Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, will focus its resources on developing its clinical stage pipeline for rare diseases. In pursuing this strategy, Addex will advance current clinical and pre-IND programmes in certain rare diseases where orphan drug designation can be reasonably achieved in the major commercial markets - US, Europe and Japan.
While executing this strategy and to maximize potential clinical success in at least two programmes over the next 12 months, the company will reduce its overall cost structure, particularly around its early-stage discovery efforts, while maintaining its core competency and expertise in allosteric modulation. The result will be a development-focused company with a year cash runway. In addition, the company will seek to increase its cash position through non-dilutive partnerships by monetizing its platform capability as well as current discovery programs via licensing and strategic transactions. Finally, to improve the Company's liquidity and long term outlook, Addex will secure a listing on a US stock exchange.
The company plans to focus its efforts on its current pipeline: dipraglurant, an mGlu5 negative allosteric modulator (NAM) currently in phase II development for the treatment of Parkinson's disease Levodopa Induced Dyskinesia as well as certain rare dystonias; ADX71441 a GABAB-R positive allosteric modulator (PAM) expected in phase I studies by mid-year for the treatment of Charcot-Marie-Tooth neuropathy (CMT1a); and an oral mGlu4 PAM currently in pre-IND studies for the treatment of multiple sclerosis.
"The transformation of Addex into a development focused company is an important step in driving future success," said Bharatt Chowrira, CEO at Addex. "While both data and partnering discussions continue to support the advancement of dipraglurant in the treatment of Parkinson's disease Levodopa Induced Dyskinesia, we have decided to invest our own resources to advance dipraglurant into phase II studies for rare dystonias. We plan to apply for orphan drug designation while simultaneously seeking a partner to fund the larger non-orphan indications of dipraglurant such as PD-LID, anxiety and depression. In addition, we expect to complete phase I testing of our GABAB-R PAM while seeking orphan drug designation for CMT1a. To maximize the resources that we can dedicate to these clinical opportunities, we will look broadly at reducing our overall cost structure including our discovery capability; however, we will continue to maintain the core competencies that have made us a leading allosteric modulator R&D Company. We believe that these measures will position Addex for long-term success and build significant shareholder value."
Following a careful review of Addex operations over the past several months, the management and the Board of Directors decided that the Company should focus its capital and resources on significant pipeline opportunities in rare disease markets. To that end, Addex will reduce the size of its operations in Geneva. Changes to organisational structure and operations will focus on advancing pipeline programmes but will ensure that Addex maintains its core competencies and leadership position in oral small molecule allosteric modulator-based drug discovery.
"The Board of Directors fully supports the strategic direction taken by the Company," said André J Mueller, chairman of Addex. "The Board believes Addex is a world class research and development organisation capable of delivering on the promise of its pipeline in rare and orphan diseases. Our objective is to maximize our resources to recognise both near and mid-term key value drivers while providing a stronger financial basis for the future."
As part of the reorganisation and as required under Swiss law, a consultation process has been initiated. During the consultation period, the Company will investigate a variety of options to determine the optimal organizational structure and resulting operations necessary to execute this strategy. An announcement detailing the changes to organisation and operations will be made shortly thereafter.
"Addex is making excellent progress in advancing its proprietary pipeline of novel oral small molecules against a number of validated high-value targets," said Graham Dixon, CSO at Addex. "Positioning our pipeline in the rare disease space will allow us to create significant shareholder value by advancing programmes to key value inflection points without partners. Expected milestones in 2013 include: starting a phase IIa trial in a rare disease indication with dipraglurant, starting a phase I trial with ADX71441 with the intent to move rapidly to a phase II study in CMT1a, selecting a clinical candidate for our mGlu4 PAM programme and targeted completion by Janssen Pharmaceuticals, Inc. of the phase II a study with ADX71149 in patients who have anxiety and major depressive disorder. We are confident in our ability to execute on this new strategy and look forward to reporting clinical results on our programmes throughout the year."
Cash utilization for the year ended 2012 is CHF20.8 million resulting in a cash balance at 31 December 2012 of CHF15.3 million in line with guidance of CHF20-21 million and CHF15-16 million, respectively. Based on the current financial plan, current cash levels are sufficient to sustain operations through year end 2013.
Addex Therapeutics is a development stage company focused on advancing innovative oral small molecules against rare diseases utilizing its pioneering allosteric modulation-based drug discovery platform.