Celtic Pharmaceutical Holdings, the global private equity firm focused on the biotechnology and pharmaceutical industries, has announced the presentation of key in-vitro data at the American Academy of Dermatology (AAD) 69th annual meeting in New Orleans (4-8 February, 2011) for TDT 067, terbinafine in Transfersomesâ, for the topical treatment of onychomycosis (also known as a fungal nail infection).
The first of the two in-vitro studies presented by the lead investigator, Professor Mahmoud Ghannoum, Director of the Centre for Medical Mycology at Case Western Reserve University in Cleveland, Ohio, investigates the actvity of TDT 067 against the common causative agents of onychomycosis as measured by minimum inhibitory and fungicidal concentrations. The data demonstrate that TDT 067 has potent inhibitory and fungicidal activity against dermatophyte strains, and that the fungicidal activity of TDT 067 is shown to be more potent than conventional terbinafine preparations.
In a second in-vitro study, presented by Professor Ghannoum, the morphology and ultrastructure of dermatophyte hyphae were investigated following exposure to TDT 067 using scanning electron microscopy (SEM) and transmision electron microscopy (TEM). The data show that terbinafine formulated in Transfersomesâ in Celtic Pharma’s TDT 067 drug candidate potentiates the action of terbinafine by enabling it to penetrate more effectively to its site of action inside the fungus, where it disrupts the intracellular matrix leading to eventual death of hyphae.
Michael Earl, co-CEO of Celtic Pharma Development Services, says: “The in-vitro data presented at the AAD demonstrate that TDT 067 potentiates the anti-fungal effects of terbinafine and the entry of the drug into dermatophyte hyphae, which we believe will provide a significant clinical benefit for the treatment of onychomycosis. We hope to see confirmation of this benefit through the on-going pivotal clinical trial.”
TDT 067 is currently in Phase III development. A 42 centre global trial is currently in progress and has fully enrolled the planned 776 patients. The study is powered to provide registrational data on the efficacy, tolerability and safety of topically applied terbinafine delivered through the Transfersome targeted delivery technology over 48 weeks. Transfersomes are a trans-dermal drug delivery system that enables delivery of high concentrations of drug to deep tissue without significant systemic exposure to the drug, so TDT 067 is designed to obviate the hepatoxicity issues associated with oral administration of terbafine.
