Synthetic Biologics (NASDAQ:SYN)
On February 3, 2016 shares of Synthetic Biologics fell by 14% after the company announced an update on the phase 2 clinical trial treating patients with Relapsing-Remitting Multiple Sclerosis — RRMS. The company’s drug used to treat these patients with RRMS is known as Trimesta. Both the clinical and MRI results of the phase 2 trial demonstrated that Trimesta did not produce statistically significant results compared to placebo.
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One thing to note though is that the Trimesta drug was combined with Copaxone and Copaxone was put together with placebo. The trial showed that Trimesta with Copaxone failed to be superior than Copaxone/placebo at both the 12 month and 24 month period. With this terrible clinical results the company has chosen to abandon the Trimesta program completely. Obviously from the results posted it was the smart thing to do, as any further testing would have clearly not yielded any better results.
The company does have some promise though, because it has shown positive phase 2 results in two gut microbiome programs. This means that the company is poised to advance to late-stage clinical trials with these products despite the failure of the Trimesta product. In addition to pulling the plug on the Trimesta program, Synthetics had to terminate its license agreement with the University of California for Trimesta.
Conatus Pharmaceuticals (NASDAQ:CNAT)
On February 4, 2016 shares of Conatus Pharmaceuticals finished the day up 22% after the company announced that the FDA had granted their drug, known as Emricasan, FDA Fast Track Status for NASH Cirrhosis. There has been a slew of dialogue going back and forth between Conatus and the FDA on the possible development path for Emricasan. Both have agreed to begin a potential trial in NASH Cirrhosis, and then pending positive clinical results move to NASH Fibrosis.
In order to obtain this Fast Track Status from the FDA, the company had to submit data from a clinical trial that treated patients with portal hypertension. This clinical trial used Emricasan as the main drug, and it was able to improve patients disease with only one month of treatment. Although, don’t believe that Fast Track was given just because of positive efficacy observed. There are other criteria a drug must meet in order to obtain such a status.
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For a biotechnology company to receive an FDA Fast Track Status it must not only show efficacy, but it also have to fulfill unmet medical needs. What this means is that the drug treats a disease where patients have no other viable drug options. The FDA wants to Fast Track such drug products because they make therapies available where none exist. Shares of Conatus have been lagging along with the rest of the biotechnology sector, but the company remains on track as a long-term investment in NASH and other liver diseases.
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