Nuformix Regulatory News (NFX)

30 May 2022

Nuformix plc

("Nuformix" or the "Company")

Corporate Update

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is now able to provide an update on the Company's assets and other corporate matters.

NXP002

NXP002, a new form of tranilast, is the Company's pre-clinical lead asset and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").

As announced on 25 November 2021, positive data was received from initial pre-clinical studies. In vitro studies demonstrated NXP002's feasibility for formulation as a simple and stable solution with suitable properties for delivery via nebulisation. 

In vivo studies evaluated NXP002's pharmacokinetics when delivered by nebulisation. Results demonstrated that NXP002 can be efficiently delivered to the lung.

Further in vivo studies evaluated the pharmacodynamics of NXP002 when delivered by nebulisation. This study showed that inhaled NXP002 could dose-dependently regulate the production of inflammation and fibrosis-relevant cell mediators in response to a lipopolysaccharide ("LPS") challenge.

Following the results of these studies, a final planned pre-clinical study was commissioned to assess the duration of action with the gap between inhaled NXP002 and the LPS challenge extending from 30 minutes, as in the first study, in various stages up to eight hours. However, the Contract Research Organisation ("CRO") undertaking the study had a protocol failure, voiding the study. The CRO repeated the study as per the protocol.

The repeat study has recently concluded. The results, however, were inconsistent with the first in vivo study at all time points and also with the oral control. In the opinion of the Company and its development advisers, no positive or negative conclusions could be drawn from this study.

The Company, in consultation with the CRO, has therefore decided to move forward with further studies, including evaluation of a new formulation. New studies will examine both the pharmacokinetics of NXP002 as an inhaled product and further test its efficacy in repeat LPS challenge studies. The timing of results from this study is dependent upon the availability of slots with the CRO and is expected on or before Q1 2023.

NXP004

The Company has previously demonstrated the enhanced performance of NXP004 compared to olaparib's free form. Subsequently, additional pre-formulation studies have been completed confirming the superiority of the Company's recently patented cocrystal forms and a lead cocrystal has been selected to enter drug product development. Further updates will be announced in due course.

NXP001

Following the Company's signing of an exclusive global licensing agreement with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio continues to progress this asset. NXP001 is a proprietary new form of aprepitant which is currently marketed for cancer chemotherapy induced nausea and vomiting. The arrangement with Oxilio is allowing them to progress NXP001 without cost to the Company and Nuformix expects to receive milestone payments when the product completes clinical trials and ultimately royalties on any sales.

The board believes the Company has sufficient funds to undertake the planned studies on NXP002 and operate on current projections until Q4 2023.

Management

Following a search for a new Chief Executive Officer for the Company, utilising external consultants, no suitable candidate has been identified.

Commenting, Alastair Riddell, Executive Chairman of Nuformix, said: "We continue to believe that NXP002 is a valuable asset that can overcome the limitations and issues of tranilast being delivered orally. The further study, that we anticipate will confirm the previous findings, will commence as soon as the CRO is able. We anticipate results from these studies by Q1 2023. We have sufficient funds to conduct the studies on NXP002 and, based on our current projections, to continue to Q4 2023."

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About Nuformix

Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Company aims to use its expertise in discovering, developing and patenting novel drug forms, with improved physical properties, to develop new products in new indications that are, importantly, differentiated from the original (by way of dosage, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has a pipeline of preclinical assets with potential for significant value and early licensing opportunities.