BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX): Announced Positive Phase-II Trial Results For BCX4161


Dallas, Texas 05/28/2014 (FINANCIALSTRENDS) – BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) yesterday announced positive results from its OPuS-1 study for the prophylactic treatment of hereditary angioedema which is a Phase IIa trial for BioCryst’s pipeline product BCX4161, administered orally. The proof of concept study met the primary efficacy endpoint and many secondary endpoints. The trial evaluated orally administered BCX4161 at a dose of 400 mg, three times a day for 28 days in hereditary angioedema patients with a high attack frequency. OPuS-1 was a two period cross over, placebo controlled, randomized clinical trial.

The primary goal for the trial was to assess the BCX4161’s clinical efficacy in reducing the frequency of attacks in hereditary angioedema patients while evaluating the safety and tolerability profile of the candidate.

Encouraging Study Results

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)’s OPuS-1 study evaluated the drug efficacy on 24 patients whereby the treatment with BCX4161 suggested a statistically significant mean attach rate reduction as compared to placebo. The company also reported that the oral dose of drug was safe and well tolerated. The company reported 98% patient dosing compliance. An adverse event profile was also similar to that of placebo. In addition, three patients were “attack-free” during the drug treatment as compared to none during the placebo period.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) also measured disease activity and quality of life using AAS28 (Angioedema Activity Score) and AeQoL (Angioedema Quality of Life questionnaire). AAS28 score was reported at 21.4 v/s 28.8, p=0.022 and AeQoL score improvement of 8.4 v/s 0.5 units from baseline, p=0.004, respectively for BCX4161 v/s placebo.

The Principal Investigator of OPuS-1 study, Marcus Maurer regarded the OPuS-1 as a “milestone” study as the proof of concept suggests prophylaxis to reduce attacks in patients living with hereditary angioedema.

Stock Update

Yesterday, the stock closed at $9.99, gaining nearly 11% from its previous close. The stock traded with significant volume of 7.84 million shares against its 30 day average volume of 680.37 K shares.

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