Aerie Pharma—just months away from a possible approval for its lead glaucoma drug—is hoping to unlock the potential of a key pipeline compound with help from Netherlands company Royal DSM.
Irvine-based Aerie thinks that a polymer implant technology developed by DSM could make the difference to AR-13154, a Rho kinase (ROCK) and protein kinase C (PKC) inhibitor that has shown promise in preclinical studies as a treatment for wet age-related macular degeneration, a leading cause of sight loss.
Aerie says AR-13154 has matched VEGF inhibitors such as Novartis' blockbuster Lucentis (ranibizumab) and fast-growing rival Eylea (aflibercept) from Bayer and Regeneron in these early-stage trials and could also have potential in combination with them. But it seems delivery is a pressing issue, and it wants to trial implants based on DSM's polyesteramide polymers (PEA) that are tiny but can deliver drugs over several months in the eye.
"A key to unlocking the potential of AR-13154 and related Aerie-owned compounds for the treatment of retinal diseases is the identification of the appropriate technology to achieve longer-term sustained delivery of our small molecules to the back of the eye," said CEO Vicente Anido, Ph.D., who added that the company is "hopeful that DSM's PEA … may prove to be that technology."
The new deal comes as Aerie is on the final straight in its bid to bring glaucoma treatment Rhopressa (netarsudil) to market, after a turbulent development pathway. A phase 3 trial failure in 2015, a successful bid to persuade the FDA to lower the bar on a second late-stage trial, and the withdrawal of a marketing application in 2016 because of issues at its contract manufacturer for the drug have held up the program.
Aerie got ROCK and norepinephrine transporter (NET) inhibitor Rhopressa back on track and refiled its application in February, and is now hoping for a positive verdict from the U.S. regulator in the first quarter of 2018. That would give the biotech a shot at pitching its once-daily therapy against glaucoma therapies currently given twice daily, such as the beta blocker timolol, and see if earlier predictions of $1 billion sales potential for the new product are realistic.
Meanwhile, the company has two other phase 3 trials ongoing that are intended to support filings in Canada and Europe, and recently reported positive phase 3 trial for a follow-up glaucoma therapy—Roclatan (netarsudil/latanoprost)—that is due for filing any day now.
Aerie says it is well-financed to take its programs forward, ending the first quarter with close to $208 million in cash, with burn rate currently running around $25 million per quarter.