|La Jolla CEO George Tidmarsh|
La Jolla Pharmaceutical ($LJPC) is pulling the plug on a pair of projects--including one for the common liver disease NASH--after the FDA set out a difficult regulatory road ahead.
The company is ditching GCS-100, a drug in Phase IIb for chronic kidney disease; and LJPC-1010, a preclinical candidate for non-alcoholic steatohepatitis, or NASH. Each treatment works by inhibiting the protein galectin-3, and each is a complex mixture, La Jolla said.
During recent discussions with the FDA, regulators pointed out that the company would need to further break down just how the complex chemicals work before getting into late-stage development, and La Jolla "believes that the timeframe and ultimate success of developing analytical methods that would satisfy the FDA's requirements are highly uncertain."
The agency's feedback has nothing to do with patient safety for GCS-100 or preclinical toxicology for LJPC-1010, the company notes, and La Jolla is hoping to out-license the two drugs to some with the patience and expertise to advance them.
"While it was a difficult decision to discontinue our galectin-3 inhibitor programs, we believe that this is the right decision for the company and its stakeholders as we evaluate our portfolio opportunities and how best to allocate our resources," CEO George Tidmarsh said in a statement.
While La Jolla nixes those two assets, it's bringing in two more in the form of antibiotic treatments invented by the Indiana University Research and Technology Center. The pair of preclinical candidates are derived from gentamicin, a commonly prescribed hospital antibiotic, and La Jolla believes they could have a future as treatments for rare diseases.
The biotech's pipeline also includes LJPC-501, in Phase III for hypotension; and LJPC-401, a treatment for iron overload.
- read the statement
- get more on the gentamicin candidates