Lundbeck has announced that the phase IIa study (AMBLED) of its novel selective positive allosteric modulator of the glutamate 4 receptor, foliglurax, for the treatment of Parkinson’s disease did not meet the primary study endpoint.
There was no statistically significant difference in change from baseline in OFF time versus placebo after a 4-week treatment period. The difference in change from baseline versus placebo was 0.27h and 0.44h for the 10 and 30 mg doses (twice daily) respectively, as assessed by the Hauser diary. Neither of the foliglurax doses separated from placebo on dyskinesia (secondary endpoint). The study showed an acceptable clinical safety and tolerability profile in patients with Parkinson’s disease.
A difficult decision
The AMBLED study is a phase IIa randomized, double-blind placebo-controlled study involving 157 subjects diagnosed with idiopathic Parkinson’s disease for at least three years, being treated with a stable regimen of levodopa-based therapy and experiencing OFF time (end-of-dose wearing off) and dyskinesia. They received either 10 mg or 30 mg foliglurax twice daily as an adjunct to levodopa for a 28-day treatment period. The primary endpoint of the study was the change from baseline in the daily awake OFF time based on subject Hauser diary entries, while dyskinesia was assessed by the change from baseline in the UDysRS score as a secondary endpoint.
“We are disappointed that foliglurax did not demonstrate sufficient efficacy for patients living with Parkinson’s disease. We have made the difficult decision to discontinue the development of the foliglurax program to focus our resources on more promising programmes,” says Johan Luthman, EVP and head of R&D at Lundbeck.
Lundbeck is conducting additional analyses to understand the totality of the foliglurax data. The results from the study will be published in the near future following international publication guidelines, it states.