Faust Pharmaceuticals announces Phase IIa clinical trial results for treatment of amyotrophic lateral sclerosis (ALS)

Faust Pharmaceuticals S.A., a clinical stage products company specializing in the discovery and development of drugs for diseases of the nervous system, today announced that it has completed a Phase IIa clinical trial of its lead molecule, FP0011, in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The results observed in patients showed this antiglutamatergic drug was safe and well-tolerated, as was indicated in the Phase I studies.

ALS is an orphan disease which affects between one and five people per 100,000 worldwide according to different estimates. It causes degeneration of the motor neurons which control voluntary movements and leads to progressive muscle weakness and atrophy.

One hypothesis is that the degeneration is caused by the presence of excessive glutamate in the synaptic cleft. Faust Pharmaceuticals' FP0011 inhibits the release of glutamate and moreover has neuroprotective properties which make it a candidate drug for the treatment of ALS and potentially for other neurodegenerative diseases such as Parkinson's.

The goal of this Phase IIa clinical trial was to acquire data on FP0011 patient tolerance and safety, and to check whether it was possible to administer FP0011 in combination with riluzole, currently the only ALS treatment on the market. The trial showed that FP0011, administered for one month at the doses of 60 and 120mg/day, did not modify plasma concentrations of riluzole, and displayed an excellent clinical and biological safety.

The trial was carried out at the Salpêtrière Hospital, Paris, under the supervision of Professor Vincent Meininger and Doctor Lucette Lacomblez. The double-blind study was conducted on a group of 24 ALS patients.

"In the quest for new therapeutic molecules, the results obtained with FP0011 confirm good tolerance and an excellent safety profile," said Professor Meininger. "Given that riluzole is the only treatment currently available for ALS, and the need to develop complementary therapies, we are eager to see FP0011 progress to Phase IIb."

"We're delighted to have completed the Phase IIa study successfully and pleased to have been working with the Salpêtrière team with its worldwide reputation for the quality of its clinical research into ALS," said Thomas C Seoh, CEO of Faust Pharmaceuticals. "We are now looking to carry out Phase IIb trials on FP0011 for neurodegenerative diseases such as ALS or Parkinson's disease."

He added: "We've achieved a good deal in the last 12 months at Faust. We completed Phase I clinical trials on 62 subjects, and a Phase IIa trial in ALS on 24 patients with FP0011. We are currently carrying out a further Phase IIa clinical trial with the same molecule on patients suffering from Parkinson's disease."