of exclusivity, IntraBio discovered that N-Acetyl-L-Leucine was being marketed and sold as a dietary supplement by Tesseract. IntraBio, represented by Ainsworth, successfully filed a patent infringement suit.

“In marketing materials, Tesseract pointed to our clinical studies on the use of our molecule as a treatment of various rare diseases and cognitive disorders and presented that as reasons why customers should purchase their dietary supplement,” says Ainsworth. “They were promoting it for the very clinical purposes that IntraBio had FDA approval for and also obtained patent protection for.”

The case was settled in August 2025 with Tesseract agreeing to suspend any marketing and sales of their product. Factor states, “We will continue to bring enforcement actions to protect our investments and ensure our innovative therapies are available to patients without any contaminants.”