• Collaboration with funding of development activities gives Boehringer Ingelheim exclusive option to purchase certain Autifony assets to treat serious CNS disorders
  • Most advanced compound is in Phase Ib studies, with one trial ongoing in patients with schizophrenia

STEVENAGE, UK, and INGELHEIM, Germany I December 18, 2017 I Boehringer Ingelheim and Autifony Therapeutics Limited (“Autifony”) today announced that they have signed an agreement about certain aspects of Autifony’s voltage gated potassium channel modulator platform. Boehringer Ingelheim now has an exclusive option to purchase Autifony’s Kv3.1/3.2 positive modulator platform. Included in the agreement is the lead compound AUT00206, a novel, orally active small molecule that is currently being evaluated in two Phase Ib studies, including one in patients with schizophrenia.

Boehringer Ingelheim will pay Autifony a €25 million upfront fee, with the possibility of further payments of up to €17.5 million during the option period based on achievement of short term milestones. The total potential transaction may sum up to €627.5 million upon reaching development and pre-commercialisation milestones once Boehringer Ingelheim has exercised its option. Further financial details were not disclosed. 

Schizophrenia is the most advanced indication under development with AUT00206. Preclinical studies using models relevant to the pathophysiology of schizophrenia suggest that AUT00206 has the potential to treat cognitive and negative symptoms of schizophrenia, as well as positive symptoms with fewer side effects than current anti-psychotic drugs. Cognitive and negative symptoms are poorly treated by antipsychotic drugs and are associated with significant functional impairment and reduced quality of life for patients. In addition to schizophrenia, both Autifony and Boehringer Ingelheim have a strong interest to explore the Kv3.1/3.2 mechanism for other indications, including hearing disorders and orphan CNS disorders, such as Fragile X Syndrome.

Dr. Jan Poth, Therapeutic Area Head CNS and Immunology at Boehringer Ingelheim, stated: “This partnership opens up the possibility of testing clinically an unprecedented therapeutic concept for the treatment of schizophrenia and to develop novel compounds with significant value to the patient. Schizophrenia is a challenging indication for drug development, and the companies’ commitment and combined expertise will accelerate progress towards a much-needed new medicine for patients with this serious disorder.”
The program aligns with Boehringer Ingelheim’s drug discovery strategy for neuropsychiatric diseases, which focuses on exploring the neurobiological basis of certain key symptom domains that can occur across a range of mental disorders, such as schizophrenia, Alzheimer’s disease and depression.

Dr. Charles Large, CEO of Autifony Therapeutics said: “Autifony has pioneered the development of Kv3.1/3.2 modulators for the treatment of schizophrenia, Fragile X syndrome, and disorders of hearing. Our compounds have the potential to change the treatment paradigm for these disorders, and we welcome the opportunity to collaborate with Boehringer Ingelheim, who will bring valuable expertise and resources as we progress through the next phases of clinical and non-clinical development.” He continued: “ We are also grateful for the support from Innovate UK’s Biomedical Catalyst, which has enabled a highly successful collaboration between Autifony, the Universities of Manchester and Newcastle, and the Institute of Psychiatry, Psychology and Neuroscience at Kings College London.”

About Autifony Therapeutics Ltd
Autifony Therapeutics is an independent UK based biotechnology company formed in 2011 as a spin-out from GSK, which retains equity in the company. The Company is focused on the development of high value, novel medicines to treat serious diseases of the central nervous system.  It is funded by SV Health Investors, Touchstone Innovations plc (now part of IP Group), Pfizer Venture Investments, International Biotechnology Trust PLC, and UCL Business plc.    www.autifony.com

About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales. 
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com (link is external).

About Schizophrenia
Schizophrenia remains a major healthcare challenge throughout the world. Patients with the condition have a poor quality of life and prognosis. Antipsychotics are the main treatment but in up to a third of people with schizophrenia, the illness shows a poor response to these drugs. Particularly debilitating are cognitive symptoms of schizophrenia, such as poor decision making, attention and memory, and negative symptoms, such as social withdrawal and anhedonia, which make work and relationships difficult to sustain. Side effects of the currently approved antipsychotic drugs are also problematic, including weight gain, diabetes, heart disease, movement disorders and sexual dysfunction. There is a clear need for more effective drugs with fewer side effects.

See ‘The Abandoned Illness’, a report by the Schizophrenia Commission, November 2012.

About Innovate UK and Biomedical Catalyst
Innovate UK is the name for the UK’s innovation agency. Taking a new idea to market is a challenge. Innovate UK funds, supports and connects innovative businesses through a unique mix of people and programmes to accelerate sustainable economic growth. Catalysts are run jointly by Innovate UK and the Research Councils. A Catalyst is a form of research and development funding which focuses on a specific priority area and aims to help take projects from research to as close to commercial viability as possible. The Catalyst model supports projects in priority areas where the UK research base has a leading position and where there is clear commercial potential. 
For further information visit www.gov.uk/innovateuk

SOURCE: Boehringer Ingelheim