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Adocia: positive phase 2 clinical results for the treatment of diabetic foot ulcer

25 May 2012

  • version française

Adocia, a biotechnology company based in Lyon (France), announced on 23th April 2012 positive results from its Phase II clinical trial evaluating the safety and efficacy of BioChaperone® combined with PDGF-BB for the treatment of diabetic foot ulcer. This product has been compared with Regranex®, a commercially available hydrogel of PDGF-BB (HealthPoint, initially launched by Johnson & Johnson).

Abstract

Adocia's spray formulation of PDGF-BB (Platelet Derived Growth factor), combined with BioChaperone®, has been evaluated versus Regranex®, gel of PDGF-BB recognized as the gold standard for diabetic foot ulcer treatment.

This clinical trial meets the main objectives with a dose reduction by three of the growth factor contained in Regranex® and a reduction of the frequency of application, once every two day versus every day for Regranex®.

This efficient, easy-to-use and cost-effective product could represent an important opportunity for the 10 million patients worldwide who are suffering from diabetic foot ulcers.

Adocia is planning a phase III clinical trial, in India, in the fourth quarter of 2012, in order to register its product in emerging countries in late 2014.

In the same time Adocia is actively preparing phase III clinical trials in the United States and Europe for the second half of 2013.

Phase 2 clinical trial for the treatment of diabetic foot ulcer

The multicentric trial has enrolled 192 patients in 4 groups consisting in the application of one of the three doses of BioChaperone PDGF-BB (14.5, 43.75 and 87.5 µg of PDGF-BB per cm2 and per week) and Regranex (43.5 µg per cm2 and per week), a commercially available hydrogel of PDGF-BB.

BioChaperone PDGF-BB treatments were administered once every two days whereas Regranex® was administered once a day, in compliance with the trial protocol that was approved by both US and European regulatory agencies.

The trial was not blinded due to the obvious difference in the medications, a spray for BioChaperone PDGF-BB and a gel for Regranex®. Treatments lasted 20 weeks or until complete healing.

The  objective of the study was to establish the non-inferiority of BioChaperone PDGF-BB compared to Regranex.

Analysis of negative side effects, collected through the intent-to-treat (ITT) population of 192 patients did not identify any serious side effect related to the treatment. These safety results indicate that BioChaperone PDGF-BB is well tolerated and safe at the three doses tested, for treatment periods up to 20 weeks.

The primary endpoint is the percentage of complete wound closure at 20 weeks. The rates of complete wound closure are all superior or equal to 66% after 20 weeks, therefore proving success on non-inferiority criteria for the three tested PDGF-BB doses.

One of the most promising results is the 80% rate of complete wound closure at 20 weeks obtained with the dose of BioChaperone containing one-third of the Regranex® equivalent of PDGF-BB dose and with only one application every two days.

For the three tested doses, secondary efficacy endpoints, i.e.

  • the percentage of complete wound closure at 10 weeks,
  • the time to achieve complete wound closure (expressed by Kaplan-Meier median) and
  • the percentage of reduction in wound area

are all considered as non-inferior compared to Regranex.

These clinical results will be presented in major scientific congresses on wound healing,

  • at the European Wound Management Association in Vienna, Austria,  on May 23-25, 2012 and
  • at the World Union of Wound Healing Societies in Yokohama, Japan on September 2-6, 2012.

Statements about phase 2 clinical trial for the treatment of diabetic foot ulcer

Statement by the principal investigator of the study

Dr. Arun Bal (Mumbai), principal investigator of the study said: "We were very pleased to conduct this clinical study on this attracting product which showed undisputed efficacy. The simplicity of use of the spray as well as the frequency of application once every two days had a very positive impact on patient compliance and was very well received among patients".

Statement by the Chairman and CEO of Adocia

"The results obtained with  one-third of the dose of PDGF-BB with the BioChaperone PDGF-BB spray  pave the way for a cost-effective treatment in this disease affecting 10 million people worldwide. Cost of treatment is a key issue not only in emerging countries but also in the western countries" declared Dr. Gérard Soula, Chairman & CEO of Adocia.

Statement by the R&D director of Adocia

"We are now actively preparing a phase III trial which could be launched in the fourth quarter of 2012 in India and two phase III clinical trials in the United States and in Europe planned for the second half of 2013. The Indian study should be the last step before marketing the product in emerging countries", noted Dr. Olivier Soula, R&D director of Adocia.

About diabetic foot ulcer

15% of diabetic patients will develop a diabetic foot ulcer in their lifetime. Diabetic foot ulcer is a major and increasing public-health problem.

Foot ulcers cause substantial morbidity and are a leading cause of amputations. The number of amputations per year, worldwide, due to diabetes is estimated at over one million.

Moreover, diabetic foot ulcer multiplies by 2.4 the risk of death of the patient.

Find out more

Adocia is a biotechnology company specialized in the development of best-in-class medicines with already approved therapeutic proteins. Adocia is based in Lyon (France) and is a member of Lyonbiopôle competitiveness cluster.

Adocia is specialized in insulin therapy and the treatment of the diabetic foot ulcer, one of the main complications of diabetes.

Through its BioChaperone state-of-the-art technological platform, Adocia enhances the effectiveness and safety of therapeutic proteins and their ease of use for patients, with the aim of making these medicines accessible to the broadest public.

Based on its experience and recognised know-how, Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold standard molecules for the treatment of numerous chronic pathologies (oncology, inflammation, etc.). In this field, Adocia is engaged in collaborative programs with two major pharmaceutical companies.

Adocia's therapeutic innovations aim at bringing solutions to a profoundly changing global pharmaceutical and economic context, characterised in particular by the increased prevalence and impact of the targeted pathologies, population growth and ageing, the need to control public health expenditures and increasing demand from emerging countries.