Cambridge, UK—Nuformix plc, a pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, has announced its commencement of clinical studies for the company’s lead asset, NXP001. Nuformix is developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting (CINV).
The primary objective of the study is to investigate the pharmacokinetics and bioavailability of single oral doses of NXP001. First dosing of NXP001 took place on March 20th in a cross-over study that aims to measure the relative bioavailability of NXP001 compared to Merck’s EMEND in healthy subjects. Dosing will complete during April 2019, with results expected by the end of H1 2019.
The data gathered from the trial will enable the company to confirm NXP001’s suitability for rapid development as a treatment for CINV, allowing current and future licensees to launch new products into the £16 billion oncology supportive care market. It will also trigger a final milestone payment of £2 million from Nuformix’s Chinese licensing partner, Newsummit Biopharma, and proceed with product registration process in China (Nuformix retains 10% royalty).
“The initiation of clinical studies for NXP001 marks a critical milestone for Nuformix, not just as a measure of the progress the Company has made, but also due to the associated technical and commercial significance. The results from the study will trigger payment of the final £2m milestone from Newsummit Biopharma and advance product registration in China,” said Dr. Dan Gooding, CEO, Nuformix.
“From ongoing discussions with additional licensing partners, we believe that NXP001 can address key issues that currently restrict patient access to highly efficacious treatment for their CINV. Data confirming Nuformix’s patented approach as a solution to CINV applications is the final piece in the validation of our technology, increasing Nuformix’s ability to conclude further commercial partnerships globally.”
Nuformix received approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) to commence human pharmacokinetics studies for NXP001 in late February.
Gooding noted in a press release that “Although expected, receiving approval to advance our first program 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…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.”
Back in December, Nuformix also announced results from the completion of a preclinical trial for its NXP002 fibrosis program in human idiopathic pulmonary fibrosis (IPF) against standard of care. Multi-patient tissue studies were performed in partnership with the Newcastle University Fibrosis Research Group, U.K., using a human tissue trial model that closely replicates the clinical disease.
Data demonstrated that NXP002 candidates strongly inhibit fibrosis ex-vivo, even in very severely fibrotic patient tissue, giving strong support for treating IPF and other fibrotic lung conditions. In addition, NXP002 demonstrated specific action measured against key inflammatory targets, and out-performed the current standard of care treatment, Esbriet (pirfenidone). Despite this being a challenging model of end-stage disease, the outcomes are considered highly positive and a portent for wider applications in other fibrotic lung conditions. Nuformix now seeks to optimize delivery of a candidate within its NXP002 program to
maximize efficacy and tolerability, before moving into patient studies.
“This promising data gives us confidence in our ability to both inhibit fibrosis and attenuate inflammation in patients without these side effects,” added Gooding. “Newcastle University use a highly innovative new human tissue model, which has the potential to become the new gold standard for pre-clinical studies. These findings are important for IPF patients and show our NXP002 program can play an important role in improving on current treatment options and extending both life and its quality.”