The clinical trial treated patients for 12 weeks with a primary endpoint of mycological cure at 14 weeks and follow up to 48 weeks. A 90% negative mycological cure rate (as defined by negative culture and KOH microscopy) was observed at 14 weeks, and at 48 weeks the mycological cure rate was still 38% despite no active treatment for the preceding 36 weeks. TDT-067 was well tolerated with negligible systemic drug exposure (no patient had more than 2ng/ml of terbinafine at steady state and the large majority of the patients had no detectable levels, i.e. below 1 ng/ml).
Commenting on the trial, John Mayo and Stephen Evans Freke said: “Combining these results with the clear nail growth achieved, we believe that we have a product candidate that not only exceeds existing topical treatments in terms of efficacy, but may be comparable to systemically delivered products. Moreover, we saw in the study that TDT-067 was well tolerated with negligible signs of systemic exposure and no serious local side effects, which will allow us to treat patients for longer which should improve efficacy further.”
The trial explored the efficacy and safety of topically applied terbinafine delivered through the Transfersome® targeted delivery technology. Celtic Pharma acquired an exclusive global licence to IDEA AG’s Transfersome® technology in February 2006.
Onychomycosis is a fungal infection of the fingernails and toenails that results in thickening, discoloration, and splitting of the nails and lifting of the nail from the nail bed. The disease has a high incidence within the general population, especially among older individuals. Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes.
Innovative drug carriers called Transfersomes® have been developed for the non invasive delivery of agents into or through the skin. Transfersome® preparations consist of complex lipid vesicles, which are able to cross the skin permeability barrier, the stratum corneum, driven by the transcutaneous water gradient. TDT-067 (terbinafine in Transfersomes®) is a novel, epicutaneously applied carrier-based dosage form of terbinafine in development for the treatment of onychomycosis of the toenail and fingernail.
About Celtic Pharmaceutical Holdings L.P.
Celtic Pharmaceutical Holdings L.P. is a global private equity investment firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programmes and drives these programmes through the final stages of regulatory approval. Celtic Pharma’s aim is to bridge the gap between the established pharmaceutical companies’ new product pipeline crisis and the biotech industry’s capital drought. For further information, please visit Celtic Pharma’s website at www.celticpharma.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Celtic Pharma disclaims any intent or obligation to update these forward-looking statements.
