Intervju med Claus Olesen, VD på Initiator Pharma

Initiator Pharma genomför just nu en företrädesemission som löper till den 26 juni. I samband med detta intervjuar vi VD Claus Olesen som berättar om bolagets kliniska framsteg, satsningen inom kvinnohälsa och varför pudafensine kan bli en viktig pusselbit inom både smärta och sexuell dysfunktion. Intervjun är på engelska, men du hittar även en svensk översättning nedan.

Initiator Pharma is a clinical-stage pharma company that develops a family of drug candidates based on monoamine reuptake inhibitors for unmet medical needs within the central and peripheral nervous system. Our key therapeutic area is erectile dysfunction (ED). We have recently expanded into new areas including pain and female sexual dysfunction (FSD).

Our lead candidate, pudafensine, has demonstrated efficacy in treating erectile dysfunction in a phase IIb trial, and has also shown potential for treating neuropatic pain. The properties of pudafensine are applicable both in men and women and we have broadened the scope for pudafensine to also include treatment of female sexual dysfunction and pain conditions in women such as vulvodynia.

Our current development portfolio contains two clinical stage assets; pudafensine and IP2018. Three projects are in clinical development phase. 

• Pudafensine in organic ED - in the fall 2023 we reported positive, statistically significant and clinically relevant efficacy results in a 130 patient Phase IIb
  trial with pudafensine in Erectile Dysfunction (ED) of organic origin. Next step currently is to expand the monotherapy with a combination of pudafensine with PDE5-inhibitors (e.g. Viagra or Cialis) in erectile dysfunction.
• IP2018 in psychogenic ED - in the summer 2023 we reported positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic ED in a Phase IIa clinical trial in 24 patients with mild to moderate ED.
• Pudafensine in vulvodynia - a Phase 2a clinical proof-of-concept study is planned to start in H2 2025, evaluating pudafensine as a potential treatment for vulvodynia. The study will be a randomized, placebo-controlled, four-way crossover trial in 24 women with vulvodynia, assessing the pain-relieving effects and safety of single oral doses of pudafensine. The study will be conducted with MAC Clinical Research Unit in the UK, and is expected to conclude by end 2026.

Vulvodynia is a severe chronic pain condition that affects the vulvar area and occurs without an identifiable cause. The condition affects approximately 10 percent of all women worldwide and there is currently no approved treatment available.

There is a strong rationale for our clinical asset pudafensine in vulvodynia, as it addresses both pain and sexual dysfunction — the two most debilitating aspects of the condition. Backed by promising efficacy already demonstrated in a healthy volunteer pain challenge study, we see pudafensine as a potential first-in-class treatment for vulvodynia.

Considering the vast unmet need and the number of women affected, the potential market opportunity for an effective approved drug is expected to be significant.

In the short to mid term our clinical goals are to initiate the planned Phase 2a study in vulvodynia, assessing the pain-relieving effects and safety of pudafensine in 24 women diagnosed with vulvodynia. The study will be conducted with MAC Clinical Research Unit in the UK, targeting a start in the fall of 2025 and is expected to conclude by end 2026.

On a corporate level we are continuing to explore new strategic collaborations that can accelerate our progress and expand our global reach. We are encouraged by the strong and growing interest we see from the industry and academia, and our business development efforts remain at high pace. 

The proceeds from the Rights Issue are expected to finance Initiator well into 2027. We intend to use the net proceeds for the following purposes, listed in order of priority:

• Clinical trial in vulvodynia and related costs
• Additional pre-clinical studies and other activities relating to pudafensine in other indications
• Activities relating to combining pudafensine with PDE5-inhibitors in erectile dysfunction
• Business development activities relating to pudafensine
• General corporate purposes
   

With the proceeds raised from the rights issue, together with the recent financing agreement with MAC, Initiator will be able to complete the planned clinical trial in vulvodynia that has the potential to significantly increase the value of pudafensine. If we can demonstrate efficacy in vulvodynia, it will open up significant potential within women’s health, a segment where there are few available treatments and significant unmet medical need.

To me, this represents a truly unique opportunity. We have a proven product and a broadened offering that we believe holds strong potential — whether through a major deal with one global pharmaceutical company or several agreements with regional players. Expanding the offering not only increases the number of potential partners at the negotiation table but also strengthens our overall negotiating position.