Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Primary Premature Ejaculation

The goal of this clinical trial is to learn if drug BP1.4979 works to treat primary premature ejaculation in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are:

• Does drug BP1.4979 increase the time to ejaculation during sexual intercourse?
• Do participants have a good safety and tolerability of drug BP1.4979? Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat primary premature ejaculation.

Participants will:

• Take drug primary premature ejaculation or a placebo per requested need prior to sexual intercourses for 12 weeks
• Visit the clinic 4 times for checkups and questionnaires completion and have 2 phone calls with the study team over a period of about 17 weeks
• Keep a diary of the intakes of the experimental drug, ejaculation time, ejaculation control, any unusual events concerning their health and any other medication taken

Premature ejaculation is meant when ejaculation occurs too quickly during sexual activity with a partner, often within one minute of penetration, in 75-100% of sexual encounters and for no other reason. This can be a source of frustration and distress for both partners. There are two main types of PE: lifelong (primary) PE, present from the first sexual experience, and acquired (secondary) PE, which develops later in life and is often associated with other sexual problems (such as reduced libido or erectile dysfunction).

The exact cause of PE remains poorly understood. In the case of primary PE, it may be linked to brain chemicals (such as serotonin and dopamine), nervous system problems or psychological factors.

Current treatments include drugs and non-drug therapies. Medication works by increasing serotonin levels in the brain. They may be authorised, such as dapoxetine (a short-acting antidepressant) and anaesthetic creams (often used to reduce sensitivity, e.g. prilocaine-lidocaine), or prescribed off-label, such as other antidepressants or analgesics (e.g. tramadol). However, these treatments are often of limited efficacy, leaving patients without satisfactory solution.

The objective of this trial is to develop an effective treatment for primary PE specifically and to address an unmet medical need by improving the quality of life of the patients concerned.

The drug under study, called BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can help men suffering from primary PE to better control their ejaculation. The study will compare BP1.4979 with a placebo (a tablet that looks identical but has no active ingredient), taken on demand before sexual intercourse, over a 12-week period.

The study is a double-blind trial compared to a placebo, which means that neither the participants nor the study doctors know who is receiving the study drug or the placebo so as not to influence the results obtained. The treatments will be assigned randomly (by drawing lots), thus forming one group receiving BP1.4979 and another receiving the corresponding placebo.

A visit to the clinical site is planned at the beginning of the selection phase. Participants will be asked to sign an informed consent form prior to any study-related procedure. During the screening phase, they will use a stopwatch to measure the time to ejaculation during sex with a female partner over a period of approximately four weeks and record these times in a diary.

Patients will then return to the clinical site to check whether they are eligible to take part in the study at the 'randomisation visit' and, if so, they will receive the study drug for one month's treatment.

Follow-up visits will take place at week 4 (safety tests and renewal of treatment for two months) and week 12 (final visit). A telephone call will be made at week 8 and week 13 (7 days after stopping treatment) to check or monitor any side effects.

Inclusion Criteria:

• Males aged 18 to 50 years old (both inclusive)
• Diagnosis of primary (lifelong) PE according to the investigator
• Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
• Confirmation at randomization visit that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period
• Patient must be able to provide an informed consent and voluntarily express a willingness to participate in this study, and must sign and date an informed consent prior to any study specific procedure
• Capability to participate in all study tests according to the investigator

Exclusion Criteria:

• Diagnosis of acquired PE, pseudo-PE or natural variable PE
• History of clinically significant abnormalities comprising cardiovascular (including especially prolonged QTc (>450 ms) and high degree (second and third) atrio-ventricular blocks)), hematological, neurological, and endocrine diseases
• Current therapy with any treatment which may impact PE from 4 weeks prior to the screening visit
• Current therapy with any treatment displaying dopamine D3 receptor agonist properties from 4 weeks prior to the screening visit
• Concomitant intake of psychoactive / chem-sex substances