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PropThink: Amicus Moving on Phase II Data, Interest Ahead of Phase III Release in 4Q


By Jake King

Trading in Amicus Therapeutics (NASDAQ: FOLD) picked up considerably in the last few days, driving the stock up 19% to a high of $6.15 on Tuesday before the rally pulled back to more conservative levels around $5.70. On Thursday, however, FOLD is up 5% following the release of preliminary data from an ongoing Phase II Trial of AT2220 in the treatment of Pompe Disease.

The data do look positive so far for Study 010, which is examining safety and plasma pharmacokinetic effects of the pharmacological chaperone AT2220 when administered with standard enzyme replacement therapies (ERT) Myozyme and Lumizyme. These ERTs, marketed by Sanofi's (NYSE: SNY) Genzyme, are the only approved treatments for Pompe disease, and Amicus believes that AT2220 has the potential to improve rhGAA enzyme activity and possibly mitigate immunogenicity related to enzyme replacement therapy. So far, the trial is demonstrating increased Pompe enzyme (rhGAA) activity in the first three dosed cohorts, each of which received a higher dose than the previous. An independent data safety monitoring board has reviewed the ongoing trial and determined that the final cohort, which will receive the highest AT2220 dose yet, may continue; Amicus expects the most impressive results from this cohort. The drug has been well-tolerated and demonstrated no related adverse events thus far.

Amicus volume picked up earlier this week, however, not in anticipation of the Phase II data but due to increased editorial coverage and excitement over an upcoming data release for the company's lead candidate, AT1001. The drug is a treatment for the lysosomal storage disorder Fabry Disease, which affects less than 10,000 people worldwide. A six-month primary treatment period in Study 011 finished up in the second quarter, and data from the study period is expected in the fourth quarter when the trial's six-month follow-on period finishes as well. AT1001 is partnered with Amicus' major shareholder, GlaxoSmithKline (NYSE: GSK). If interest and trading volume continue, Amicus will likely see a run-up into the anticipated Phase III data.

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