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Phase III washout for Adocia
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Clinical TrialsFrance

Phase III washout for Adocia

26.08.2016 - Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.

Adocia announced the topline results for its Phase III trial of diabetic foot ulcer treatment BioChaperone PDGF. The product did not meet the primary endpoint in this Phase III trial conducted in India, the Lyon-based company said. CEO Gérard Soula did not hold back his consternation: “We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase 1/2 clinical results.”

The randomised, double-blind, multicentre, outpatient study enrolled 252 diabetic patients from India with a chronic diabetic foot ulcer. 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. However, after this time, BC PDGF did not perform better than the placebo and therefore did not meet the primary endpoint.

Now, Adocia has decided to stop development in this indication, focusing instead on injectable therapeutics for the treatment of diabetes. “Diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late-stage clinical trial failures,” stressed Soula. “The main reason is the lack of uniformity in the standard of care of these types of wounds.”

The company’s stock price, which had lately reacted favourably to the publication of the financial results, took a hit. Share prices fell by almost 20 percent.


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http://www.european-biotechnology-news.com/news/news/2016-03/phase-iii-washout-for-adocia.html

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

ApprovalEU

04.08.2016 After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to “explore the concept further” and will continue to accept proposals.

© 2007-2016 BIOCOM

http://www.european-biotechnology-news.com/news/news/pos/1.html

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No liability assumed, Date: 25.08.2016