Astellas has licensed a drug that could provide an alternative to surgery for tympanic membrane perforation (TMP)—commonly known as a ruptured eardrum—developed by California's Auration Biotech.
The Japanese drugmaker says it has taken a worldwide license to AU-935, a growth factor that emerged from the labs at Stanford University and could be used to make eardrums regenerate. TMP is generally caused by middle ear infections or trauma, or in people who have grommets fitted to prevent fluid build-up in the middle ear.
Most ruptures heal spontaneously, but some persist for months, and chronic TMP results in hearing loss in more than 50% of cases. At the moment, the condition is treated surgically by cauterizing the edges of the rupture, or plugging the hole using a tissue graft, although eardrops are sometimes used to manage discharge from the ear.
It's a big healthcare issue, with an estimated 100,000 surgeries carried out in the U.S. every year and around two thirds of graft procedures failing to repair the damage effectively.
AU-935 has the potential to be another option for those patients. It is based on heparin-binding epidermal growth factor-like growth factor (HB-EGF), a protein which is thought to play a role in wound healing.
Stanford University researchers reported in 2015 that HB-EGF was able to heal chronic TMPs in animal models, outperforming another growth factors—fibroblast growth factor (FGF)—that has also been tested for TMP.
Japanese drugmaker Nobelpharma is developing a formulation of FGF called NPC-18 for TMP that according to its website is in the latter stages of development, with marketing applications due later this year.
The two companies aren't talking about the financial terms of the deal but getting a big pharma partner on board is something of a coup for Auration—headed by life sciences veteran Ben McGraw who is also CEO at TheraVida—which was only set up two years ago. The firm has been pretty much flying under the radar but it emerges has been talking to Astellas about a licensing deal since 2015.
Astellas is paying an upfront fee, covering the cost of developing and commercializing AU-935, and committing to milestones and royalties on sales if the drug makes it through to market.