When we have a cold or a headache, we pop a pill. We get sick, we go to the doctor and get a shot. Taking medication orally via a pill or getting drugs injected via a syringe are some of the oldest forms of delivering therapeutic molecules. In the past, “drug delivery” simply meant getting the therapeutic inside the patient,whereas now it has evolved to include “controlled release,” allowing control over the timing, dosage and also location of drug release.

A transformation in the field of controlled release is being pioneered by Mimetics Solutions, LLC (Austin, TX), with the development of their proprietary Affinimer™ technology. This technology shifts the current controlled release paradigm from one of passive delivery (typically releasing one drug at a single dosage over a range of time) to a “smart” active delivery system where a therapeutic molecule is released in response to a specific stimulus. Current drug delivery technologies allow controlled dosing of a molecule of interest but are limited in that they don’t respond to actual biological status so there is no feedback loop. This is fine if you need 200 mg of aspirin every 4 hours, but doesn’t help if you need 200 mg of X only when Y reaches levels of Z. The Affinimer™ technology addresses these complex biological processes by creating smart biomaterials that deliver the therapeutic molecule of interest only when necessary, and can be turned off when the stimulus is gone. Also, instead of delivering a set dose over a set time period, this mimetic release would deliver only in response to a target stimulus.

Mimetic Solutions has identified diabetes as their first therapeutic indication, and is already developing the GlucoSmart™ product for glucose triggered release of insulin. Their products will completely change how diabetic patients treat their disease, as this therapy would automatically respond to glucose levels and eliminate the need for constant self-testing and dosing, giving patients much greater flexibility – all without an implantable glucose monitor or pump. There is a tremendous demand for longer-term delivery as patients prefer weekly or monthly injections to daily injections. With less testing required and fewer injections, the overall patient cost would likely drop dramatically (glucose test strips alone can cost $20-30 per week), and the product would have the potential for higher reimbursement and thus premium pricing if it removes other costs from the therapy. The success of a product like GlucoSmart™ would depend heavily on whether this would be formulated as a one-day or longer-term therapy (week, month or year-long delivery).

It is not yet clear if Mimetic Solutions is developing this technology platform as a bolus injection or implantable device for longer-term delivery. It is also unclear how the amount of drug delivered would be monitored and how often these smart devices will need to be replaced as the amount of drug delivered will depend on the individual. However, this smart, mimetic release of therapeutics should be able to be productized for different diseases in different ways.

In another ‘smart’ move, Mimetics is also pursuing the cosmetics area where their technology can be applied to the controlled release of fragrances, vitamins or anti-aging compounds. This will generate early stage revenues as these products are much quicker to market, giving Mimetics the cash to develop their therapeutic pipeline. As we begin to understand the regulatory aspects of new technologies such as these (is this a combination product, or is the polymer considered an excipient?) we will attempt to outline them here at The Regeneration Station.