BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) has announced preliminary findings from a Phase II study with intramuscular injection of Peramivir, the Company’s product candidate for the treatment of seasonal and life-threatening influenza.
It states that 344 patients who had a positive rapid antigen test indicating acute influenza illness were randomized to receive intramuscular injections of either placebo or one of two dose levels of peramivir (150mg and 300mg) as a single dose administered within 48 hours of symptom onset. The primary endpoint of the study was the time to alleviation of symptoms in the patients with confirmed influenza infection (n=313).
Here is the problem……..While the results indicate that in the evaluable population of 313 subjects, a single dose of peramivir demonstrated a treatment improvement over placebo, the improvement was not statistically significant. With regard to the primary endpoint of median time to alleviation of symptoms, the improvement over placebo was 22.9 hours with the 150mg dose (p=0.284) and 21.1 hours with the 300mg dose (p=0.152). Based on a preliminary review, the Company believes that due to the introduction of a shorter injection needle in the Phase II trial compared to the Phase I trial, only one-third of subjects received an adequate intramuscular injection.
The company is moving ahead and it sounds like the company is blaming too many patients receiving shots with too short of a needle. You’ll have to decide on your own if they are telling the truth or not.
The company just completed a private placement back on August 9 of $65.3 million, so this is going to be a likely burn for many of the investors. This appears to not be its only oar in the water. Fodosine is in studies for T-Cell Leukemia, CTCL, Chronic Lymphocytic Leukemia, and B-ALL. It also is studying BCX-4208 for autoimmune disease and transplantation.
In after-hours trading activity, shares are down nearly 40% at $7.17. On August 9, back when it completed its private placement, shares closed that day at $9.59 and shares had run up to over $12.00 recently before closing at $11.78 today. Its 52-week trading range is $6.57 to $13.38.
Jon C. Ogg
September 19, 2007