Kwangdong 'almost completes' phase 3 study of sexual desire treatment Vyleesi

Palatin Technologies, a U.S. pharmaceutical company, said that Kwangdong Pharmaceutical, its Korean partner, has nearly completed a phase 3 clinical trial in Korea for Vyleesi (ingredient: bremelanotide), a hypoactive sexual desire disorder (HSDD) treatment for women. 

Kwangdong licensed in Vyleesi in November 2017 and received approval for a crossover trial from the Ministry of Food and Drug Safety in May 2020.

While the company started recruiting participants for the trial last year, the process was delayed due to the Covid-19 pandemic. 

Kwangdong's phase 3 study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of subcutaneously injected Vyleesi in premenopausal women with HSDD with or without decreased arousal. 

"The study enrolled 193 patients with 180, or 93 percent, completing the study," Palatin said in a press release Tuesday (local time). "We anticipate data from the trial to come out by the end of this year with a potential regulatory submission in the first half of 2024."

Vyleesi is a melanocortin receptor (MCR) agonist that non-selectively activates MC1R, MC4R, MC3R, MC5R, and MC2R. 

Notably, MC4R is primarily expressed in the medial preoptic area (mPOA) of the hypothalamus and is thought to play an important role in female sexual function. 

Vyleesi is designed to treat decreased libido in women by acting on the MC4R. 

The U.S. FDA approved Vyleesi in June 2019 to treat HSDD in women.

In the U.S. trial, Vyleesi increased libido and reduced pain during intercourse significantly.

Kwangdong was unavailable for immediate comments regarding the issue.