Corium’s MicroCor® system utilizes dissolving microstructures (microneedles) for innovative, needle-free delivery of biologics across the skin.
This technology can also be combined with small molecules, when rapid onset of action is desired.
Our investigational MicroCor PTH(1-34) product candidate contains the active ingredient in Eli Lilly’s Forteo® (teriparatide [rDNA origin] injection), which is approved for the treatment of osteoporosis. Forteo requires a daily self-administered injection and sharps (needle) disposal, and is required to be kept refrigerated. MicroCor PTH(1-34) has successfully completed Phase 2a clinical evaluation. We have also demonstrated the ability to incorporate a wide range of molecules into the MicroCor system, from small molecules to peptides, proteins, monoclonal antibodies and vaccines.
In MicroCor drug-in-tip technology we blend active therapeutic agents with proprietary polymer and excipient combinations to create arrays of solid-state biodegradable microstructures. These arrays are designed specifically to optimize the delivery of therapeutic or prophylactic agents either locally or systemically. MicroCor arrays penetrate the superficial layers of the skin, dissolving or biodegrading upon application. Traditional injections are associated with bleeding and discomfort, which can be reduced or eliminated using MicroCor.
Additional benefits include:
- Single step administration
- Short (<5 minutes) wear time
- No needles or sharps
- No need for refrigeration, simplifying handling and storage; and
- Ability to customize the pharmacokinetic profile, allowing for immediate or sustained release.
Moreover, by delivering vaccines to the upper layers of the skin, which are rich in antigen-presenting cells, MicroCor has the potential to provide a more robust and consistent immune response. In some cases, this may enable us to design a vaccine that could allow dose sparing and/or the avoidance of adjuvants.
Corium has established GMP manufacturing facilities, quality systems for scale-up, and cost-effective manufacturing processes to support early-stage through clinical development programs.
Microstructures Enable Transdermal Delivery of A Wide Range of Molecular Weights
Microstructures are comprised of 2 layers; a dissolving drug-in-tip layer (in orange) and a water insoluble backing layer (in blue).
Upon application to the skin, the microstructures, which are few hundred μm in length, penetrate into the outer layers of the skin. The moisture in the skin rapidly hydrates the drug-in-tip layer.
Within 5 minutes, the drug-in-tip layer is dissolved and the active agent rapidly diffuses into blood vessels in the dermal layer. The water insoluble backing layer is removed.
The safety and efficacy of MicroCor PTH(1-34) and other MicroCor-based products have not been established. There is no assurance that any of these investigational products will receive health authority approval or become commercially available in any country.