Millions of people around the world are losing their hearing thanks to inner ear disorders and the pharmaceutical industry has spent years working to develop therapeutics to help address this patient population.
But Jeff Borenstein, lead scientist for drug delivery at Draper, discovered by talking to experts in the hearing loss field that many of the products in the industry’s pipeline fail because they rely on systemic administration. Scientists have struggled to get at the inner ear and locally deliver a targeted dose of a therapeutic.
“The folks from the hearing loss field were saying that there is progress in drug development in the pipeline – although nothing was clinically available at the time – but the problem was, how do you deliver those drugs? And the reason it’s so difficult is that the inner ear is among, if not the most, difficult place in the body to deliver drugs,” Borenstein told Drug Delivery Business News.
To tackle this delivery challenge, Borenstein and his team at Draper, in collaboration with clinicians at Massachusetts Eye and Ear Infirmary, spent 15 years developing an implantable and programmable intracochlear drug delivery device. Now, that device is ready to move into testing – and the team has come up with a unique way to get this technology to industry players.
Draper teamed up with CILcare and CBSET to form an industry-backed consortium. Between CILcare’s preclinical models for hearing loss and CBSET’s GLP-compliant laboratories, the group is hoping that pharma companies with hearing loss drug candidates will invest $50,000 for a two-year membership.
As part of the consortium, industry members can study their drug products with Draper’s device using preclinical models from CILcare and CBSET, according to the group.
“From Draper’s perspective, we are agnostic to the company and the compound – so we can actually partner with several companies and that’s the beauty of this technology. We have the ability to adapt and customize this technology depending on the type of compound,” Haleh Armian, business development & commercialization for biomedical solutions at Draper, explained.
“We think that this is really the missing link for drug development in hearing loss – the delivery of the drug,” Celia Belline, CEO of CILcare, added.
Instead of one company investing millions to bring the device to market, the team at CILcare, CBSET and Draper argue that everyone who spends $50,000 to join this consortium can participate in a “collective learning approach,” gleaning knowledge from each other’s development efforts.
There are both small molecule and large molecule drugs in development that are designed to tackle hearing disorders, Borenstein explained, and some of them are better suited for conventional delivery methods, like a direct injection.
“As you get into the emerging therapies, the biologics, the more complex growth factors, those are the ones that are really going to have trouble with the conventional means. These other companies will tell you they have injectable gels that are loaded with drugs and they can place them on a membrane, but as you get into these larger macromolecules, proteins, various antibodies, gene delivery, this is going to be really hard to deliver that way,” he said. “This is an agnostic delivery mechanism so if you can deliver them with this, directly into the inner ear, you’ve really overcome a huge obstacle.”
At the core of Draper’s device is a programmable, electromagnetic micro-pump that draws the drug from a reservoir and infuses it directly into the inner ear. The entire fluid volume in the inner ear is incredibly small – 12 microliters in the animal model that Draper has been working with, according to Borenstein.
Instead of simply pushing the total volume of drug into the inner ear, Borenstein’s micro-pump infuses a small volume of drug product, pauses and then withdraws an equal amount of fluid.
“That way, you can kind of effectively mix the drug into the inner ear without expanding the volume of the fluid that really small cavity,” he explained.
The group is still working on a form factor for the device. It could be wearable or completely implantable, Borenstein said.
In the device’s simplest form, it could have just one reservoir with a liquid formulation that is delivered on a regular basis. But the device could also have multiple reservoirs to target different types of cells within the inner ear, according to Borenstein.
If a company was concerned about drug stability, they could store powder and have on-board mixing in the device.
“It can become almost like a little chemical processing plant on a chip,” he said.
The device is programmable, which Armian pointed out could aid elderly patients who forget to take their medications or can’t make regular trips to the doctor’s office for their injections.
Peter Markham, president & CEO of CBSET, said he sees this device as more than just a way to deliver drugs. It could represent a way to help patients keep their hearing intact and make the most out of their time with loved ones.
“Elderly patients will often lose their hearing and then lose connectivity to their family members and to the outside world,” he said, “and they are almost accepting of that – we need to change that dynamic.”