• In July the company announced that it has obtained positive data from a Phase I drug formulation and pharmacokinetics study in healthy subjects evaluating optimized oral solid dosage forms of pudafensine (IP2015), enabling a smooth and efficient bridging between previous data sets into new future clinical studies for pudafensine.
• In August the company announced that the European Patent Office (“EPO”) has granted the company’s patent application for the product candidate IP2018, targeting monoamine reuptake transporters.
• In September the company announced that the drug candidates, pudafensine and IP2018, have shown significant efficacy in preclinical models for Female Sexual Dysfunction (FSD). Based on the findings, the company is reviewing the potential to extend the clinical indications for the drug candidates to include FSD.

Business highlights after this reporting period

• In October the company announced positive results from its Phase IIb clinical trial with pudafensine (IP2015) for the treatment of erectile dysfunction (ED). The study data analysis has demonstrated statistically significant and clinically relevant efficacy in ED-related endpoints and no observations of critical adverse events. The positive results, both regarding efficacy and safety, support further development of pudafensine aiming at registration and launch in this patient group with significant unmet medical need.

Financial Highlights

Solidity: equity divided by assets.

The Board of Directors have decided that interim reports will be published in English only.

Link to the full report
https://www.initiatorpharma.com/en/investors/reports-and-presentations/