Gainesville, Fla.-based startup Etectrx Inc. has secured an FDA clearance for its ingestible event marker system, the ID-Cap system. The startup is following in the footsteps of Redwood City, Calif.-based Proteus Digital Health Inc., which pioneered the category. The Etectrx approach, however, obviates the need for a skin-worn patch to monitor a signal from an ingestible sensor delivered with medication that’s been taken. It is the first to transmit a signal directly from within the body to a receiver that’s worn on a lanyard.

The ID-Cap system is in a pair of clinical trials to ensure HIV drug compliance, one for prevention and the other for treatment. Etectrx plans to supply the empty capsule to specialty pharmacies for use as ordered by a physician with existing medication, which is expected to prove particularly useful for generic drugs such as those to prevent organ transplant rejection.

Market strategy

The startup also aims to start securing biopharmaceutical partnerships to pursue FDA approval as a drug-device combo for the use of the system in conjunction with a branded medication. Oral oncology drugs are a strong candidate on this front, since they are quite expensive and consistent adherence is crucial to efficacy.

“There clearly is an opportunity for us to work with specialty pharmacies to encapsulate some of those medications, probably in collaboration with the manufacturer and the health plan. It's going to take a collaboration of people here to figure out the value proposition around what an improvement in medication adherence is going to yield what the outcome is going to be, and how to build that into a value proposition,” Etectrx President and CEO Harry Travis told BioWorld. “There's also going to be plenty of opportunity to work with manufacturers. We anticipate manufacturers will want to see our encapsulated programs up and running as a first step to a longer-term commitment to the manufacturer side of the product.”

The ID-Cap is used to log, track and trend ingestion events and intake times; Etectrx will pursue an additional FDA clearance for medication adherence, much like Proteus also did initially. Any branded medications used in a drug-device combo also will require separate FDA approvals, much like Otsuka Pharmaceutical Co. Ltd. and Proteus did with their long road to an FDA approval for schizophrenia medication Abilify Mycite (aripiprazole tablets with sensor) that came in late 2017.

The ID-Cap system is classified as a class II medical device and an ingestible event marker. It will be available with a physician prescription and dispensed via a pharmacy.

The system is currently being used in a clinical trial at Brigham and Women's Hospital and Fenway Health in conjunction with the pre-exposure HIV prophylaxis (or PrEP) regimen using Truvada (emtricitabine/tenofovir disoproxil fumarate) from Foster City, Calif.-based Gilead Sciences Inc.

Another HIV study started recently at the University of Colorado at Denver to test the ID-Cap in combination with HIV treatment using a trio of drugs; it’s being backed by a grant from the NIH.

Travis anticipates that data demonstrating improved patient medication adherence and treatment outcomes will be crucial to advancing adoption of the technology. “There is a body of evidence on medication adherence on practically every therapy out there for example on diabetics or transplant patients. We have a certain sense of what the outcomes are with a medication inherently,” he said. “If we run a study and show that we can improve outcomes and we can improve medication adherence, we can monetize that.”

How it works

ID-Cap Reader. Credit: Etectrx Inc.

The system is comprised of empty, gelatin ID-Capsules that include the ingestible sensor ID-Tag, a lanyard-worn ID-Cap Reader, and related software. Once the capsule is ingested, it takes about five minutes for the reader to pick up the signal that will be emitted for about 20 to 30 minutes. The pendant can be placed around the neck with ingestion and then once it picks up the emitted signal it turns white and offers a thank you message to the patient. Then it can be removed until the next dosage is required.

“Our technology is both similar to and different from Proteus,” explained Travis. “We create a battery in your stomach; I always refer to the famous potato experiment that we all ran a high school where you can take a little bit of a positive and a negatively charged ionic material and get it into a solution where there's some free chloride ions and you get electron flow. We use magnesium and silver chloride on a very, very thin film of biocompatible plastic and our microchip is on that; Proteus uses magnesium and copper.”

“The difference after we generate our power is how we create the signal. They create what's called an electric conductive charge, which requires some physical medium to carry the charge, like a wire on your body,” he added. “Therefore, they need the patch because essentially their signal is a lot like the signal you get from an ECG lead listening to your heartbeat; you need skin contact to pick up that physiologic charge. Our microchip turns the energy into a very low power radio signal and radio waves go harmlessly through your body. So we get off body and we don't need a patch.”

The receiver could also assume different form factors in subsequent iterations of the technology. The back of a cell phone, the wristband of a fitness tracker or smartwatch or even a voice-controlled smart speaker could all potentially integrate a receiver. This could greatly improve convenience and usability for patients, as well as appeal to major potential partners.

The company was originally known as Etect and relied on angel investors who provided about $5 million. It has been around for more than a decade; in August 2016 it went through a controlled bankruptcy to form a new entity, recapitalizing it and changing the company name to Etectrx from Etect in the process. The startup has also received about $2 million in an NIH grant.

The startup plans to do a series A round this summer and in the meantime is putting together a bridge financing that’s expected to bring in an additional roughly $6 million to get there.

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