Aeglea BioTherapeutics may be turning a corner. The biotech has managed to sell off its rare metabolic disease asset—which the FDA denied approval for last year—to Immedica Pharma for $15 million cash and the potential to make up to $100 million in milestones.
Swedish pharma Immedica has snapped up global rights to Aeglea’s pegzilarginase, an investigational recombinant human enzyme designed to treat Arginase 1 Deficiency (ARG1-D), a rare metabolic disease.
Last year, the company received a refusal to file letter from the FDA after asking for approval of pegzilarginase. In the letter, the drug agency requested more efficacy data and further information about chemistry manufacturing and controls.
Now, the Massachusetts-based biotech has managed to offload worldwide rights to Immedica for $15 million upfront and up to $100 million in milestone payments that are contingent on formal reimbursement decisions by national authorities in European markets and FDA approval, among other events. The sale overrides a previous licensing agreement between the two in which Immedica held licensing rights for the asset in European and Middle Eastern markets.
Immedica will continue development efforts for pegzilarginase and hopes to gain European market approval, Aeglea Chief Financial Officer Jonathan Alspaugh said in a July 27 release. Immedica will also maintain discussions with the FDA about a path forward for pegzilarginase in the U.S., according to Alspaugh.
It could mean that Aeglea’s streak of bad luck is turning around. The biotech seemed all but shuttered early this year after disappointing data from rare disease med pegtarviliase prompted a third round of layoffs in a one-year period. The company shed almost all remaining staff, leaving only 10 employees standing, and was exploring its strategic alternatives.
It turns out one of those alternatives was taking a seat at the buyer’s table. In late June, the rare disease company said it was pivoting to immunology, acquiring Spyre Therapeutics in a stock swap deal. The deal gave Aeglea access to the Paragon Therapeutics spinout's long-acting antibodies aimed at immunology, including two parallel lead programs set to enter the clinic in 2024. Both assets are being developed to treat inflammatory bowel syndrome.
Around the same time, Aeglea also drew in $210 million via a private placement, money that’s expected to extend the company’s cash runway into 2026.