Lipocine says testosterone replacement candidate's blood pressure impact is consistent with approved therapy

Lipocine Inc (NASDAQ:LPCN) said Wednesday that findings from a clinical study of its testosterone replacement candidate showed that its impact on blood pressure was consistent with recently approved therapy.

The clinical-stage biopharmaceutical company said it plans to resubmit its new drug application for TLANDO, with the Food and Drug Administration in the second quarter.

“We remain committed on bringing our patient-friendly oral testosterone product candidate to patients in a timely manner,” Dr. Mahesh Patel, chairman, president and CEO of Lipocine, said in a statement.

READ: Lipocine rallies after therapy candidate achieves meaningful liver fat reduction

Of subjects with baseline 24-hour average systolic blood pressure greater than 140 millimeters of mercury, 32% of them were less than or equal to that level at the end of study, according to the company. In addition, of subjects with baseline blood pressure less than or equal to that level, the company said 9.7% of the subjects were greater than that level at the end of study, the company said.

Separately, the company on Tuesday announced the acceptance of its abstract on LPCN 1144’s clinical results as part of the annual meeting of the European Association for the Study of the Liver, from April 10 to 14 in Vienna, Austria.

LPCN 1144 is being developed as a treatment of non-alcoholic steatohepatitis.

Shares of Lipocine slipped $0.30 to $2.16 in Wednesday’s Nasdaq trading.

Contact Dennis Fitzgerald at [email protected]

Story by ProactiveInvestors