Initiator Pharma screening for Phase 2a trial for IP2018 ongoing
Initiator Pharma A/S, a clinical-stage biotech company today announced that the screening of patients for the Phase 2a clinical trial with IP2018 is ongoing and, pending the Covid-19 situation, the first dosing of patients is expected shortly.
Initiator Pharma A/S, a clinical-stage biotech company today announced that the screening of patients for the Phase 2a clinical trial with IP2018 is ongoing and, pending the Covid-19 situation, the first dosing of patients is expected shortly.
IP2018 is a candidate drug being developed for the treatment of sexual dysfunction in patients with major depressive disorder or more generally psychogenic Erectile dysfunction (ED). The Phase 2a trial is a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of IP2018 in young, depressed, erectile dysfunction (ED) patients. The primary objective of this study is to investigate the effects of IP2018 on penile rigidity and tumescence using visual sexual stimulation test. The study will be conducted in 24 patients at the MAC Phase I unit in Manchester, UK. Pending the Covid-19 situation first dosing to patients is expected to take place shortly.
“Due to the Covid-19 situation in UK, the patient recruitment pace for our IP2018 Phase 2a trial has been slower than expected. However, we expect to be able to proceed with the active part of the trial shortly, and we’re still aiming for top line results at the end of the first half of 2021,” says CEO, Claus Elsborg Olesen.
For more information about Initiator Pharma, please contact:
Claus Elsborg Olesen, CEO
Telephone number: +45 6126 0035
E-mail: ceo@initiatorpharma.com
The information was provided by the contact person above, to be published on October 1, 2020, at 14:00.
About Initiator Pharma
Initiator Pharma is a clinical-stage biotechnology company based in Aarhus, Denmark. The company’s main asset, IPED2015, is a candidate drug intended for patients with erectile dysfunction. The treatment is expected to improve the quality of life for a growing number of patients who are not responding to or cannot be treated with existing drugs on the market. Read more on www.initiatorpharma.com.
IP2018
IP2018 is a monoamine reuptake inhibitor that inhibits the synaptic reuptake of serotonin, noradrenaline, and dopamine. IP2018 preferentially inhibits serotonin followed by dopamine reuptake, while it has markedly less effect on the noradrenaline reuptake. IP2018 has antidepressive effect in animal models for depression and effect on erectile function. There is solid preclinical data package, a phase I study, and a positive emission tomography (PET) study showing binding in patients to the serotonin reuptake and dopamine reuptake transporter.