Palatin Technologies, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, has started its bremelanotide pivotal registration programme. The company has initiated its phase 3 reconnect study in the United States for the treatment of female sexual dysfunction (FSD).
"We are pleased to achieve this major milestone in the bremelanotide programme with the initiation of our phase 3 reconnect study in the US," stated Carl Spana, president and chief executive officer, of Palatin. "This is a key step in our global strategy to bring bremelanotide to market for the millions of women who have FSD and are seeking a safe and effective treatment." Dr. Spana further stated that, "Our recent $30 million financing has provided the financial resources to start the bremelanotide phase 3 pivotal registration programme and timing flexibility regarding partnering for the US and other non-European territories."
The start of the reconnect study phase 3 clinical trial in the US triggers a development milestone payment of €2.5 million (~$3 million) from Gedeon Richter Plc, Palatin's partner in Europe for bremelanotide for FSD. Palatin is also eligible to receive regulatory and sales milestones, and low double-digit royalties on net sales in the European licensed territory.
Protocol 301 of the reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. It is designed to randomize approximately 550 women in North America to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment. Initial data from the study is anticipated in the middle of calendar year 2016. More information on the trial protocol, including trial design, inclusion/exclusion criteria, etc., can be found at http://clinicaltrials.gov.
Palatin is developing bremelanotide subcutaneous for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Female Sexual Dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We will seek approval of bremelanotide for the largest category of FSD, hypoactive sexual desire disorder. To establish a diagnosis of FSD, one or more of the disorders making up FSD must be associated with personal distress, as determined by the affected women.i A study of more than 30,000 U.S. women in 2008 reported an age-adjusted point prevalence of sexual difficulties causing personal distress in 12 per cent of respondents.ii
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand, as-needed treatment and has the potential to transform the treatment of patients with FSD.