BioChaperone PDGF spray for diabetic foot ulcers

NewsBot · Mar 21, 2013

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Press Release:
Adocia announces its phase III development program for the treatment of diabetic foot ulcer

Adocia (NYSE Euronext Paris: FR0011184241 - ADOC), a biotechnology company specialized in the development of 'best-in-class' medicines from already approved therapeutic proteins announces today the phase III development program of its product, BioChaperone(R) PDGF-BB for the treatment of diabetic foot ulcer (DFU). The European Medicines Agency (EMA) issued positive scientific advice for this program.

Adocia has developed a unique formulation, a BioChaperone PDGF spray for the treatment of DFU. Based on the positive results of the phase II clinical trial in India, Adocia has filed a dossier for a phase III clinical trial there. This dossier is currently under review by the DCGI (Drugs Controller General of India). The trial should permit Adocia to file a request for marketing authorization in India and other emerging countries.

Adocia is also actively preparing a clinical program for marketing the product in Europe and the United States of America.

In Europe, Adocia is focusing on the treatment of neuroischemic DFU which is the most frequent form of the disease; affecting 60 per cent of patients. It is the most difficult to heal with a high rate of amputation. There is currently no approved treatment for neuroischemic DFU. There is a medical need for this indication which should facilitate the regulatory approval of a treatment for the disease. In order to validate the regulatory pathway for the Marketing Authorization Application (MAA) Adocia has asked for scientific advice from the EMA.

The EMA agrees that only one phase III study conducted in Europe would be required for the MAA. In addition, the clinical data from the phase III trial in India would be admissible to the MAA.

The EMA advice also included agreement on the design and protocol features of the Phase III trial. The pivotal phase III clinical trial in Europe is designed to assess the efficacy of BioChaperone PDGF-BB compared to a placebo for the treatment of neuroischemic DFU. The trial is expected to be launched in mid 2014.

"This scientific advice from the EMA which validates our clinical program in Europe is an important milestone. We are now preparing the submission of the clinical development plan for the FDA in the USA," said Olivier Soula, director of R&D and deputy general manager, Adocia.

"This positive advice was critical in order to move forward in our discussions with potential partners as it helps to define budget and milestones until commercialization," said Gerard Soula, president & CEO of Adocia.
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NewsBot · Jan 13, 2014

Press Release:
Adocia Strengthens Its Diabetic Foot Ulcer Patent Portfolio

Adocia, a biotechnology company specializing in the development of 'best-in-class' medicines from already approved therapeutic molecules, in particular proteins and oncologic drugs, announces today that it has been granted two patents. The first patent is granted in Japan for the BioChaperone PDGF composition and the second in the United States for the BioChaperone polymers. Both patents will protect Adocia's findings in the field of chronic wound healing, especially for diabetic foot ulcers.

The BioChaperone PDGF product has been successfully tested in a phase II clinical trial in India for the treatment of diabetic foot ulcers. This product is protected by two families of patents. The first one covers the complexes between the BioChaperone polymers and PDGF; the second covers the BioChaperone polymers as such.

The patent on the complexes was granted in Europe and the United States in 2012 (cf. press release of June 13, 2012). The inclusion of Japan now extends the coverage to 29 countries. Twenty-three are in Europe and the rest are the United States, Australia, Mexico, Russia and South Africa. This patent confers a protection until September 26, 2026.

The BioChaperone polymers, a proprietary technology specifically developed by Adocia, are covered by the other patent. This patent has just been granted by the US Patent and Trademark Office (USPTO). The protection of these BioChaperone polymers is now established in the United States, Australia, China, Russia, France and South Africa. It is valid until September 26, 2027.

"We are very pleased by these positive decisions on two of our strategic patent families, especially because they have been granted by the very demanding national United States and Japanese patent offices. Our product for the treatment of diabetic foot ulcer is patent protected until at least 2026," said Remi Soula, director of business development and intellectual property at Adocia. "The granting of these patents consolidates our 22 families strong patent portfolio. For six of these families, the US patent has already been delivered."

"We are actively pursuing the clinical development of the BioChaperone PDGF product for the treatment of diabetic foot ulcer. These patents cover the major markets we are targeting. Moreover, we hope to receive authorization to launch the phase III clinical trial in India very soon", said Olivier Soula, delegate general director and R&D director.
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NewsBot · Aug 26, 2014

Press Release:
Study aims to support marketing approval of BioChaperone PDGF-BB in India and other emerging countries

Adocia announced today the initiation of a clinical Phase III study in India of BioChaperone(R) PDGF-BB, the Company's innovative formulation of Platelet Derived Growth Factor (PDGF-BB) for the treatment of diabetic foot ulcers. This follows the approval given by the Drug Controller General of India (DCGI) on August 22(nd) , 2014. The dossier for this clinical trial was filed in September 2012, but the processing of the application had been delayed by the internal reorganization of the Indian regulatory agency.

This Phase III clinical trial is designed to confirm on a large population the efficacy of BioChaperone PDGF-BB spray to treat diabetic foot ulcer. Its results are expected to be used to support registration and market approval in India and in several other emerging countries. This double-blind, multicenter study will enroll 252 diabetic patients with a chronic foot ulcer. The main efficacy endpoint is complete wound closure after a maximum 20 weeks of treatment. Secondary efficacy criteria include wound closure at 10 weeks and the rate of reoccurrence three months after closure. Results of this study are expected in the first quarter 2016.

Olivier Soula, General Deputy Manager and Director of R&D at Adocia stated, "We are very pleased to have obtained the Indian Agency's approval to begin this clinical study, which, should it be successful, would support marketing approval of Adocia's product in India as well as in several other emerging countries. In keeping with the European Medicine Agency's validation of our clinical pathway, the results of this study would be supportive to our European dossier, and only one Phase III clinical study in Europe would be required. Accordingly, we also continue preparing our clinical dossier for a European Phase III study."

Diabetic foot ulcer is a severe complication of diabetes. These ulcers are chronic wounds, for which secondary infection can lead to amputation. Treatment options remain limited and in many countries the only approved biological product to treat this disease is Regranex(R) (Smith & Nephew, gel of PDGF-BB for topical application). In a previous Phase II clinical trial, Adocia's BioChaperone PDGF-BB spray formulation showed a wound closure efficacy at least equivalent to Regranex's efficacy, at one-third the weekly dosage and when applied half as often. The wounds healed with BioChaperone PDGF-BB also showed a lower risk of reoccurrence, which should limit the risk of amputation. The reduced frequency of application with BioChaperone PDGF-BB should also reduce the cost of care, by minimizing hospital and other costs (dressings, etc.). The three-time reduction of the weekly dose of product should also lower the total cost of treatment.

"Diabetic foot ulcer affects millions of patients throughout the world. We are convinced that BioChaperone PDGF-BB could be a breakthrough for these patients by offering a more effective and affordable treatment," stated Gérard Soula, CEO of Adocia. "In line with our dual strategy for gaining approval in western and emerging countries, we made the strategic decision to develop this innovative treatment first in India, where the diabetic population has reached 65 million and where the PDGF-BB therapeutic protein is already approved."
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NewsBot · Sep 11, 2014

This clinical trial was just registered:
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).
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NewsBot · Aug 27, 2016

Diabetic Foot Ulcer Spray Fails Phase 3 Test
BioChaperone PDGF is equivalent to placebo

Adocia scraps diabetic foot ulcer program following PhIII flop

Press Release:
Adocia announces topline results of Indian Phase 3 trial of
BioChaperone PDGF for diabetic foot ulcer
 BC PDGF did not meet the primary endpoint in this Phase 3 trial conducted in
India
 BC PDGF was confirmed to be safe and well tolerated

Lyon, August 25 2016 - Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage
biopharmaceutical company focused on the treatment of diabetes with innovative formulations
of approved proteins, today announced topline results from a Phase 3 clinical trial of
BioChaperone PDGF (BC PDGF) in the treatment of diabetic foot ulcer (DFU), which was
conducted in India.
In this trial, BC PDGF did not meet the primary endpoint of a statistically significant
improvement over placebo in complete wound closure after twenty weeks of treatment. There
were no safety concerns attributed to BC PDGF.
“We are surprised and disappointed by these topline results, which are inconsistent with
previously reported positive Phase 1/2 clinical results. Therefore, we have initiated a thorough
review of the study to analyse the discrepancy in the data” said G?rard Soula, CEO of Adocia.
“However, diabetic foot ulcer has proved an extremely difficult condition to address, as seen
in multiple recent late-stage clinical trial failures. The main reason is the lack of uniformity in
the standard of care of these types of wounds. In this context, we have decided to halt all
development work in this indication. As announced previously, we are focusing our efforts on
our portfolio of innovative injectable therapeutics for the treatment of diabetes.”
This randomized, double-blind, multicenter, outpatient study enrolled 252 diabetic patients
from India with a chronic DFU. In addition to standard of care, each group of patients was
treated every two days for a maximum of 20 weeks with either a placebo spray (saline
solution) or a spray containing BC PDGF.
Adocia would like to thank all participating patients and trial investigators for their
commitment.
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BioChaperone PDGF spray for diabetic foot ulcers

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BioChaperone PDGF spray for diabetic foot ulcers

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