Karo Bio fully funded for Phase III of lipid-lowering eprotirome
This article was originally published in Scrip
Karo Bio of Sweden is to raise SEK325 million (£30 million) in a rights issue to fund a Phase III programme for its lead candidate, the lipid-lowering product eprotirome. Karo Bio decided earlier this year following dialogue with the US FDA and potential partners that the development of eprotirome in a broad indication,polygenic dyslipidaemia, would necessitate "a disproportionate investment", said Karo Bio's president and CEO Fredrik Lindgren. It was then decided to develop eprotirome in a niche indication that could be developed at "reasonable investment levels".
The company has decided to pursue EU marketing approval for eprotirome for the treatment of high-risk patients with heterozygous familial hypercholesterolaemia (HeFH). It is hoped that this will lead on to "realising the full potential of eprotirome".
The narrowed programme will cost around SEK400 million. Karo Bio had already secured SEK230 million by entering into an equity credit facility with Azimuth Opportunity which it is entitled to use to successively issue shares for up to three years at 95% of the market price.
HeFH has a prevalence of around one in 500 of the population, although less than 15% of patients are diagnosed, according to Karo Bio. Those that are diagnosed are usually treated with high doses of statins and only around 30% of these reach their treatment goal, added the company.
The main feature of the Phase III programme will be clinical trials involving up to 1,150 patients treated for 12-18 months, with the primary goal of demonstrating a reduction in LDL cholesterol as an add on therapy to existing treatments. If this Phase III programme proceeds to plan, Karo Bio expects to file its approval application in Europe at the end of 2013 or in 2014.
Karo Bio has decided not to outlicense the product at this time as it believes that funding the Phase III programme alone "is a better economic option". In order to commercialise eprotirome, Mr Lindgren expects to sign distribution partnerships.
Additional trials and other development activities will be considered in the US and elsewhere "as soon as we have initiated the Phase III programme for the EU".
end of Merck collaboration?
Karo Bio's long-standing R&D alliance with Merck & Co could be at an end. The companies have been working together since 1997 in the area of women's health.
In August, Karo Bio said that Merck had decided to discontinue the last of the programmes originating through their alliance, a Phase II programme for MK-6913, which targets the oestrogen receptor, for the treatment of hot flashes. "The decision was made due to failure to achieve the predefined efficacy criteria, rather than problems with side effects," said Mr Lindgren. The largest of Karo Bio's in-house preclinical programmes also involves oestrogen receptor beta-selective agonists as potential treatments for cancer, depression and other indications.
A second preclinical programme targets glucocorticoid receptor modulators for the treatment of inflammation (in collaboration with Zydus Cadila).