Sector News

La Jolla stops pivotal trial, parts company with CEO

November 26, 2019
Life sciences

La Jolla Pharmaceutical has stopped a pivotal trial of LJPC-401 after an interim review. The company disclosed the setback on the same day it revealed its CEO and president George Tidmarsh has left “to pursue other interests.”

LJPC-401, a synthetic form of human iron metabolism regulator hepcidin, moved into a pivotal trial in transfusion-dependent beta thalassemia patients with myocardial iron overload almost two years ago. After enrolling half of the targeted 100 subjects, La Jolla performed an interim analysis that found patients on LJPC-401 were doing no better than their peers on placebo against the primary and key secondary endpoints.

The finding led La Jolla to stop the pivotal trial, killing off near-term hopes of bringing the drug to market in the beta thalassemia population. La Jolla is yet to dump the drug altogether, although it is reassessing whether to continue development.

That response reflects the availability of more encouraging data from a phase 2 study in patients with hereditary hemochromatosis. The trial met its primary endpoint of change in transferrin saturation, which increases in line with the body’s iron stores, and also hit key secondary endpoints, leading La Jolla to characterize results from across the failed and successful studies as “mixed.”

La Jolla is now assessing whether the mixed results justify further investment in LJPC-401. Ultimate responsibility for that decision will fall on a new leader. Tidmarsh, who spent almost eight years at La Jolla, has left the company. La Jolla disclosed the immediate departure of its CEO and president on the same day it shared news of the mixed data on LJPC-401.

Shares in La Jolla fell more than 50% following the one-two punch delivered by the statements.

La Jolla board members Kevin Tang and Craig Johnson will oversee the company’s management team until a new CEO is found. That CEO will inherit a company focused on growing sales of Giapreza, a vasoconstrictor that brought in $15.8 million over the first nine months of the year, and winning FDA approval for malaria drug LJPC-0118.

By Nick Paul Taylor

Source: Fierce Biotech

comments closed

Related News

October 2, 2022

GSK names Julie Brown, a 25-year AstraZeneca veteran, its first woman CFO

Life sciences

Five years ago, GSK made headlines when it hired Emma Walmsley to become the first woman to run a major pharmaceutical company. Now the Big Pharma has brought in another woman to control the company’s finances. Julie Brown will be GSK’s next chief financial officer. Brown, currently the chief operating and financial officer at fashion and beauty brand Burberry Group, is set to replace Iain Mackay.

October 2, 2022

Moderna creates new launch preparation role, poaches Novartis exec as manufacturing lead

Life sciences

Moderna created a new role responsible for “building out the company’s organization to support its growing pipeline.” Starting first thing 2023, Juan Andres, Moderna’s manufacturing head, will step into this new role under the title president of strategic partnerships and enterprise expansion, the company said Thursday.

October 2, 2022

Torrent Pharma to acquire Curatio for $245.16m

Life sciences

The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment. Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn).