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FX125L


FX125L is the lead, orally available somatotaxin, with completed Phase I clinical trials (single and multiple ascending dose studies) conducted in the US, involving over 100 healthy subjects.  

The potent anti-inflammatory activity of FX125L following oral administration has been clearly demonstrated in a wide range of animal models of disease in vivo, including rodent models of allergic asthma, RA, diabetic nephropathy and surgical adhesions, suggesting therapeutic doses in man in the range of 10mg-100mg once a daily and that FX125L may have in the clinic similar efficacy but better safety than corticosteroids and superior efficacy than montelukast.  The regulatory preclinical studies (including 90-days regulatory tox studies) with FX125L suggested a very favourable safety profile and a wide therapeutic range.  FX125L has optimal CMC characteristics and is obtained by a straightforward 3-step chemical synthesis with an extremely low cost of goods. GMP production has been established as well as the development and stability data of a capsule formulation to be used in Phase II trials.

 

 

FX125L showed excellent safety, was well tolerated in doses up to 30-fold the presumed therapeutic dose in man and its pharmacokinetics were linear with an elimination half life of about 25h. Exploratory pharmacodynamic data suggest that FX125L has a biological activity in man that is consistent with a broad anti-inflammatory profile. The clinical indications targeted with FX125L include respiratory disorders such as asthma and COPD, and other major inflammatory conditions such as RA, IBD, psoriasis or acne.

 

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