Paris, October 31, 2013. Anaconda Pharma today announced the positive outcome of the Phase IIa trial of its novel, first-in-class therapeutic AP611074 against condyloma (ano-genital warts). Condyloma is caused by human papillomavirus subtypes 6 and 11 and is one of the world`s most frequent sexually transmitted diseases with millions of new cases each year and no fully satisfactory treatment.
Anaconda’s double-blind, placebo-controlled, phase IIa randomized clinical trial showed that AP611074 is safe and effective in removing or reducing ano-genital warts when applied as a topical gel over 6 weeks of treatment. The study demonstrated that AP611074 has an excellent safety profile resulting in high patient compliance, no patient drop-outs or treatment interruptions - in stark contrast to clinical trial data published for existing drug treatments. The detailed results of the trial will be presented at the upcoming conference of the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) in Florence (Italy) from November 3 to 6 2013.
Marta Blumenfeld, Ph.D., President and Chief Executive Officer of Anaconda Pharma commented: “AP611074 is a scientific breakthrough as it is the first compound in clinical development that directly tackles HPV and prevents the replication of the virus in infected cells. Furthermore, AP611074 is a small molecule drug inhibiting a protein-protein interaction (PPI). Inhibiting PPI is a mode of action with large therapeutic potential which has been frustratingly difficult to address with small chemical molecules.”
“The safety profile of AP611074 looks excellent and was consistent with pre-clinical studies. No relevant side effects, as well as a very low incidence of skin side effects, occurred during the phase IIa trial nor in the two phase I studies, which is a great potential advantage compared to existing therapies”, commented Prof. Olivier Chosidow, M.D., Ph.D., Chairman of the Department of Dermatology at Hospital Henri Mondor, Créteil, France, and Investigator Coordinator of the clinical study.
Anaconda Pharma fully owns a granted matter-of-substance patent for the lead compound (AP611074) and related compounds, and patent applications for its synthesis and formulation.
Large unmet medical need
Ano-genital warts represent a substantial medical need, with several million patients affected each year: global prevalence in the sexually active population amounts to about 1% (higher in emerging markets). While not life-threatening or debilitating, condyloma is mostly perceived by affected individuals as a disfiguring and shameful condition, causing anxiety and severe social and psychological stress. In most cases, patients experience early onset (adolescence/young adults) and frequent relapses during their entire life. Immunosuppressed persons (HIV patients, post-transplantation patients) frequently suffer from condyloma.
Potential additional application against orphan indication RRP
AP611074 could also potentially be utilized to address Recurrent Respiratory Papillomatosis (RRP) – an orphan indication that affects between 1 and 7 persons in 100’000 (both infants and adults), with costs per patient of up to USD 470’000. AP611074 can also be formulated for oral delivery, e.g. to address RRP or to treat cases of widespread condyloma (e.g. for immunosuppressed persons). Furthermore, the company’s proprietary discovery knowhow could also be applied to search for inhibitors of other HPV subtypes, notably those causing skin warts or cervical cancer.
About Anaconda Pharma
Anaconda Pharma was founded in 2003 as a spin-out of the Institut Pasteur and is focused on the development of treatments against infections by Human Papillomavirus (HPV). Anaconda’s scientific co-founders are affiliated with Institut Pasteur (Paris, France) and UC Berkeley (USA) and include some of the leading scientists in the field of HPV and related diseases. www.anacondapharma.com
Anaconda Pharma Contact
Marta Blumenfel
d President and CEO
Villejuif Biopark
1 mail du Prof. Georges Mathé
94800 Villejuif
France
Tel+33(0)1 82 28 73 02
mblumenfeld@anacondapharma.com
www.anacondapharma.com
Anaconda Pharma Media Contact
IRF Communications
Daniel Piller, Partner
Rämistrasse 4
8024 Zürich
Switzerland
Tel +41 43 244 81 54
daniel.piller@irfcom.ch
www.irfcom.ch
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