In the 2019 annual report, Neuren said the FDA Psychiatry Department who oversees FX had asked for extra tests such as animal models and additional manufacturing
Speaking of which, unsurprisingly given that it has now been more than four years since the completion of Phase 2, other companies are starting to move into this space.
From the Pharma Letter (although they seem a bit confused about ACADIA's trials)
https://www.thepharmaletter.com/article/fragile-x-race-hots-up-as-shionogi-ups-stake-in-tetra
Osaka, Japan-headquartered Shionogi (TYO: 4507) has moved a step closer to taking full ownership of rare disease specialist and co-developer Tetra Therapeutics.
The companies have been working together since December 2018 to promote the research and clinical development of BPN14770, to improve cognitive function.
Granted US Orphan Drug designation in April 2018, the candidate has shown an effect on cognitive impairment in non-clinical animal models, including in models of AD and Fragile X syndrome (FXS)
The firms hope the option will offer a more favorable safety profile compared with existing PDE4 enzyme inhibitors, with fewer adverse reactions such as nausea.
Tetra’s option faces competition from rival firms in this indication, however, including Australia’s Neuren Pharmaceuticals (ASX: NEU) which is developing trofinetide for FXS.
Tetra is currently conducting Phase II studies in AD and FXS, with top-line results expected in March 2020.
Neuren has partnered with Acadia Pharmaceuticals and is on track to launch in the USA in the second-quarter of 2021, pending approval, a timeline which would confer first-to-market advantage and potentially knock the wind out of Tetra’s sails.
Investment agreement
Based on its confidence in the research and the company, Shionogi says it has now signed a new investment deal with Tetra, taking 50% of the company.
It has also inked a merger agreement which includes an option right to make Tetra a wholly-owned subsidiary of Shionogi, if certain closing conditions are met.
Chief executive Isao Teshirogi said: “With the aging of our society, cognitive disorders are becoming a serious social issue. We believe BPN14770 has the potential to become an innovative new treatment to help solve this issue.”
He added: “This new collaboration with Tetra reinforces our steadfast commitment to advancing cutting-edge science in central nervous system (CNS) disorders including Alzheimer’s disease.”
Based in East Grand Rapids, Michigan, Tetra is also using TNF-blocking agents to try to lower the risk of Alzheimer’s disease (AD) for people with autoimmune disorders.
(20min delay)