The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given Nuformix approval to commence its NXP001 human pharmacokinetics studies.
The drug, which is the company’s lead asset, will be evaluated in an open-label study to compare the bioavailability of it to Merck’s Emend in healthy subjects.
Nuformix is developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting - a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients.
The primary objective of the study is to investigate the pharmacokinetics and bioavailability of single oral doses of NXP001, and dosing will commence in March 2019, with results expected by the end of the first half of 2019.
Dr Dan Gooding, Nuformix' chief executive, said: “Although expected, receiving approval to advance our first programme into human studies is a major step forward for our Company and our pipeline. 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.
"Completion of these studies will allow us to rapidly progress NXP001 as a cancer supportive care treatment."
He went on to note that in addition to triggering the payment of the final £2 million milestone by the firm's China market partner and advancing product registration in China, the approval and successful completion of the study will "significantly increase" Nuformix’ ability "to secure further commercial partnerships in other territories, with discussions on-going with multiple parties.”