La Jolla Pharmaceutical Company (NASDAQ:LJPC) Halts GCS-100 And LJPA-1010 Trials On FDA Concerns

La Jolla Pharmaceutical Company (NASDAQ:LJPC) has brought to halt, the clinical trials of the GCS-100 and the LJPA-1010 drugs due to the strict regulations of the U.S. Food and Drug Administration (FDA). George Tidmarsh, CEO, La Jolla, said the decision to terminate the projects was not an easy one, but this was in the company’s interest and would help them in focusing on other projects. For now, the company would continue the treatment in the patients who have already participated in the study, but new enrollments are on halt.

The GCS-100 is a chronic kidney disease drug and LJPC-1010 is a drug for non-alcoholic steatohepatitis (NASH), and while the first was in Phase IIb, the latter was in a pre-clinical trial stage. According to La Jolla, both the treatments slow down the formation of the galectin-3 protein and are a complex blend.

FDA Road Block For La Jolla

FDA had asked the company to break down the complex mixture and analyze their properties before entering into a later development stage. La Jolla stated that they were had to figure out the trial method that would help them adhere to the FDA regulations and get approval for their drugs. Also, this is a time-consuming process and so the plan to keep the projects aside for the time being, seems a wiser move by the company.

Future Plans

La Jolla Pharmaceutical Company (NASDAQ:LJPC) was now mulling to out-license both the drugs to another company that can continue the clinical trials on the drugs and take them forward. The company is also planning to start the Phase III clinical trials of the LJPC-501 drug for hypotension and LJPC-401 that is used to treat excessive iron.

These are the gentamicin derivative programs of the company and breakthrough treatments that will help the company enhance its portfolio. Meanwhile, the company has also collaborated for the acquisition of the Indiana University Research and Technology Center’s (IURTC) as part of the initiative. The technology of the IURTC would benefit in the research involved in the gentamicin derivative programs.

Tidmarsh said that the research would help in extending the benefits of the drug to the patient and achieve the desired results.

 

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John Eisler

John Eisler

John is a special projects and general assignment reporter, noted for breaking several exclusive stories.