Nuformix (LSE:NFX) said in its half-year report that the US FDA had granted Orphan Drug Designation in IPF for tranilast lystate, the active ingredient in its inhaled candidate NXP002, and that recent share issues raised gross proceeds of £1.23m to help it advance the programme.
The pharmaceutical development company, targeting unmet medical needs in fibrosis and oncology, reported the FDA decision and set out that the funds will be used to generate further value-enhancing data for NXP002.
It recorded a loss after tax of £346,577 for the six months to 31 March, with loss per share of 0.02p, cash of £930,283 and net assets of £1.64m at the period end.
"Our ongoing research and progressive external discussions validate that inhaled treatment of IPF via NXP002 remains a viable and attractive concept, and the FDA orphan designation is helping advance partnering discussions," said Dr Dan Gooding.
Nuformix summarised pre-clinical progress showing NXP002 can be delivered by a range of nebulisers at lung-appropriate droplet sizes, is well tolerated at high doses in vivo, produced clear inhalation dose responses across inflammation and fibrosis biomarkers, demonstrated strong anti-fibrotic and anti-inflammatory effects in ex‑vivo IPF lung tissue and showed additive benefits when combined with current standards of care.
A pharmacology review using human and AI methodologies indicated NXP002 regulates four fibrosis-driving pathways, including TGF-β, WNT/β-catenin and NLRP3, supporting translation across fibrotic organs.
The board said it will prioritise IP maintenance, KOL engagement and data package development while progressing partnering discussions aimed at securing a licensing, option or collaborative agreement for NXP002.
