Adocia reports positive phase II clinical results for the treatment of diabetic foot ulcer
Adocia’s spray formulation of PDGF-BB (Platelet Derived Growth factor), combined with BioChaperone(R), has been evaluated versus Regranex(R), gel of PDGF-BB, the only available treatment 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(R) and a reduction of the frequency of application, once every two day versus every day for Regranex(R)
This efficient, easy-to-use and cost-effective product could represent an important opportunity for the ten 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. At the same time Adocia is actively preparing phase III clinical trials in the United States and Europe for the second half of 2013
Lyon, April 23, 2012 – Adocia (NYSE Euronext Paris: FR0011184241 - ADOC), a biotechnology company specialized in the development of best-in-class medicines with already approved therapeutic proteins, announces today positive results from its Phase II clinical trial evaluating the safety and efficacy of BioChaperone(R) combined with PDGF-BB for the treatment of diabetic foot ulcer. This product has been compared with Regranex(R), a commercially available hydrogel of PDGF-BB (HealthPoint, initially launched by Johnson & Johnson).
The multicentric trial has enrolled 192 patients in four groups
consisting in the application of one of the three doses of
BioChaperone PDGF-BB (14.5, 43.75 and 87.5 micrograms of PDGF-BB
per square cm and per week) and Regranex(R) (43.5 micrograms per
square cm and per week). BioChaperone PDGF-BB treatments were
administered once every two days whereas Regranex(R) 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(R).
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(R).
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 was the percentage of complete wound closure
at 20 weeks. The rates of complete wound closure are all superior
or equal to 66 per cent 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 per cent rate of complete wound closure at 20 weeks obtained with the dose of BioChaperone containing one-third of the Regranex(R) 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 ten 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(R).
“We were very pleased to conduct this clinical study on this attractive product which showed undisputed efficacy,” said Dr. Arun Bal (Mumbai), principal investigator of the study. “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.”
“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 ten million people worldwide,” said Dr Gérard Soula, chairman & CEO of Adocia. “Cost of treatment is a key issue not only in emerging countries but also in the western countries.”
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.
“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,” said Dr Olivier Soula,
VP R&D director of Adocia. “The Indian study should be
the last step before marketing the product in emerging
countries.”
About BioChaperone PDGF-BB
BioChaperone PDGF-BB is a topical aqueous sterile formulation
administered via a multidose spray device. Comparison of
theoretical treatment dosing and dose effectively delivered from
the container in the four treatment groups suggested a very good
compliance to study medication for BioChaperone PDGF-BB doses,
whereas large discrepancies between theoretical and used amounts of
Regranex(R) gel were observed. BioChaperone PDGF-BB is a
formulation comprising PDGF-BB and one polymer of the proprietary
BioChaperone(R) platform. Adocia specifically designed this polymer
to form a molecular complex with PDGF-BB to protect it from
enzymatic degradation. This protection sustains the efficacy of
PDGF-BB and permits the reduction of the frequency of application
by two and even the reduction of the dose by three. BioChaperone
also stabilizes PDGF-BB in the vial at neutral pH for three months
at room temperature. The spray device guarantees the sterility of
the solution after multiple uses. This property permits to avoid
the usage of antibacterial agents which are deleterious for cell
proliferation.
About Diabetic Foot Ulcer
15 per cent 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.
About Adocia
“Innovative medicine for everyone, everywhere”
Adocia is a biotechnology company specialized in the development of
best-in-class medicines with already approved therapeutic proteins.
Adocia is specialized in insulin therapy and the treatment of the
diabetic foot ulcer, one of the main complications of diabetes.
Worldwide, more than 366 million individuals are currently
suffering from diabetes (with a forecast of 552 million individuals
by 2030, i.e. a 51 per cent increase, reaching 70 per cent in
emerging countries). 15 per cent of these patients will develop a
foot ulcer during their lifetime. The markets targeted by ADOCIA
represent more than USD 20 billion (USD 17 billion for insulin
therapy and USD three billion for diabetic foot ulcer healing).
Through its BioChaperone(R) 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.
Adocia successfully completed two phases I and II studies on the
formulation of a fast-acting human insulin and obtained promising
phase I/II results on a diabetic foot ulcer healing product. Adocia
also confirmed the value of its technology for the formulation of a
fast-acting insulin analog by signing an exclusive worldwide
license agreement with a major pharmaceutical company. Furthermore,
Adocia is developing a unique combination of fast-acting insulin
and slow-acting insulin, for an optimal insulin therapy with one
single product.
To be a global leader for the formulation of therapeutic
proteins
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. Adocia is listed on the regulated market of NYSE
Euronext in Paris (ISIN Code: FR0011184241, mnemonic code / Reuters
/ Bloomberg: ADOC, ADOC.PA, ADOC.FP), and its share is included in
the Next Biotech index.
For more information: http://www.adocia.com
Disclaimer
This press release contains certain forward-looking statements
concerning ADOCIA and its business. Such forward-looking statements
are based on assumptions that ADOCIA considers to be reasonable.
However, there can be no assurance that the estimates contained in
such forward-looking statements will be verified, which estimates
are subject to numerous risks including the risks set forth in the
“Risk Factors” sections of the prospectus registered by
the Autorité des marchés financiers on January 25,
2012 under number 12-034 (a copy of which is available on
www.adocia.com) and to the development of economic conditions,
financial markets and the markets in which ADOCIA operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to ADOCIA or not currently
considered material by ADOCIA. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of ADOCIA to be materially different
from such forward-looking statements.
This press release and the information that it contain do not
constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, ADOCIA shares in any
country.
For further information, please contact:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
allo@ala.com / neil@ala.com
Posted: April 2012