Initiator Pharma files CTA for Phase I study with IP2105 in relation to assessment of pain reducing effects

Initiator Pharma A/S, a clinical-stage Life Sciences company, announced today that it has filed a Clinical Trials Application for its planned Phase I study with IP2105 in healthy subjects challenged with pain inducing ingredient (capsaicin)

Initiator Pharma has filed its Clinical Trial Application (CTA) for its planned Phase I study in healthy male subjects with IP2015 to the Medicines & Healthcare products Regulatory Agency, MHRA, UK. Subject inclusion and dosing is expected January 2022. The study will be carried out in collaboration with MAC Clinical Research, UK, as a single site study.

“Together with MAC Clinical Research, UK, we have designed this exploratory Phase I trial studying anti-nociceptive effects related to induction of pain – this study type and design is generally used by the pharma industry as one of the first clinical assessments related to pain. Capsaicin (ingredient in chili peppers) induces a localised release of neuropeptides resulting in localised hyperaemia (flare), hyperalgesia and allodynia. These effects are similar to those seen in neuropathic pain. Thus, this study will provide supportive pain related efficacy, biomarker and safety information to the planned clinical development of IP2015 into relevant pain indications”, says Claus Elsborg Olesen, CEO of Initiator Pharma.

IP2015

IP2015 (former named IPED2015) is a monoamine reuptake inhibitor preferentially inhibiting dopamine and serotonin reuptake. IP2015 is superior to duloxetine in the rat formaldehyde pain model and the rat sciatic chronic constriction injury (CCI) model. Moreover, safety of IP2015 is superior compared to duloxetine, and no risk for drug interactions has been detected.

IP2015 is also the active pharmaceutical ingredient used in the IPED2015 program, that is currently undergoing Phase IIb testing in 120 patients for organic erectile dysfunction.

For further information about Initiator Pharma, please contact:

Claus Elsborg Olesen, CEO

Phone: +45 6126 0035

E-mail: ceo@initiatorpharma.com

About Initiator Pharma

Initiator Pharma is a clinical-stage biotechnology company based in Aarhus, Denmark. The company’s main clinical Phase assets are IPED2015, intended for patients with erectile dysfunction, and IP2018, for the treatment of psychogenic erectile dysfunction. The treatments both represent First in Class treatments for psychogenic and organic ED, respectively, and are 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. Recently, Initiator Pharma have also announced its plans to expand the clinical development pipeline to include a new program for Neuropathic Pain, more specifically the Orphan indication Trigeminal Neuralgia. Read more on www.initiatorpharma.com.

About neuropathic pain and trigeminal neuralgia

IP2015 targets the orphan neuropathic pain indication trigeminal neuralgia, a rare disease with a prevalence of 10-20 per 100,000. Trigeminal neuralgia is a deliberating orofacial pain condition characterized by sudden onset of an extreme, short-duration yet debilitating pain, often referred to as suicidal pain. There is only one FDA-approved pharmalogical treatment for trigeminal neuralgia available, Carbamazepine, which only provides limited pain relief and is associated with a significant number of side effects. Therefore, the unmet need for a new efficacious, tolerable, and safe treatment is exceptionally high. Our ambition is to develop a First-Line treatment for these patients.