According to a publication from Scleroderma News, the first patient in the study of experimental cutaneous systemic sclerosis (SSc) drug AVID200 has been enrolled in the ongoing phase 1b clinical trial designed to determine safety and tolerability of the drug in adults.
The study is being conducted in two locations: the Hospital of Special Surgery in New York, and the University of Pittsburgh Medical Center. Some 24 patients with SSc are expected to be enrolled in the trial.
Avid 200, the brainchild of American biotech company Forbius, was designed to inhibit the activity of certain molecules involved in skin fibrosis (excessive scarring of the skin). Two molecules in particular, TGF-beta 1 and 3, are well-known to be positively correlated with the severity of SSc.
For a long time, the safe inhibition of TGF-beta molecules has been doggedly pursued by researchers as a potential breakthrough in the treatment of fibrotic disease. TGF-beta inhibitors have existed in some form for a while now, but they’re not very selective in the molecules they affect. This non-selective nature can lead to some severe adverse side effects. Forbius hopes that unlike earlier TGF-beta inhibitors, AVID200 will act only on TGF-beta 1 and 3, thereby avoiding some of the associated side effects of that drug class.
About the 1b Trial
Participants in the 6-week open label trial will be intravenously injected with a dose of AVID200 every two weeks. At the end of the first treatment cycle, if the drug seems to be not safe and non-toxic, patients will receive two additional injections over two more treatment cycles.
In this stage of testing, scientists are primarily concerned with determining the drug’s safety and tolerability rather than its effectiveness in treating SSc. However, that’s no reason to dismiss the news entirely. SSc patients are eager for a new breakthrough therapy, and AVID200 might one day represent just that if all goes well in these early trials.
Most drugs manage to pass the first stage of clinical testing. If AVID200 proves safe to use in the anticipated quantities, then it will advance to phase 2 trials. Phase 2 trials are concerned primarily with the drug’s effectiveness in treating its intended condition, meaning Forbius will have to make it at least that far before getting too excited at the prospect of marketing AVID200.
Although it’s early in AVID200’s clinical life, researchers are excited at the prospect of a more selective TGF-beta inhibitor. Do you think AVID200 will be better than previous inhibitors, or little improvement? Share your thoughts with Patient Worthy!