Development Status

Bremelanotide (formerly PT-141)

Bremelanotide in Men

Bremelanotide has been evaluated in four Phase 2 efficacy studies enrolling more than 1,300 men. Plans to initiate Phase 3 clinical trials have been delayed following responses from the FDA raising serious concerns about the acceptable benefit/risk ratio to support progression into Phase 3 studies. Palatin is reviewing the FDA comments in the overall context of the program in order to determine next steps related to the further development of bremelanotide.

Key Clinical Findings from Phase 2 Studies:

• effective in a broad range of patients, including those with severe ED and those non-responsive to sildenafil
• efficacy in at-home studies is comparable to PDE-5 inhibitors
• up to 50% of ED patients were restored to a normal level of function
• co-administration with sildenafil shows superior efficacy
• side effects included:
• facial flushing
• nausea
• aftertaste
• post-nasal drip
• blood pressure increases

Bremelanotide in Women

Palatin has conducted a Phase 1 study in 32 pre-menopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A secondary endpoint in this study was the assessment of bremelanotide’s effect on vaginal blood flow. Results showed a significant difference in the increase in vaginal blood flow in subjects treated with bremelanotide versus placebo.

A Phase 2A pilot clinical study evaluating bremelanotide in 18 pre-menopausal women diagnosed with FSD has also been completed with favorable results.

Key Clinical Findings from Phase 2A Study:

• patients receiving Bremelanotide reported increases in their levels of sexual desire and genital arousal compared to placebo
• correlation found between sexual desire and genital arousal in patients receiving Bremelanotide
• side effects were mild, including:
  • nausea
  • headache
  • nasal congestion

A Phase 2 at-home study of bremelanotide in FSD patients has been completed, and the results are being analyzed.