ErgoNex Pharma is a bit of an elusive one. The company is independently financed by private Swiss money and has rights to a dopamine agonist licensed from Nihon Schering (basically Bayer’s JP operation). The website doesn’t say much about management or the company, but here’s what we know about the lead program:

• Terguride (aka Teluron), oral partial dopamine agonist, 5 HT2B and 5HT-2A antagonist;

• Approved in Japan for 10+ years for hyperprolactinemic pituitary adenoma, ovulation disorders due to hyperprolactinemia, galactorrhea and suppression of puerperal lactation;

• Long safety history profile although limited if no US use/experience (?IND);

• Demonstrated potent anti-proliferative and anti-fibrotic activity reversing remodelling processes in pulmonary arterial hypertension (PAH) and various fibrotic disorders, both of which are partially mediated by 5HT signaling;

• Trial status: PAH trial began in January 2008 in Switzerland, Germany, Austria, Poland and The Netherlands. 12-week, randomized, double-blind, placebo-controlled, 84 patients on stable treatment, PAH functional class II to IV. Primary endpoint: terguride compared to best supportive care on pulmonary artery vascular resistance. No further updates known. Apparently there is also a fibromyalgia trial ongoing;

• Misc: FDA and EMEA Orphan Designation and for PAH;

The key factors here (other than if this thing works for PAH) are whether there is a comprehensive enough regulatory package to get things started in the US and what sort of registration trial (time and cost too) ErgoNex needs to reach the finish line. We’re also a little concerned with the long term 5HT exposure, but given the severity of the PAH patients and if the treatment is not long term, Terguride might face less heat from regulators, and investors.

Management

• Rudolf Reiter – CEO

Investors

• Undisclosed

Anonymous Tip? Comments? Contact us: hr AT iguanabio DOT com

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