FP-025:Asthma; Acute Exacerbations of COPD/ILD

FP-025 is a highly selective (non-hydroxamate), oral non-competitive small molecule inhibitors of Matrix Metalloproteinase-12/Macrophage elastase (MMP-12), an enzyme that acts as a key mediator of matrix degradation and remodeling in both normal development and maintenance.

FP-025 is well tolerated in healthy human volunteers and allergic asthmatic patients upon single and repeat dosing, and exhibits good single and multiple dose oral pharmacokinetics. For detailed study design, please visit:

Single ascending dose (SAD):
https://clinicaltrials.gov/ct2/show/NCT02238834?term=FP-025&rank=1
(Identifier:NCT02238834)

Multiple ascending dose (MAD):
https://clinicaltrials.gov/ct2/show/NCT03304964?term=FP-025&rank=2
(Identifier:NCT03304964)

FP-025 is currently in a P1b/2a proof-of-concept (PoC) study in allergic asthmatic patients challenged with an allergen (house dust mite). For detailed study design, please visit:

https://clinicaltrials.gov/ct2/show/NCT03858686?term=FP-025&rank=1 
(Identifier: NCT03858686)


Asthma and acute exacerbation of COPD


Asthma and chronic obstructive pulmonary disease (COPD) are two of the most common lung diseases in the world. Asthma, a chronic inflammatory disease of the trachea, is characterized by varying and recurrent symptoms, reversible airflow obstruction, and bronchospasm; COPD, a multifocal and multicentric chronic respiratory disease, can result in high disability and a high mortality rate. In recent years, countries around the world have eyed on the great importance of chronic obstructive pulmonary disease (COPD) because of its high and increasing prevalence.

In asthma and COPD patients, the expression of MMP-12 in their lungs is significantly higher than normal controls, accompanied by the activation of 
eosinophils, and airway inflammation. Eosinophils can cause respiratory muscle tension in asthma patients, and can also cause neutrophilic inflammatory response in COPD patients. Highly selective  MMP-12 inhibitors can suppress eosinophilic inflammation, which can be effective in treating asthma and COPD. 

So far in the market, there is yet to have any treatment that can modify the progression of asthma and COPD. Most available therapies involve the use of bronchodilators and inhaled steroids, which are only symptom relief medications. There remains a significant unmet medical need in both asthma and COPD. 
The highly selective MMP-12 inhibitor developed by Foresee will be a new type of drug with the potential of revolutionizing the treatment method for patients with asthma and COPD. 

Acute exacerbation of COPD as "an acute event” characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations. This generally includes an acute change in one or more of the following cardinal symptoms: cough increases in frequency and severity, sputum production increases in volume and/or changes character, dyspnea increases. This condition leads to a change in medication. Additional use of FP-025 may alleviate or reduce COPD exacerbation symptoms and frequency.