EMA grants orphan status to Synovo anti-inflammatory for Cystic Fibrosis
JULY 07, 2014
Press Release | Synovo GmbH
Tuebingen, Germany: – German-based pharmaceutical discovery company Synovo GmbH today announced that the European Medicines Agency (EMA) has granted its anti-inflammatory drug with orphan (rare disease) status as a treatment for Cystic Fibrosis. Synovo refers to its candidate as CSY0073.
CSY0073 has been adjudged to provide an alternative to anti-inflammatory therapies that are also anti-bacterial, thus potentially contributing to a reduction in selection for antibiotic resistance. The drug is a novel compound that reduces inflammation and prevents recruitment of excess immune cells to diseased tissues. It is a non-antibacterial analog of the well-known antibiotic azithromycin, that is extensively used in many diseases of the lungs including Cystic Fibrosis.
The drug’s potential in lung disease was elaborated in the recent research paper Azithromycin analogue CSY0073 attenuates lung inflammation induced by LPS challenge (Balloy, V. et. al.: 2014), published in the British Journal of Pharmacology.
“As a small innovative drug discovery services company, gaining an orphan designation is a major achievement for Synovo and demonstrates the depth and breadth of the skills and capacities of the company and its people” said Synovo founder and Managing Director Michael Burnet.
Synovo Pharmacist Enriqueta Vallejo added: “Synovo proposes a better control of the inflammation and the excessive immune response in Cystic fibrosis, limiting degenerative processes, reducing the treatment with antibiotics, currently used for this purpose, to when they are really needed. Stopping the unnecessary use of antibiotics leads toless selection for multiple resistance and avoids a long-term issue in the clinic.
Synovo is now working with its partners and collaborators to move CSY0073 into clinical trials.
“The EMA’s decision is very welcome in confirming the strong scientific case for CSY0073, thus serving as testimony to the skills and ingenuity of our small team of chemists and pharmacologists,” said Renate Burnet, Synovo’s Business Development Manager.
“It also confirms that Synovo is a company able to discover and develop novel drug, based on a strong medicinal chemistry team, flexible pre-clinical development skills and accumulated expertise in pharmacokinetics,” added Ms. Burnet.
Orphan disease status
To qualify for EMA orphan designation, a medicine must:
- Be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating
- Address a condition whose prevalence in the EU is not more than 5 in 10,000 or unlikely to support commercial marketing
- Offer a diagnosis, prevention or treatment of the condition for which no other authorized or equivalent therapy exists
The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) examines applications for orphan designation. Following orphan designation, sponsors can benefit from a number of incentives, including protocol assistance and market exclusivity.
Synovo GmbH is a German-based pharmaceutical discovery services company providing medicinal chemistry, formulation, in vivo pharmacology and bio analytical services to pharmaceutical companies, biotech enterprises and academic institutes wishing to develop new drug candidates.
Synovo’s main pharmacological activities are based on assays and disease models for the selection of drug candidates with optimal in vivo properties. The company is also engaged in projects in the fields of anti-inflammatory, CNS and oncology drug optimization on behalf of clients from the pharmaceutical industry. Synovo works in partnership with public sector laboratories to improve its systems and extend its technologies to protein and nucleic acid drugs.
Synovo specialises in techniques to design, formulate and test compounds and for their ability to be directed to specific organs and disease states. Using state of the art pharmacology and analytical techniques, Synovo provides drug pharmacokinetics and distribution information using a minimum of compound and with the fastest turn-around times in the industry.
The company was founded by Dr. Michael Burnet, a former Zeneca project leader with a broad interest in chemical biology and its application in improving small molecule discovery efficiency. Its 30-strong team works in a new facility equipped with state-of-the-art air handling and climate control to ensure optimal working environment for chemistry and pharmacology studies.
Through collaborations with public sector and biotech partners, Synovo occasionally works on new projects in partner or risk sharing mode and CSY0073 is one such product. Other collaborators in the CSY0073 development were INSERM, The University of Perugia, The Czech Academy of Science, The University of Tübingen and the William Harvey Institute.
CSY0073 is an analog of azithromycin that maintains its anti-inflammatory effect while having no effect on bacteria, and in particular, not causing the loss of potentially useful normal flora of the lung and airways.
About Cystic Fibrosis
Cystic fibrosis is a chronic disease associated with the loss of chloride ion transport in the lungs and other major organs. This leads to changes in secretion, infections, lung inflammation and progressive loss of function. Through improved management of patients, life expectancy in developed countries has been steadily improving.
An important aspect Cystic Fibrosis management is the control of infections. Reduction in inflammation is also important but has taken a secondary role in the past. Various reports show that the antibiotic azithromycin is effective in Cystic Fibrosis because of a concurrent effect on inflammation.
Renate Burnet, Business Development Manager, Synovo
Tel: +49 7071 964325
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