3 Biotechs Recovering From Data “Blowups” Print E-mail
By Brian Wilson - Lead Contributor   
Friday, 04 October 2013 09:49
Cytokinetics (NASDAQ: CYTK) seems to have stabilized just about $7.00 weeks after the company and partner Amgen (NASDAQ: AMGN) presented data from the 613 patient, randomized, double-blind and placebo-controlled Phase II study ATOMIC HF trial at the European Society of Cardiology Congress (ESC) on September 2nd, 2013. The drug being studied in the trial, Omecamtiv Mercabil, is a drug that causes the contraction of muscles in the heart.

Although the company stated that the trial was less likely to reach its primary endpoint –reduction of dyspnea (shortness of breath), the market had a rather strong reaction to the data. After a prolonged period of weakness, the market capitalization of the company appears to be settling close to $200 MM.It’s generally understood that there is a more important data presentation coming from COSMIC-HF in the near future, although investors may stay cautious until good data is presented. On the bright side for Cytokinetics, it seems that the dosing of the drug correlates with the efficacy. At the 320 ng/mL dose, the company has a better chance of success in the next trial.

ChemoCentryx (NASDAQ: CCXI) has also settled close to $5.50 per share as the company recovers from a top-line, interim Phase II data presentation for its CCR2 inhibitor CCX140. This drug, which is being developed as a diabetic nephropathy drug, is currently performing below the company’s efficacy expectations at the current dose. Investors, who seem to currently be afraid of a problem with the company’s chemokine-based platform, are being quite unforgiving as we get closer to the company’s top-line results. This was worsened after partner GlaxoSmithKline returned commercialization rights to the Crohn’s disease drug vercirnon, which was the culprit of another data blowup weeks before CCX140.

Overall, we can say that the full data for CCX140 as a diabetic nephropathy drug will truly make or break the company and stock for the next few years. The top-line data will be available in the second half of 2014, so we will revisit ChemoCentryx as this catalyst approaches.

Neurocrine (NASDAQ: NBIX) is yet another company and stock that has recently taken damage as a result of a failed clinical trial, although Neurocrine seems to have fared better than the others after the Phase IIb results of the VMAT2 inhibitor NBI-98854. This drug is a treatment for a rare neurological disorder known as tardive dyskinesia, which is an attractive orphan indication.

The Phase IIb KINECT study, which studied 120 patients, failed to beat placebo at the 50 mg dosing at 2 and 6 weeks, although statistically significant improvements were seen at the 100 mg dose at both 2 and 6 weeks This led analysts to defend the stock against the drop, although many investors were concerned about the effects the results could have on the later clinical development of NBI-98854. This will also force the company to perform another Phase II trial at the 100 mg dose to confirm what was seen in KINECT.Also, as stated by the company, the 100 mg dose was expected to be the maximum tolerated dose (MTD). Although the 100 mg patients appeared to tolerate the drug in this trial, previous data suggest that there may be some tolerability problems when a larger 100 mg trial is performed. This could lead to bigger problems with NBI-98854’s safety profile when the drug is eventually put up for final review.

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