In
“I am excited to be in
The commercial potential within the FSD area is considered to be very attractive. The total female sexual dysfunction treatment market size is expected to grow by
“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. 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,” concluded
About FSD and the position intended for
Female sexual dysfunction (FSD) includes a range of issues such as hypo-sexual desire disorder (low libido), difficulty achieving arousal, pain during intercourse, and inability to reach orgasm. Female hypo-sexual desire disorder (HSDD) in the US occurs in 10% of women, independent of age. FSD can profoundly affect the individual's quality of life and relationships due to the distress, low self-esteem, and anxiety it causes. There are medical treatment options for young women with FSD, but despite the current options, a large unmet need is to restore the desire for an intimate relationship with the partner.
Pudafensine and IP2018 offer the potential as first-line treatment options in postmenopausal generalized, acquired HSDD – where it would be positioned as the first approved therapy. Both products offer the potential of clear differentiation from current FSD drugs, with the key differentiators:
- Non-hormonal mechanism of action
- Clean safety/tolerability, no drug interaction or contraindication issues (as shown in completed trials in men with Erectile Dysfunction)
- Convenient, oral, on-demand dosing
- Potentially improved efficacy to Addyi and Vyleesi (currently only approved for use in HSDD in premenopausal women)
About pudafensine and IP2018
Pudafensine (IP2015) is a monoamine reuptake inhibitor that preferentially inhibits the synaptic reuptake of dopamine followed by serotonin. Pudafensine is a candidate drug for patients with Erectile Dysfunction (ED) and pain indications. The treatment is expected to improve the quality of life for many patients who are not responding to or cannot be treated with existing drugs on the market. The Phase IIb study on patients with ED of organic origin was completed in
IP2018 is a monoamine reuptake inhibitor that inhibits the synaptic reuptake of serotonin, dopamine, and noradrenaline. IP2018 preferentially inhibits serotonin followed by dopamine reuptake, while it has markedly less effect on the noradrenaline reuptake. In animal models for depression and ED, IP2018 has shown both an anti-depressive effect and positive effects on erectile function. In Q2, 2023, positive results were reported in a Phase IIa study in patients with depression and ED.
© Modular Finance, source