NXP0024 Nov 2021 15:32
Adding value via inhaled delivery
NFX has particular expertise in inhaled therapeutics: CEO Dr Anne Brindley brings broad experience including a deep range of contacts drawn from the prior development and commercialisation of inhaled products, including Symbicort® and flutiform®, which are core products in a global asthma and COPD therapy market worth over $30bn6 , including at inhaled products specialist Skyepharma (now Vectura) and at Glaxo, AstraZeneca and J&J. The particular benefits of inhaled therapies include:
– Delivery direct to the site of action for lung diseases, achieving drug levels in a high concentration in the target tissue to produce a therapeutic effect via a dose which is a fraction of the oral dose (inhalation doses are typically in micrograms vs oral doses of milligrams).
– Reductioninsystemicsideeffectsbyvirtueofthelowerdosesnormallyrequired to elicit a positive effect
– Avoidinglivermetabolismtomaximisetheamountofdrugavailableinthebody to exert positive effects
– Faster onset of action directly to the main site of disease. 6 Analyst estimate
17
– Successful precedent set in other lung diseases for example, asthma, COPD, Cystic Fibrosis, for a range of therapies (anti-inflammatories, bronchodilators, antibiotics)
– Potential for real therapeutic value-adding, not just extending the IP.
– Thepotentialtocomplementstandardofcareadministeredviaadifferentroute
e.g. oral medicines, as a combination treatment for lung disease like IPF.
NFX’s initial focus is on developing a formulation of the drug to facilitate inhalation by the patient and intends to test the feasibility of rapid and deep penetration of the drug into the lungs using a nebuliser in the first instance during the early stage studies. While tranilast is generally well tolerated, uncommon adverse effects include liver and kidney problems that can be alleviated by reducing the dose. Nebulisation is an appropriate delivery system for a disease such as IPF, where lung function can be limited and additionally it is a cost-effect method of delivery especially for early studies.
Promising early data
There are limited, but promising, early data on NXP002 in preclinical lung tissue models, reported in December 2018, supporting the rationale in treating IPF and other fibrotic lung conditions. NFX carried out multi-patient tissue studies in partnership with Newcastle Fibrosis Research Group (NFRG) at Newcastle University, a renowned expert group in fibrosis disease models using a leading-edge human tissue model that closely replicates the clinical disease:
– Data demonstrates NXP002 inhibits fibrotic markers 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 that are relevant in IPF.
– NXP002 out-performed current standard of care treatment, pirfenidone (Esbriet).
Further
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