MHRA gives go-ahead to Nuformix for human studies

Pharmaceutical development company Nuformix has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to begin human pharmacokinetics studies for its lead asset, NXP001, it announced on Wednesday.

The London-listed firm said the approval would allow it to initiate the first dosing of NXP001 in an open-label study to compare the bioavailability of NXP001 to Merck's ‘EMEND’ in healthy subjects.

Nuformix was developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting (CINV), explaining that the condition was a large, under-exploited and growing market, which in demographic terms comprised one third of global cancer patients.

The primary objective of the study was to investigate the pharmacokinetics and bioavailability of single oral doses of NXP001.

Dosing would begin in March, with results expected by the end of the first half of 2019.

“Although expected, receiving approval to advance our first programme into human studies is a major step forward for our company and our pipeline,” said Nuformix chief executive officer Dr Dan Gooding.

“The MHRA's decision validates the speed to clinic of our cocrystal approach without the need for further safety data and sets a precedent for our broader pipeline.”

Dr Gooding said completion of those studies would allow the firm to rapidly progress NXP001 as a cancer supportive care treatment.

“In addition to triggering the payment of the final £2m milestone by our China market partner and advancing product registration in China, the approval and successful completion of the study will significantly increase Nuformix's ability to secure further commercial partnerships in other territories, with discussions on-going with multiple parties.”