A plant-derived compound with a novel mechanism, eight weeks of effect from three days of dosing, and a Phase 2A readout that challenges what treatment of erectile dysfunction actually means
For decades, erectile dysfunction pharmacology has been a variation on a single theme: PDE5 inhibitors. Different brands, different half-lives, same mechanism — and the same 35 to 50 percent of patients who don’t respond to any of them. Dicot Pharma, a Swedish biotech listed on the stock exchange, is developing LIB-01, a compound derived from a plant used in traditional folk medicine, rebuilt as a patentable analog molecule that acts on the melanocortin system — specifically the MC4 receptor, a known regulator of sexual and metabolic function. What makes the clinical story unusual is the dosing profile: three consecutive days of oral treatment, followed by effects that sustained for up to eight weeks in the company’s Phase 2A proof-of-concept trial. CEO Elin Trampe — a commercial executive by background, not a scientist — spoke with Vanguard about what the Phase 2A data actually showed, how the company is financing development through retail shareholders in a tight capital environment, and why she believes LIB01 has a credible path to first-line status.
Moe: Why target the melanocortin system rather than build a better PDE5 inhibitor?
Elin Trampe: The standard of care right now is PDE5 inhibitors, and they’re all the same substance class — just different variants. If you don’t get the desired effect from them, there’s not much else to offer. So it’s important to come with a new, innovative compound with a new mechanism that has the potential to treat the current non-responders, but also address the shortcomings with current treatments.
Revealing the mechanism of action has been a very exciting journey. Starting from the folk medicine, you wonder: how can we see this long-lasting effect on erectile function lasting several weeks? It was quite recently that we got results from the pre-clinical study showing that the melanocortin system is involved — that’s a known biological pathway — and that we are impacting the signaling of a receptor called MC4, which is known for regulating sexual function and metabolic functions. The novel mechanism is really the most important aspect here, because it has the potential to address both the shortcomings with current treatments and to help the current non-responders.
Moe: How did Dicot manage to patent a compound rooted in folk medicine?
Elin: What’s very important to understand is that the founder of Dicot Pharma managed to isolate the compound that’s active in the folk medicine use and develop an analog molecule. So we have been able to patent the molecule itself and the manufacturing methods to produce it, along with everything else around drug development that is patentable.
Moe: How does the dosing regimen work, and why does the effect last so long?
Elin: It’s an oral treatment — a pill will be used in phase 2b. The regimen is that you take the pill for three consecutive days, one each day, and then the effect starts and lasts for several weeks. What we saw from the Phase 2A trial, the proof-of-concept study, was that the effect not only lasted for four weeks but actually sustained for eight weeks after initial dosing.
In terms of the mechanism, if you look at PDE5 inhibitors, they act more locally in the erectile tissue. LIB-01 acts on the underlying mechanisms for erectile function — the vascular and nervous structures that interact in penile erection. We’ve seen that LIB-01 affects those nerves and vascular structures, and that the melanocortin system is involved. The receptor I mentioned is known for managing nerve signaling between the brain and spinal cord.
“*”With our drug, it seems that you can normalize your sexual activity. That is one thing that was demonstrated — the long-lasting effect.”*”
Moe: How does that translate to quality of life beyond the physical?
Elin: Today, if you need to plan your sexual activity — take a pill half an hour or an hour before — that takes away the spontaneity. There’s a lot of anxiety: shall I take this pill now? You’re constantly reminded of your issues. With our drug, it seems that you can normalize your sexual activity.
And I think erectile function has recently started to be highlighted within the field of longevity, because it’s not only about the sex life — it’s so much more in terms of quality of life: anxiety, sleep quality, work productivity. It has many aspects and negative consequences. So yes, the quality-of-life dimension goes well beyond the physical.
Moe: How are you positioning this commercially — as a treatment for non-responders, or something broader?
Elin: A new first-line treatment. Definitely.
The drawbacks with current medication that we are addressing are: first, the non-responders — some medical experts say that’s as high as 50% of patients, and a novel mechanism is required for them. Second, people stop using current treatments due to disturbing side effects. Third, the requirement of planning, which takes away spontaneity. We are addressing all of these shortcomings. We also get that feedback when talking to KOLs around the globe — that this is really promising and could actually revolutionize the market.
Moe: Why does the IIEF scale matter for your regulatory strategy?
Elin: The IIEF — the International Index of Erectile Function — is the mandatory tool from a regulatory authority point of view. It’s the established way to measure erectile dysfunction in a clinical setting and in clinical trials. It’s a self-questionnaire: as a participant, you respond to a range of questions to assess your erectile function. That is what we have used, and it’s what the authorities expect.
Moe: How does a commercially-oriented CEO navigate the scientific scrutiny that comes from regulators?
Elin: It’s very much a team effort. You need a very good team with all the necessary competencies. We have a chief scientific officer who is the main point of contact toward regulatory authorities and clinicians. The management team is very experienced. My role as CEO is more about ensuring that the commercial strategy, the clinical strategy, the regulatory strategy, and the IP strategy all fit together — that they’re speaking the same language and working toward the same positioning in the market. It comes down to having good people.
Moe: Why has retail investor financing worked for Dicot when institutional capital is so constrained?
Elin: We’ve had a very strong track record in terms of financing so far. We’re listed on a Swedish stock market, Nasdaq First North, and have financed drug development through rights issues to our shareholders. The last time we did one, it was actually oversubscribed — we received more money than we asked for. I think that also demonstrates the interest.
Erectile dysfunction is an indication that is quite easy to relate to for anyone. You don’t have to experience the issue yourself. And I also think our track record of delivering according to communicated timelines and consistently advancing the program has been important to shareholders — that we are really delivering on what we say we will.
Erectile function has recently started to be highlighted within the field of longevity — it’s not only about the sex life. It’s so much more in terms of quality of life: anxiety, sleep quality, work productivity – Elin Trampe, CEO, Dicot Pharma
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
