Innovation & Business Idea
The company's lead asset (AN346) is a novel small molecule KCa3.1 channel blocker which has demonstrated significant anti-inflammatory effect in vivo, while not causing any severe adverse effects in a 2-week tox study. However, due to low oral bioavailability AN346 is not suitable for systemic treatment, and focus is now to develop it for local treatment in ophthalmology. The development strategy is to demonstrate the anti-inflammatory effect in humans as fast and cost-efficient as possible, and in discussions with leading experts’ non-infectious anterior uveitis is the choice of indication for the first-in-man trial.
Customers / Target Market
Isanans is currently focusing activities in ophthalmology and the clinical development strategy is as quickly, cheaply and predictable as possible to demonstrate AN346’s anti-inflammatory effect in the human eye. For this purpose, non-infectious uveitis (NIU) has been identified as the clinical PoC indication, but if the product proves effective in NIU it will hold potential far beyond this indication only for instance in corneal fibrosis, post-operative inflammation etc.
Main competitors for treatment of non-infectious anterior uveitis are steroids, and although these are a cheap and often effective treatment option, they come with severe side effects. The alternative, NSAIDS, have far less side effects but are not equally effective. Based on the animal data generated to date, the anticipation is that AN346 could be a safe and effective alternative to steriods for patients in need for chronic treatment.
The drug of choice for the prevention of haze formation after surgical insult is currently mitomycin C and although it has proven effective in some patients, it comes with some safety concerns. Hence, a safe and effective treatment alternative would be valuable.
Intellectual Property Status
Patent issued in EU, US and JP.
Development Status & Future Steps
Significant effect has been demonstrated in an inflammatory animal model after systemic exposure, and no severe adverse effects where observed in a two-week tox study. Next steps are to complete formulation development for eye drops, test ocular tolerability after topical installation and finally to do an ocular pharmacology study to help guide in dose selection for the first-in-man trial. Upon successful completion of these, GMP production and tox studies will be initiated allowing for conducting the FIM trial. Data from the FIM trial is expected within 2-2.5 years from funding.
A successful completion of the first-in-man trial will be a major value inflection point and a potential exit opportunity.
Kamilla Rolsted, PhD, MBA; Co-founder and CEO.
A life science executive with experience from scientific, business development and leadership roles from publicly traded companies. Kamilla has been responsible for leading and defining the strategic direction and has participated in securing dilutive and non-dilutive capital.
Morten Albrecthsen, MD; Co-founder.
A seasoned life sciences entrepreneur with a strong medical, commercial, and financial background. Morten started his first company in the early 1980s and was previously CEO and founder of Nanovi and ENKAM Pharamceuticals among others. Morten has is currently CEO of FluoGuide and Chairman of RetiPharma (focused on developing novel treatments for neurodegenerative eye diseases).
Besides the two co-founders, a team of scientific experts within ophthalmology, ion channels and pharmacology/immunology are being consulted as part of defining the development path.
Isanans is seeking €3 M to prepare for and complete the first-in-man trial in non-infectious anterior uveitis patients.
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