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Ferrer Submits IND for Arasertaconazole Nitrate

Published: Tuesday, January 01, 2013
Last Updated: Monday, December 31, 2012
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Phase III studies in VVC for the patented, best-in-class topical azole will be initiated at the beginning of 2013, subject to regulatory approval.

Ferrer has announced that it has filed an IND for its topical antifungal agent Arasertaconazole nitrate.

The agent has recently demonstrated rapid symptomatic relief and significant clinical and mycological benefits after a single administration delivered as a vaginal suppository (pessary) formulation in a multicentre Phase II study in patients with VulvoVaginal Candidiasis (VVC).

VVC, or vaginal thrush as it is also known, is a common infection affecting 70 - 75 per cent of women at least once in their lives. The worldwide market for gynaecological antifungal products exceeds USD 600 million per annum.

Arasertaconazole is a new, fast-acting topical antifungal. The agent has a broad spectrum of activity against Candida spp involved in VVC, including species described as resistant to fluconazole.

It is the active, patented, R-enantiomer of sertaconazole nitrate, itself an antifungal agent developed by Ferrer and marketed for more than 20 years in more than 70 countries.

Formulated as a vaginal suppository (pessary), Arasertaconazole has demonstrated very low systemic exposure, a good safety profile and was well tolerated in clinical studies involving 283 female subjects to date.

In the multicentre Phase II dose-ranging study involving 229 female patients with VVC, Arasertaconazole formulated as a vaginal suppository (pessary) demonstrated both fast-acting (superiority to placebo at 8 plus/minus 2 days of treatment) and prolonged (up to at least 26 plus/minus 4 days) clinical and mycological efficacy at all doses tested (150mg, 300mg, 600mg).

The therapeutic response to Arasertaconazole was dose-dependent, with the 600mg dose most efficacious.

Moreover, Arasertaconazole showed evidence of rapid relief from additional clinical symptoms (at less than 2 days, e.g. irritation and itching) when compared to placebo. Arasertaconazole was both safe and well tolerated in this study.

"VulvoVaginal Candidiasis (VVC) due to Candida spp infections remains a common problem worldwide, especially in women of childbearing age. The emergence of both treatment resistant Candida species and new pathogenic strains are considered some of the reasons for the underserved medical needs in this condition," said Antonio Guglietta, R&D Director at Ferrer.

Guglietta continued, "Following discussions with the regulators, Ferrer will initiate Phase III clinical studies that will further differentiate Arasertaconazole as a safer, fast-acting antifungal treatment for VVC in women aged more than 12 years old."

Ferrer is currently assessing alternative formulations for Arasertaconazole as treatments for other topical fungal infections that include tinea pedis (athlete's foot).

Arasertaconazole, as well as the vaginal suppository (pessary) formulation, is the subject of granted and pending patent applications and is available for further development and commercialization worldwide from Ferrer.

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