Lipocine seeks partner for midphase NASH asset in pivot to oral CNS drugs

Lipocine has formalized its pivot toward central nervous system (CNS) disorders. The biotech, which was already seeking partners for a clutch of other assets, will now focus on the oral delivery of neuroactive steroids to treat conditions including postpartum depression.

Salt Lake City-based Lipocine built a pipeline that features a once-daily testosterone replacement therapy, a preterm birth prevention prospect and drug candidates against liver conditions including nonalcoholic steatohepatitis and cirrhosis. The most advanced assets have completed phase 2 clinical trials but, with its money box now containing $37.4 million, Lipocine has decided to focus its resources on other assets.

Lipocine CEO Mahesh Patel set out the thinking behind the changes in a statement, explaining that the narrowed focus will enable it to advance “a select number of candidates in active development and to manage our resources efficiently.” Patel hopes other companies will take on the remaining candidates. 

“We continue to believe in the value of our non-core candidates and have determined that the optimal way to advance these assets will be through partnership,” Patel said. “We believe that this strategy will allow us to diversify risk and can create opportunities for non-dilutive financing.”

The pivot ratchets up the focus on LPCN 1154, the oral neuroactive steroid that Lipocine is developing as a treatment for postpartum depression. Lipocine is testing the oral brexanolone formulation in a pilot pharmacokinetic bridge study that is expected to deliver data in the first quarter of 2023.

The timing of the data drop means Lipocine is on course to generate the data before it runs out of cash. Under the revised plan, the company expects its current cash reserves to support it for at least another year.