BioCryst Pharmaceuticals (NASDAQ: BCRX)
On February 8, 2016 shares of BioCryst Pharmaceuticals fell by more than 71% after the company had announced that it had failed a phase 2 trial. The phase 2 trial known as the OPuS-2 trial recruited a total of 108 patients with Hereditary Angiodema — HAE. HAE is a rare genetic disorder that occurs in approximately 1 in 10,000 to 1 in 50,000 people. This disease causes certain parts of the body to swell. This either happens when a stressful event occurs or it can occur randomly without cause.
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There does come a time where swelling in some parts of the body can become fatal for the patient in question. This can happen when the swelling occurs in the airway and obstructs oxygen from getting into the lungs. This can also occur when swelling in the intestinal tract causes a blockage of food, causing a painful situation. The trial was divided up into three different parts:
- One group of 36 patients took 500 mg of avoralstat
- One group of 36 patients took 300 mg of avoralstat
- Remaining 36 patients took placebo drug instead
The primary endpoint of the trial was to determine if the drug, avoralstat, could produce a reduction in the mean attack rate compared to placebo. That means a reduction in the amount of swelling a patient incurs on their body over a period of time. The 300 mg dosage of avoralstat reduced the attack rate to 0.71 and the 500 mg dosage of avoralstat reduced the attack rate to 0.63. While the avoralstat drug reduced the attack rate in these patients with HAE, it didn’t match up to the placebo compound in the trial. The placebo compound reduced the attack rate down to 0.61. This means that the placebo performed better than bot the 300 mg and 500 mg of avoralstat.
Is there any hope left for Biocryst Pharmaceuticals? That all depends upon future data that is close to materialize. Such data is where the company is testing other doses of avoralstat in these patients with HAE, and data from these other trials are expected to release by mid-year 2016. If the data released at that time proves to be successful then there is a chance that the company’s share price can recover.
Incyte Corporation (NASDAQ: INCY)
On February 11, 2016 Incyte Corporation announced that it would discontinue a phase 3 trial that was treating patients with pancreatic cancer. The reason for stopping this trial early was because the drug was not producing enough efficacy. The limited efficacy was discovered when the company performed an interim analysis. The analysis concluded that Jakafi, Incyte’s drug, did not produce enough efficacy to warrant the trial continuing in its current state.
Pancreatic Cancer is the toughest form of cancer to treat therefore this trial using Jakafi was always a long shot at best. This failure wouldn’t be so bad if it was the only one. The only problem is that another cancer trial that used Jakafi failed to produce efficacy as well. This was another trial that was stopped early after an interim analysis concluded that Jakafi failed to produce substantial efficacy in patients with colon cancer.
Even though these trials failed to produce enough efficacy to move forward Incyte will still present data from these trials at an upcoming medical conference. While Jakafi continues to fail in solid tumor cancer trials, there is one bright spot that it does shine in. Jakafi does well in hematological malignancies or cancer of the blood. Matter of fact, it has already been approved by the FDA to treat two types of blood cancer products. Jakafi is approved by the FDA to treat myelofibrosis — a blood cancer and polycythemia vera — a rare bone marrow disorder.
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Jakafi already does well in blood cancer. It has been able to produce $601 million in revenue in 2015 for Incyte. Even though the company was not successful in solid tumor cancers, as long as it continues to deliver well in the blood cancer space it should do well as a long-term investment.
[Image Courtesy of Wikipedia]