The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the local Ethics Committee have approved Initiator Pharma’s clinical trial application (CTA) for Phase I trial to evaluate pain-reducing effects.

The planned Phase I study in the new IPTN2021 clinical programme will be carried out together with MAC Clinical Research, UK.

It will use the drug substance, IP2015, in healthy male subjects challenged with pain-inducing ingredient (capsaicin).

The clinical programme is targeting an orphan drug indication being developed to treat severe neuropathic pain, trigeminal neuralgia.

It is based on the company’s IPED2015 API, which has already demonstrated safety and tolerability in clinical trials and showed efficacy for erectile dysfunction.

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A monoamine reuptake inhibitor, IP2015 specially inhibits dopamine and serotonin reuptake.

It has also been used as the active pharmaceutical ingredient in the IPED2015 programme, which is now undergoing a Phase IIb trial in 120 patients to treat organic erectile dysfunction.

Initiator Pharma CEO Claus Elsborg Olesen said: “I’m very pleased we have received the approval to start this exploratory Phase I trial for our new IPTN2021 programme targeting the orphan drug indication trigeminal neuralgia.

“The study will provide important pain-related efficacy, biomarker and safety information to support the planned clinical development of our drug substance IP2015 into relevant pain indications.

“We hope to be able to start dosing the first patients early next year. Our intention is to follow up this trial with a Phase II trial, including trigeminal neuralgia patients.”

The company expects subject enrolment and dosing to begin early next year.

In March 2020, Initiator Pharma reported favourable data from the Phase IIa study that assessed IPED2015 in severe erectile dysfunction patients.