From Year-end Report 2023
The last quarter ended a very busy and successful 2023 for Initiator Pharma, where we have achieved multiple important milestones across our development pipeline. All of our programs have made significant progress, with the reported positive, statistically significant, and clinically relevant, efficacy Phase IIb data in erectile dysfunction (ED) with pudafensine as the standout achievement during year. The results highlight the potential of pudafensine as a novel treatment for patients who do not respond to or do not tolerate the currently marketed drugs.
Statistically significant and clinically relevant Phase IIb pudafensine efficacy data in organic ED reported in October
Our leading drug candidate is developed for patients with ED and pain indications. The aim of pudafensine within ED is to improve the quality of life for a large number of patients who do not respond to or cannot be treated with currently marketed drugs. There is a massive medical need for more effective treatments, with about 400 million men worldwide expected to be suffering from ED. Of these, 30-40 percent will not respond to the currently available treatments. It was therefore with great satisfaction that we in October reported positive study data from the Phase IIb clinical trial with pudafensine. This study demonstrated statistically significant and clinically relevant efficacy in ED-related endpoints with no observations of critical adverse events.
The primary objective of the completed Phase IIb study, which was completed in July 2023, was to investigate the effects of pudafensine and placebo in 130 male patients with moderate or severe erectile dysfunction on the ability to develop and maintain an erection. The unique study design allowed the patients with moderate to severe ED to observe the effect of pudafesnine in the home environment, and the evaluation of the sexual parameters of relevance for a future drug approval by the regulatory authorities. The clear efficacy results in moderate and severe ED provide support for pudafensine’s further development towards market authorization.
Optimized solid dosage forms of pudafensine
Initiator is also developing a novel solid oral dosage form of pudafensine, which has been evaluated in a Phase I pharmacokinetic study in 12 healthy subjects. In the summer of 2023 we obtained positive data demonstrating that the oral solid dosing formulations provide relevant drug bioavailability and pharmacokinetic drug release profiles supporting the future treatment settings in Phase II and III trials. This optimized solid oral dosage form supports an attractive product profile for pudafensine and represents an important milestone in preparation for future pivotal registration trials.
Positive, dose-dependent, significant efficacy data in psychogenic ED reported for IP2018
The monoamine reuptake inhibitor IP2018 differs from our front- runner pudafensine as it, due to its unique profile, targets patients suffering from mild depression or low mood and ED. The goal is to position IP2018 as a treatment for patients suffering from depression and sexual dysfunction. It is estimated that up to 68% of patients with major depressive disorder also suffer from sexual dysfunction, for which only 5% to 30% is resolved with antidepressant treatment. With that in mind we were very pleased, in the summer of 2023, to announce positive, statistically significant, and dose-dependent clinical observations related to efficacy in our Phase IIa clinical trial with IP2018 in 24 mildly depressed or low mood, erectile dysfunction patients. This was the first time we treated patients with depression, mood disorder, and erectile dysfunction. During the year, we have also extended the IP protection for IP2018 in Europe, concerning the treatment of ED and depression, and thereby strengthened the exclusivity for our drug pipeline.
Sexual Health Franchise sets new direction
Based on promising preclinical data, where our drug candidates pudafensine and IP2018, have showed significant efficacy also in models for Female Sexual Dysfunction (FSD) we conducted a comprehensive strategic review of the FSD opportunity during the fourth quarter. With the conclusions from the review, including a full commercial assessment, and the promising data obtained in the preclinical models, the management and board of directors decided to build on the strong data obtained from both our Phase II clinical studies with pudafensine and IP2018 and expand the position to a broader Sexual Health Franchise including both ED and FSD indications.
Female Sexual Dysfunction is a major opportunity
The broader sexual dysfunction effort will capture the FSD opportunity in a de-risked way and offers a great life cycle management opportunity with significant revenue and earnings potential. FSD includes a range of issues, such as hypoactive sexual desire disorder (HSDD, low libido), difficulty achieving arousal, pain during intercourse, and inability to reach orgasm. FSD can profoundly affect womens quality of life and relationships. There are medical treatment options for young women with FSD, but despite the current options, a large unmet need remains in restoring the desire for an intimate relationship with a partner. The commercial potential within the FSD area is considered to be very attractive. An analysis of the commercial assessment has concluded that a product for underserved women suffering from FSD/HSDD should have potential to reach peak sales of at least USD 2 billion. Initiator Pharma is initially exploring the opportunity with a priority on postmenopausal women with FSD, where there currently is no available treatment option. Both Pudafensine and IP2018 could offer the potential as first-line treatment options in the targeted market segments. Besides the apparent opportunity ahead within sexual dysfunction we maintain an interest in developing assets of relevance in severe neuropathic pain. We have previously executed a study in healthy volunteers with pudafensine, showing very encouraging data and supporting an effort within neuropathic pain. Our team has unique experience and skills which we are keen to harness and optimize in order to best capitalize on the possibilities in treating this underserved market segment with significant unmet medical needs and we expect to provide further details on this effort and the unique possibilities relating to a program in pain during 2024.
MAC Clinical Research new shareholder in Initiator Pharma
February 2024, we could welcome MAC Clinical Research (MAC) as a new shareholder in the company. The background is the convertible loan agreement that was an important part of the financing of the pudafensine clinical Phase IIb study, which was carried out by MAC. The agreement gave MAC the right to convert the credit into Initiator shares up to approximately 23 MSEK at a share price of 7.5 SEK, equivalent to a premium of more than 70 percent compared to the share price at the day of signing the agreement, upon the full completion of the pudafensine Phase IIb study. MAC is av very trusted and important partner for Initiator Pharma and Mark Dale, MAC’s CEO, has expressed that MAC looks forward to being a part of Initiator Pharma’s promising future journey in the years ahead. We are glad to have MAC aboard as a shareholder.
Intensified business development efforts and funding into 2025
To optimize shareholder value, and with the strong support from our existing shareholders seeing the great potential in our assets, the discussions and negotiations with potential partners are of highest priority during 2024. We presented our new direction at business and investor meetings in connection with the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco. With our extended opportunity, together with recent statistically significant and clinically relevant data from two strong drug candidates, the interest from potential partners was considerable.
I am also pleased to confirm that with the current priorities set, we have enough funding well into 2025 and no significant need to invest further in pudafensine or IP2018 during 2024.
Thank you for following Initiator Pharma.
Copenhagen, February 23, 2024
Claus Elsborg Olesen
CEO