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London, UK – 16 November 2016: Ergomed plc (LSE: ERGO) (‘Ergomed’ or ‘the Company’), a clinical trial services and drug development company, is pleased to note that its co-development partner Modus Therapeutics Holding AB has announced that following a planned safety review by an independent Data Safety Monitoring Board, adolescents between the ages of 12 and 18 can now be enrolled in its ongoing Phase II clinical study with sevuprin in Sickle Cell Disease. In addition, the Company has decided to expand the study sample size to 150 patients in total with top line results now expected in H1 2018 rather than in H1 2017.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:
“The decision to expand our joint Phase II clinical study with Modus Therapeutics will strengthen the study and resulting data. Broadening the inclusion criteria from adults to include adolescents with Sickle Cell Disease will allow us to fully explore the clinical potential of sevuparin to support a pivotal Phase III study in this indication. We look forward to reporting the data in the first half of 2018.”
The full text of the announcement from Modus Therapeutics is as follows:
Modus Therapeutics – Independent Data Safety Monitoring Board endorses inclusion of adolescents in ongoing clinical study with sevuparin in Sickle Cell Disease
STOCKHOLM – November 15, 2016. Modus Therapeutics AB today announced that after a safety review by an independent Data Safety Monitoring Board, adolescents between the age of 12 and 18 will now be enrolled into its ongoing clinical study with sevuparin in Sickle Cell Disease (SCD). In addition, the Company has decided to increase the sample size of the current Phase II study to around 150 patients in total, so that this study can play a more important role in the overall clinical program needed to register sevuparin.
A planned independent Data Safety Monitoring Board (DSMB) review has been conducted in the multi-centre, randomized Phase II clinical study currently recruiting SCD patients in Europe and Middle East. In accordance with the study protocol, the first 25 SCD patients that were treated were adults in order to establish sevuparin’s safety. The independent DSMB has now reviewed all safety and pharmacokinetic data for these first 25 adult patients. The recommendation from the DSMB is to continue the study as planned and to extend the inclusion criteria to allow the recruitment of adolescents between the ages of 12 and 18 years.
The ongoing Phase II study is designed to demonstrate a reduced time to resolution of Vaso-Occlusive Crises (VOC) in hospitalized SCD patients treated with sevuparin in comparison to those treated with placebo. The study is targeting a potential 30% reduction in the time to resolution of the VOC, which would make a significant difference to the SCD patients as well as for healthcare providers. This anticipated reduction is based on an analysis of the clinical data with Low-Molecular-Weight heparin that is available in the literature.
Modus Therapeutics decided prior to the DSMB review to remove the sample size re-calculation originally planned after 45 randomized patients (a. k. a. the interim analysis) and instead aim for a total of 120 evaluable VOC resolutions. This would require the study to enrol about 150 patients. This amendment will allow the Company to fully explore the clinical potential of sevuparin to support a pivotal Phase III study. The top-line phase II data is now expected in H1 2018.
Commenting on today’s announcement, Christina Herder, CEO of Modus Therapeutics, said: “This positive recommendation by the DSMB is an important milestone for our clinical Phase II study as it will allow us to include adolescents with SCD. As with adults, they are also in need of new treatments which are effective in resolving the severe and devastating VOCs, which cause them extreme pain and increase their risk of long-term complications including organ damage and premature death.”
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|Ergomed plc||Tel: +44 (0) 1483 503205|
|Miroslav Reljanovic (Chief Executive Officer)|
|Stephen Stamp (Chief Financial Officer)|
|Numis Securities Limited||Tel: +44 (0) 20 7260 1000|
|Michael Meade / Freddie Barnfield (Nominated Adviser)|
|James Black (Joint Broker)|
|Stifel Nicolaus Europe Limited||Tel: +44 (0) 20 7710 7600|
|Jonathan Senior (Joint Broker)|
|FTI Consulting – for UK enquiries||Tel: +44 (0) 20 3727 1000|
|Simon Conway / Mo Noonan|
|MC Services AG – for Continental European enquiries||Tel: +49 (0) 211 52925222|
Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: http://ergomedplc.com.
About Modus Therapeutics
Modus Therapeutics is a clinical-stage drug development company developing new pharmaceutical therapies designed to restore impaired blood flow and oxygen transport in rare diseases with large unmet medical need. The Company’s most advanced candidate, sevuparin, is currently being evaluated in a Phase II clinical trial in sickle cell disease (SCD). Repeated painful crises in SCD, so called vaso-occlusive crises (“VOC”), leads to loss of vital organ function and often significantly reduced life span.
Modus Therapeutics is based in Stockholm. The Company’s major shareholders are KDev Investments AB (an investment fund jointly owned by Karolinska Development AB and Rosetta Capital), Östersjöstiftelsen (The Foundation for Baltic and East European Studies), and Praktikerinvest PE AB. For more information, please visit www.modustx.com