Finland's Forendo Attracts Big Pharma For Liver Disease R&D
Deal To Boost Novartis's Liver Disease Efforts
Executive Summary
Turku, Finland-based Forendo Pharma has entered into a license and collaboration deal with Novartis involving the identification of novel drugs to treat chronic liver diseases.
Finland’s Forendo Pharma Ltd. is to collaborate with Novartis AG on identifying novel drug candidates for the treatment of chronic liver diseases, in what appears to be the first big pharma deal for the northern European clinical-stage drug development company.
The collaboration will make financing its own clinical programs "quite a bit easier,” remarked Forendo CEO Risto Lammintausta. These programs comprise a product candidate for endometriosis which is progressing into Phase II, and the start of Phase I next year with a product for polycystic ovary disease. “We are also carefully evaluating other opportunities,” added Lammintausta.
The Forendo executive believes the next 12 months might also see a series B round for Forendo, which was set up in 2013 and is supported by corporate and institutional VC firms, including Novo Seeds, Karolinska Development, Innovestor, Novartis Venture Fund, M Ventures, Vesalius Biocapital III Partners and Sunstone Life Science Ventures.
Forendo was Sunstone’s first investment from its new Fund IV, which had its first closing at €80m earlier this year.
Key Area For Novartis
The collaboration is also significant for Novartis, which has previously invested in Forendo through its VC arm, Novartis Venture Fund, and has a significant research effort underway in liver disease, including a potential best-in-class, non-bile acid farnesoid X receptor agonist, tropifexor, which has shown promise in a Phase IIb study, and may become a backbone therapy in non-alcoholic steatohepatitis (NASH). (Also see "Novartis, Pfizer Advance Their NASH Ambitions Separately, As Partners" - Scrip, 13 Nov, 2019.)
Not content with buying The Medicines Co. to bolster its cardiovascular franchise, Novartis has also been active in using business development to supplement its research activities in liver disease. Over the past 12 months, the Basle, Switzerland-based big pharma has paid $310m to buy inflammasome-focused IFM Tre, and paid $80m to license a preclinical integrin inhibitor discovered by Pliant Therapeutics Inc.. (Also see "Novartis Adds To NASH Pipeline By Licensing Pliant’s Integrin Inhibitor" - Scrip, 23 Oct, 2019.)
That said, Novartis’s collaboration with Forendo is at an earlier research stage. The Turku, Finland-based Forendo will use its expertise in discovering and developing inhibitors of the 17-beta hydroxysteroid dehydrogenase (HSD17B) enzyme family to find compounds which may be useful in treating chronic liver diseases.
Novartis will fund Forendo’s discovery effort in the therapeutic area, and the Swiss big pharma will make an undisclosed upfront payment and an equity investment in Forendo, and will pay development, regulatory and commercial milestones, and tiered royalties on sales.
In return, Novartis has a worldwide exclusive license to drug candidates generated under the collaboration, and will assume responsibility for development, manufacturing and commercialization.
The 17-beta hydroxysteroid dehydrogenase enzyme family regulates hormonal activity in specific tissues, and inhibition of enzymes active in specific tissues may be able to play a therapeutic role in a number of diseases.
The enzyme family consists of 14 iso-enzymes, some of which have activities unrelated to steroid metabolism, explained Lammintausta. Forendo’s activities build on a number of academic collaborations, such as with research groups at the University of Turku, and include its lead program, the HSD17B1 inhibitor, FOR-6219, which is targeting endometriosis and is in Phase Ib clinical studies. The enzyme inhibitor aims is to reduce estrogen production locally in the endometrial lesions.
The most important expected differentiator of FOR-6219, compared to currently available treatments, is its selective activity and the ability to act locally in the target tissues without impacting systemic hormone levels, the company notes.
A HSD17B5 inhibitor is in preclinical studies with potential to treat polycystic ovary syndrome, and a novel selective estrogen receptor modulator (SERM), fispemifene, with potential for the treatment of male urological symptoms, has been evaluated in Phase II studies.