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NIH grant 1R43AI197963-01: Provide a Set-It-And-Forget-it Copaxone Patch for Hourly Dosing of Medication to Combat Multiple Sclerosis.
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: Bruce Redding. Award: $320863.
Start: 2026-07-24T00:00:00.
PROJECT SUMMARY
Multiple Sclerosis (MS) is a chronic autoimmune disease with an increase of nearly 30% in global cases since
2013. The disease primarily affects adults aged 18-50 and is more prevalent in women than in men. MS is
characterized by inflammation, demyelination, gliosis, and neuronal loss and leads to vision impairment,
numbness and tingling, focal weakness, bladder and bowel dysfunction, and cognitive impairment. The
occurrence of MS significantly impacts patients’ quality of life by interfering with their daily activities due to fatigue,
pain and cognitive issues. The disease is managed by the administration of corticosteroids, plasma exchange,
and disease modifying therapies (DMTs). Glatiramer acetate (Copaxone) is one of the DMTs that is administered
via the subcutaneous route to reduce the number and severity of relapses. The subcutaneous delivery of the
drug presents significant challenges as it usually requires multiple doses and is associated with skin soreness,
redness, itch, or dimpling. Although standard passive skin patches are available to administer drugs through the
skin as an alternative to painful injections, these are largely limited in their functionality due to lack of control of
the flow rate of the drug, their dependence on low molecular weight skin absorption, and the contamination and
degradation of the drug molecules upon interaction with the adhesive on the patch. Transdermal Specialties has
developed the novel and specialised MS-1™ Patch that can be programmed to efficiently and non-invasively
deliver a prescribed amount of drug according to the treatment regimen of each MS patient. The “Set-It-And-
Forget-It” nature of this transdermal drug delivery system allows better patient compliance as the patient does
not need to recall the dosing regimen once they set the patch. Preliminary studies showed that the developed
solution can efficiently deliver Copaxone, in a Franz cell model, while maintaining the integrity and purity of the
drug, as observed through high-performance liquid chromatography (HPLC). This NIH SBIR Phase I aims to
optime the parameters of the patch for programming the safe delivery of Copaxone sufficient for a 24-hour period.
The study is expected to validate the optimal patch properties and parameters for ensuring the drug integrity,
drug release and shelf life of the patch before clinical validation. This achievement will pave the way for a SBIR
Phase II where the efficacy of the system in delivering Copaxone through the skin and reducing relapses in MS
patients will be demonstrated in human clinical trials.document fetched 2026-08-02 08:24