ATLANTA, GA, USA I November 29, 2017 I Aviragen Therapeutics, Inc. (NASDAQ:AVIR), a company focused on the discovery and development of direct-acting antivirals to treat infections that have limited therapeutic options, today announced the completion of patient enrollment in its Phase 2 CT4 clinical trial evaluating teslexivir (BTA074) for the treatment of condyloma. The Company expects to report top-line data from this trial in the second quarter of 2018.
“The enrollment and randomization of over 210 patients in the CT4 trial represents a significant milestone in the development of teslexivir,” said Joseph Patti, Ph.D., President and Chief Executive Officer of Aviragen. “We believe the direct-acting antiviral mechanism of action of teslexivir has the potential to both enhance clearance rates and reduce condyloma recurrence rates compared with currently approved treatments.”
CT4 is a Phase 2 double-blind, randomized, multi-center, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of teslexivir 5% gel in male and female patients with condyloma, or anogenital warts. Patients were randomized 2-to-1 (teslexivir to placebo gel) and dosed twice daily for up to 16 weeks. The primary efficacy endpoint is the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various efficacy assessments of clearance and wart area reduction for both baseline warts and post-baseline emergent warts, as well as the assessment of condyloma recurrence over a 3 month follow-up period, in patients who experience clearance.
Teslexivir is a topical antiviral agent that is a potent and selective inhibitor of the interaction between two essential viral proteins, E1 and E2, an interaction that is a necessary step for Human Papilloma Virus (HPV) 6 and 11 DNA replication and thus viral production. HPV types 6 and 11 are responsible for more than 90% of anogenital condyloma.
About Condyloma (Anogenital Warts)
Condyloma infections from HPV represent the most frequent viral sexually transmitted disease in adults worldwide. In the United States, approximately one to two percent of sexually active adults between the ages of 15 to 49 develop condyloma as the primary clinical manifestation of HPV infection. Currently available treatments for anogenital warts typically are divided into two categories, ablative/destructive therapies and topical therapies. Existing topical therapies are associated with significant mucosal toxicities manifesting as erosions and ulcerations, which can result in therapy discontinuation. Ablative options can be painful and scarring, and can lead to sexual dysfunction. Another significant limitation with current therapies is a high incidence of recurrence after successful primary treatment.
About Aviragen Therapeutics
Aviragen Therapeutics is focused on the discovery and development of the next generation of direct-acting antivirals to treat infections that have limited therapeutic options and affect a significant number of patients globally. It has three Phase 2 clinical stage compounds: BTA074 (teslexivir), an antiviral treatment for condyloma caused by human papillomavirus types 6 and 11; vapendavir, a capsid inhibitor for the prevention or treatment of rhinovirus upper respiratory infections; and BTA585 (enzaplatovir), a fusion protein inhibitor in development for the treatment of respiratory syncytial virus infections. Aviragen also receives royalties from marketed influenza products, Relenza® and Inavir®. Aviragen recently announced plans to merge with Vaxart, Inc., a privately-held clinical-stage company focused on developing oral recombinant vaccines from its proprietary delivery platform. For additional information, please visit www.aviragentherapeutics.com.
SOURCE: Aviragen Therapeutics
Post Views: 187
ATLANTA, GA, USA I November 29, 2017 I Aviragen Therapeutics, Inc. (NASDAQ:AVIR), a company focused on the discovery and development of direct-acting antivirals to treat infections that have limited therapeutic options, today announced the completion of patient enrollment in its Phase 2 CT4 clinical trial evaluating teslexivir (BTA074) for the treatment of condyloma. The Company expects to report top-line data from this trial in the second quarter of 2018.
“The enrollment and randomization of over 210 patients in the CT4 trial represents a significant milestone in the development of teslexivir,” said Joseph Patti, Ph.D., President and Chief Executive Officer of Aviragen. “We believe the direct-acting antiviral mechanism of action of teslexivir has the potential to both enhance clearance rates and reduce condyloma recurrence rates compared with currently approved treatments.”
CT4 is a Phase 2 double-blind, randomized, multi-center, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of teslexivir 5% gel in male and female patients with condyloma, or anogenital warts. Patients were randomized 2-to-1 (teslexivir to placebo gel) and dosed twice daily for up to 16 weeks. The primary efficacy endpoint is the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various efficacy assessments of clearance and wart area reduction for both baseline warts and post-baseline emergent warts, as well as the assessment of condyloma recurrence over a 3 month follow-up period, in patients who experience clearance.
Teslexivir is a topical antiviral agent that is a potent and selective inhibitor of the interaction between two essential viral proteins, E1 and E2, an interaction that is a necessary step for Human Papilloma Virus (HPV) 6 and 11 DNA replication and thus viral production. HPV types 6 and 11 are responsible for more than 90% of anogenital condyloma.
About Condyloma (Anogenital Warts)
Condyloma infections from HPV represent the most frequent viral sexually transmitted disease in adults worldwide. In the United States, approximately one to two percent of sexually active adults between the ages of 15 to 49 develop condyloma as the primary clinical manifestation of HPV infection. Currently available treatments for anogenital warts typically are divided into two categories, ablative/destructive therapies and topical therapies. Existing topical therapies are associated with significant mucosal toxicities manifesting as erosions and ulcerations, which can result in therapy discontinuation. Ablative options can be painful and scarring, and can lead to sexual dysfunction. Another significant limitation with current therapies is a high incidence of recurrence after successful primary treatment.
About Aviragen Therapeutics
Aviragen Therapeutics is focused on the discovery and development of the next generation of direct-acting antivirals to treat infections that have limited therapeutic options and affect a significant number of patients globally. It has three Phase 2 clinical stage compounds: BTA074 (teslexivir), an antiviral treatment for condyloma caused by human papillomavirus types 6 and 11; vapendavir, a capsid inhibitor for the prevention or treatment of rhinovirus upper respiratory infections; and BTA585 (enzaplatovir), a fusion protein inhibitor in development for the treatment of respiratory syncytial virus infections. Aviragen also receives royalties from marketed influenza products, Relenza® and Inavir®. Aviragen recently announced plans to merge with Vaxart, Inc., a privately-held clinical-stage company focused on developing oral recombinant vaccines from its proprietary delivery platform. For additional information, please visit www.aviragentherapeutics.com.
SOURCE: Aviragen Therapeutics
Post Views: 187
