Swedish pharmaceutical company Dicot Pharma announced that all participants in its Phase 2a clinical trial evaluating LIB-01 for erectile dysfunction have been dosed, marking a significant milestone in the development of what could become a new first-line treatment for the condition. The study is expected to complete in August 2025, with results reported within three months thereafter.
The completion of enrollment represents an accelerated timeline for the Uppsala-based company, which managed to fully recruit and dose participants in just nine months. "We are very pleased to be able to complete this study in just nine months. It's a strong endorsement of Clinical Trial Consultants, the CRO we're working with," said Charlotta Gauffin, Chief Scientific Officer at Dicot Pharma.
Novel Mechanism Targets Neurological Pathways
LIB-01 represents a potential paradigm shift in erectile dysfunction treatment through its unique mechanism of action. Recent studies revealed that the drug candidate affects nerves and vascular structures that interact in creating penile erection, differentiating it from currently available potency drugs. This novel approach may explain LIB-01's potentially long-lasting effects and could address limitations of existing therapies.
The mechanism of action findings emphasize the drug's differentiation from current erectile dysfunction treatments, potentially offering patients a new therapeutic option with improved efficacy and tolerability profiles.
Comprehensive Clinical Trial Design
The Phase 2a study enrolled 140 men with erectile dysfunction across six clinical sites in Sweden (Uppsala, Stockholm, Gothenburg, and Linköping), Denmark (Herlev), and the Netherlands (Groningen). All participants were required to be in steady relationships for at least six months prior to enrollment.
The trial follows a double-blind, placebo-controlled design where neither clinical staff nor participants know which subjects receive LIB-01 versus placebo. Each participant undergoes an eight-week study period following dosing, with efficacy evaluated using the International Index of Erectile Function questionnaire.
Participants receive dosing for three consecutive days, followed by monitoring throughout the study period. The structured approach ensures comprehensive safety and efficacy data collection while maintaining scientific rigor.
Addressing Significant Unmet Medical Need
Erectile dysfunction affects over 500 million men globally, representing a market valued at $8 billion. Dicot Pharma's business model focuses on evaluating industrial and financial partnerships during clinical development to facilitate global commercialization of LIB-01.
The company's development strategy aims to create a drug with significantly longer effects and fewer side effects compared to currently available treatments. This approach could address key limitations patients experience with existing erectile dysfunction therapies.
Strong Financial Position Supports Development
Dicot Pharma recently strengthened its financial position through successful warrant exercises, with TO 6 warrants subscribed at 96%, providing approximately SEK 43.8 million before issue costs. Major shareholders, board members, and management demonstrated confidence by committing approximately SEK 11 million, representing about 24% of total outstanding warrants.
The company has also secured comprehensive patent protection, with the entire patent family reaching approval in the United States with protection extending until 2042. This intellectual property portfolio significantly strengthens both product and method protection for LIB-01.
Clinical Development Momentum
The Phase 2a trial initiation followed successful completion of Phase 1 studies, with results presented at the European Society for Sexual Medicine (ESSM) annual congress. Professor François Giuliano, a urologist and specialist in male sexual health, delivered presentations on the Phase 1 findings and Phase 2a study design at the conference.
Dicot Pharma has appointed international business development expert Håkan Wickholm as Chief Business Officer to intensify focus on future commercialization. Wickholm brings extensive global experience from business development roles at AstraZeneca, including Regional Business Development Director for Europe and the Middle East.
The company transitioned from Spotlight Stock Market to Nasdaq First North in November 2024, expanding its shareholder base from 7 to approximately 10,100 shareholders. This listing change is expected to benefit continued development, internationalization, and competitiveness while strengthening company awareness.
