Dicot Pharma is developing LIB-01 as an entirely new treatment concept for erectile dysfunction. The three abstracts presented at SMSNA included results on LIB-01’s mechanism of action, the phase 2a clinical study and the design of the planned phase 2b study. SMSNA is considered the leading organization in North America for the advancement of and education in sexual medicine.

The presentations were delivered by Dicot Pharma’s Chief Scientific Officer, Dr. Charlotta Gauffin, and two internationally recognized experts in sexual medicine: Dr. Harin Padma-Nathan, formerly a principal investigator for Viagra and Cialis in the United States and previously a professor of urology at the University of Southern California; and Dr. Arthur Burnett, Professor of Urology at the Johns Hopkins School of Medicine, Patrick C. Walsh Distinguished Professor of Urology, and internationally recognized for his contribution to elucidating Viagra’s mechanism of action.

“The SMSNA brought together the leading North American authorities in ED pharmacotherapy, many of whom were investigators in the Viagra clinical development program. To a person, they were enthused by the LIB-01 preclinical and clinical data. LIB-01 was described as demonstrating an ideal profile for an oral ED therapy with respect to efficacy, safety and long duration of action, providing normalization of erectile function and facilitating natural spontaneity. I could not agree more”, says Dr. Harin Padma-Nathan.

“LIB-01 is a remarkable drug candidate that has been shown in early research trials to produce erection responses effectively and sustainably after short-term delivery. It has the potential to revolutionize the clinical management of erectile dysfunction and it is encouraging that LIB-01 generated such great interest at the conference”, comments Dr. Arthur Burnett.

“There is a significant need for new treatments in this field, where no major innovation has reached the market in the past 28 years. LIB-01 addresses this need through its novel mechanism of action and long-lasting effect. The positive response at the conference is a clear indication of LIB-01’s potential to transform the treatment of erectile dysfunction”, says Elin Trampe, CEO of Dicot Pharma.

Today, Dicot Pharma will host an investor presentation to share the content of these abstracts with the market. Please note: some parts will be presented only in Swedish. The webcast is open to everyone via this link and also on the company website and can also be viewed later.

Below is a summary of the most important conclusions in the abstract that was presented under the section "Innovations in Sexual Medicine Abstracts":

LIB-01: Part I - Durable Pro-Erectile Effects Involving Transcriptional Modulation of the Melanocortin System

• LIB-01 indirectly potentiates the melanocortin system by increasing MC4R signaling capacity and amplifying physiological response when the pathway is naturally engaged.
• LIB-01 is not an MC4R agonist.
• LIB-01 produces a long-lasting pro-erectile effect following short-term drug exposure, defining a mode of action that is fundamentally different from existing ED therapies.

LIB-01: Part II - A Novel First-in-Class Oral Investigational Therapy for Erectile Dysfunction with Demonstrated Clinically Meaningful Improvements in Erectile Function and Duration of Action up to 8 Weeks

• Following an initial 3-day dosing only, LIB‑01 at 25 and 50 mg, delivered clinically meaningful, dose‑dependent, and long-lasting improvements in erectile function for at least 8 weeks, with peak effects observed during the first 4 weeks.
• LIB-01 was well tolerated.
• The long duration of action may alter the paradigm of oral ED therapy, with the potential to facilitate spontaneous sexual encounters and intimacy, rather than transient enhancement of erectile function.
• The results of this study informed the construct of the Phase 2b study design.

LIB-01: Part III - A Phase 2b Trial Design Adapted to a Molecule with a Novel Mechanism and Durable Pharmacodynamic Profile

• Include all ED severity groups to reflect real world clinical practice, enriched in moderate ED (70%).
• Monthly dosing aligned with durable therapeutic effects.
• Include 25 mg, 50 mg, and a higher dose.
• Stratification by baseline NLR (neutrophil-to-lymphocyte ratio), based on post hoc analyses indicating that higher NLR was associated with reduced placebo response, whereas treatment response to LIB‑01 was less influenced.
• Primary endpoint, change from baseline in IIEF-EF score at week 12
• Adaptive design with prospectively planned study refinement.
• Phase 2b is tailored to the distinct pharmacology and response profile of LIB-01.