From Interim Report January – March 2024
August 23, 2024
I am pleased to share an update on Initiator Pharma’s progress during the second quarter of 2024, a period marked by strategic advancements in our ongoing efforts to address unmet medical needs in erectile dysfunction (ED) and beyond.
One of the key highlights of this quarter was the publication of our international patent application WO2024/146892 regarding the dosage regime for our leading drug candidate pudafensine in the treatment of ED. This patent application represents a crucial step in our vigorous patent strategy to protect the innovative therapies we are developing. Even though it does not equate to a full clinical efficacy report, the patent application is very important as it provides a strong foundation for pudafensine, extending its protection until 2044 with possibilities for further extension. This multi-layered patent portfolio is vital as we continue to explore pudafensine’s potential as a standalone therapy or in combination with existing treatments to enhance efficacy due to its unique mechanism of action.
However, our main focus remains on patients with moderate to severe ED – a difficult-to-treat patient group that often finds current treatments inadequate. The statistically significant and clinically relevant efficacy Phase IIb data we presented last fall for pudafensine in organic ED, underscore its potential to address this unmet need. The clear efficacy results in moderate and severe ED provide strong support for pudafensine’s further development towards market authorization. The further clinical development program also includes an optimized solid oral dosage form, for which we obtained positive data in 2023 demonstrating that the oral solid dosing formulations provide relevant drug bioavailability and pharmacokinetic drug release profiles.
During the quarter, we were also thrilled to announce the publication of our preclinical pharmacology results in the prestigious British Journal of Pharmacology. This publication validates the mechanism of action of pudafensine and strengthens our confidence in its potential as a novel treatment for patients who do not respond adequately to or tolerate existing drugs. The unique ability of pudafensine to increase central dopamine and peripheral nitric oxide release offers a new pathway for initiating and maintaining erection, setting it apart from current PDE5 inhibitors.
The application of pudafensine in the clinical phase IIb study positively affected the primary parameters used to evaluate erectile function, the international index of erectile function (IIEF-15). The study lasted 4 weeks, with one dose administered each week, and the effect of pudafensine was more pronounced with time. Phase III studies are typically longer, lasting 12 weeks; therefore, we are excited to anticipate that pudafensine will have an even more significant effect in forthcoming studies of larger duration. Phase III studies are required for the registration and marketing of pudafensine for the treatment of erectile dysfunction.
Erectile dysfunction is a significant medical condition affecting millions of men’s lives globally. Our goal in advancing pudafensine for the treatment of ED is to provide an effective, well-tolerated therapy that can make a meaningful difference in patients’ lives.
From a business development perspective, we are encouraged by the ongoing interest in our Sexual Health Franchise from both regional and global partners. The growing interest in the Female Sexual Dysfunction (FSD) space, combined with the strong data we continue to generate with our assets in this area, position us well for potential collaborations that can further accelerate our growth and expand our reach.
As we move forward, we remain steadfast in our commitment to advancing our pipeline with the same rigour and dedication that has brought us to this point. I sincerely thank our shareholders, partners, employees, and the entire Initiator Pharma community for their continued support. Together, we are making significant strides towards transforming the treatment landscape for sexual dysfunction and beyond, reassuring stakeholders of our unwavering dedication.
Copenhagen, August 23, 2024
Claus Elsborg Olesen
CEO