Presentation

Initiator Pharma is a Danish clinical stage life science company with three clinical programs: drug candidates IP2018 and IPED2015 for treatment of erectile dysfunction of psychogenic and organic origin, respectively, and orphan drug candidate IPTN2021 for trigeminal neuralgia. All drug candidates belong to the drug class monoamine reuptake inhibitors and base on compounds modulating monoamine neurotransmitters e.g., dopamine, noradrenaline, and serotonin.

Recent highlights
Ph2b trial with IP2015 and Ph2a trial with IP2018 are both ongoing, with patient recruitment expected to be completed in H2 2022. In May, Initiator announced top-line Ph1 study results with single doses of IP2015, pregabalin as active control, and placebo in healthy male subjects to assess pain-reducing effects; the pain was induced by intradermal capsaicin. IP2015 showed statistically significant effect on allodynia (p=0.049) and showed a dose-dependent effect on the measured pain parameters. Pregabalin (p=0.083) and IP2015 (p=0.051) tended to reduce hyperalgesia yet not statistically significant compared to placebo. No unexpected adverse events were observed. A final report is expected in Q3. In July, Initiator announced that the company had resolved on a fully secured rights issue of approximately SEK 41M and a directed share issue to a financial advisor in connection to the rights issue.

Outlook
The company’s upcoming milestones include the completion of Ph2a proof-of-concept trial with IP2018, the completion of Ph1 proof-of-principle trial in neuropathic pain with IP2015, and the completion of Ph2b trial in erectile dysfunction with IP2015.