Galectin Therapeutics Inc. (GALT)

[thefamilyman]

This is good news for GALT. Its been awhile, but is my memory correct that this was the only potential competitor for reversing fibrosis that was in human trials? If so, this could be really good for GALT.

I am a little disturbed that the FDA let LJPC get this far into a Phase 2b study before hitting the company with this new requirement. Further, it is apparently a requirement that the company may never be able to meet. The FDA raised no issues "related to patient safety or preclinical toxicology" but imposed a requirement that killed the drug anyway? That is a scary thought but I guess it is just another bureaucratic day at the FDA...

May 7, 2015
SAN DIEGO–(BUSINESS WIRE)– La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced a reprioritization of its product development programs. As a result of this reprioritization, La Jolla will discontinue development of its polysaccharide-based galectin-3 inhibitors, GCS-100 and LJPC-1010. ...

The portfolio reprioritization is the result of both the addition of the next-generation gentamicin derivative program and a recent interaction with the U.S. Food and Drug Administration (FDA) regarding La Jolla’s galectin-3 inhibitor program. In this interaction, the FDA indicated that the Company would be required to conduct additional chemical characterization of GCS-100 prior to further clinical development. GCS-100 and LJPC-1010 are complex polysaccharide mixtures that cannot be readily chemically characterized using conventional analytical methods, and the Company believes that the timeframe and ultimate success of developing analytical methods that would satisfy the FDA’s requirements are highly uncertain. There were no issues raised by the FDA related to patient safety or preclinical toxicology.

The Company will continue to treat and follow patients already enrolled in its Phase 2b study in diabetic patients with advanced chronic kidney disease, but will stop enrolling new patients. ...