Fri, 22nd Mar 2019 07:00
("Nuformix" or the "Company")
Nuformix Commences NXP001 Clinical Trial
First patient dosed with Nuformix cocrystal product
Cambridge, UK, 22 March 2019: Nuformix (LSE: NFX), the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces it has commenced clinical studies for the Company's lead asset NXP001.
NXP001 is in development as a treatment for chemotherapy-induced nausea and vomiting ("CINV"), a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients.
First dosing of NXP001 took place successfully on 20 March 2019 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 end 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 £16bn oncology supportive care market
- Trigger a final milestone payment of £2m from its Chinese licensing partner, Newsummit Biopharma, and proceed with product registration process in China (Nuformix retains 10% royalty)
- Progress on-going discussions for licensing rest of world rights to NXP001 for CINV
- Substantiate further product development opportunities for the NXP001 programme to generate significant additional future value
- Validate its underlying strategy, technology and IP by rapidly generating clinical data in a cost-effective manner to support out-licensing activities and generate revenue
Dr Dan Gooding, CEO, Nuformix plc, said: "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.
"From on-going 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."
Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the publication of this announcement via a Regulatory Information Service and accordingly, this inside information is now considered to be in the public domain.
Dr Dan Gooding, Chief Executive Officer
+44 (0)1223 627222
Optimum Strategic Communications
Mary Clark, Supriya Mathur
+44 (0) 203 950 9144
About Nuformix plc www.nuformix.com
Nuformix is a pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs. Nuformix's risk-mitigated development strategy has resulted in a pipeline of discoveries through which it has developed and patented novel cocrystal forms of approved small molecules.
Nuformix has created an IP portfolio of granted patents covering cocrystal forms of five small molecule drugs. Nuformix is targeting high-value unmet needs with its lead programmes in oncology supportive care: NXP001 and fibrosis: NXP002.
Nuformix was established in Cambridge in 2009 and has invested in pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities.
Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.
Nuformix is developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting ("CINV"). NXP001 is cocrystal-based product containing the NK-1 antagonist, aprepitant. Aprepitant is the active ingredient in Emend® (Merck) marketed globally for the treatment of CINV. CINV is a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients. NXP001 will enable new product entries into the oncology supportive care market, currently valued at over £16bn.
EMEND® (aprepitant, NK-1 antagonist) was developed by Merck and is approved worldwide for the treatment of CINV and post-operative nausea and vomiting (PONV). The NK1-based treatment regimen is globally recognised as the most efficacious in treating CINV and is first-line therapy according to NCCN and NICE guidelines for all highly emetogenic chemotherapy agents.