Blog Coverage Cempra Announced Positive Results from the Phase-III Study for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Upcoming AWS Coverage on BioMarin Pharmaceutical Post-Earnings Results
LONDON, UK / ACCESSWIRE / February 27, 2017 / Active Wall St. blog coverage looks at the headline from Chapel Hill, North Carolina-based Cempra, Inc. (NASDAQ: CEMP) as the Company announced on February 24, 2017, positive Phase-3 trial results of oral fusidic acid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The Company noted that Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority (NI) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population. Register with us now for your free membership and blog access at:
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One of Cempra's competitors within the Biotechnology space, BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported on February 23, 2017, financial results for the fourth quarter and year ended December 31, 2016. AWS will be initiating a research report on BioMarin Pharma in the coming days.
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Study Design and Demographics
The phase-3 oral fusidic acid double-blind study was conducted at 62 sites in the United States in 716 patients. Patients randomized to treatment with oral fusidic acid received a loading dose of 1,500 mg every 12 hours for two doses, followed by 600 mg every 12 hours thereafter, until the end of a 10-day course of therapy. Patients randomized to treatment with the active comparator, oral linezolid, received 600 mg every 12 hours for 10 days. Randomization was 1:1 and was stratified by type of infection, by age and by prior use of an antibiotic within 36 hours prior to randomization.
Cempra stated that overall, 67.5% of study subjects had an infection associated with intravenous drug abuse. Less than five percent of study subjects received an antibiotic prior to randomization.
Study Results
The primary endpoint ECR was defined as the proportion of patients alive and achieving a ≥ 20% reduction from baseline in lesion size at 48-72 hours after the start of the study drug, without receiving rescue antibiotics. In the study, 87.2% of ITT patients receiving fusidic acid demonstrated ECR compared to 86.6% of ITT patients receiving linezolid.
Fusidic acid also showed comparable efficacy to linezolid in investigator-assessed clinical response in the ITT and clinically evaluable (CE) populations at EOT and PTE visits.
Cempra stated that in the study, microbiological response rates by pathogen were high in both treatment groups in both the microbiological ITT (mITT) and microbiologically-evaluable (ME) patient populations (patients with isolation of a baseline pathogen, who were also clinically evaluable). The most common pathogens identified were Staphylococcus aureus, Streptococcus anginosus group species, Streptococcus pyogenes, and Clostridium species. Notably, the microbiological success rate among fusidic acid recipients in each ME population with methicillin-resistant S. aureus (MRSA) infection was 100% at both the EOT and PTE visits.
Tolerance Points
Cempra noted that Fusidic acid was well tolerated in the study and that the rates of treatment-emergent adverse events (TEAEs) were comparable between treatment groups. The most common TEAEs in both treatment groups were gastrointestinal events. The Company stated that Serious adverse events (SAEs) occurred in six fusidic acid recipients and eight linezolid recipients, and were considered study-drug related in one fusidic acid recipient (vomiting) and in two linezolid recipients.
Way Ahead
Cempra announced that it will submit the full data from this study for presentation at an upcoming scientific forum.
"We are excited that the results of this phase-3 study with fusidic acid confirm the results of our phase-2 study and are consistent with the more than 40 years of experience that the product has accumulated outside the United States," said David Oldach, M.D., Chief Medical Officer of Cempra.
"We look forward to meeting with the FDA to discuss the next steps required to bring fusidic acid to patients in the United States," Oldach added.
About Fusidic Acid
Cempra is developing fusidic acid exclusively in the US for ABSSSI and is exploring its use for the long-term oral treatment of refractory bone and joint infections. Fusidic acid is orally active against gram-positive bacteria, including Staphylococcus aureus strains such as healthcare-acquired methicillin-resistant Staphylococcus aureus (HA-MRSA) and community-acquired MRSA.
Stock Performance
At the close of trading session on Friday, February 24, 2017, following the announcement, Cempra's stock price soared 28.57% to end the day at $4.05. A total volume of 21.59 million shares were exchanged during the session, which was above the 3-month average volume of 2.23 million shares. The Company's share price has gained 37.29% in the past one month and 44.64% on YTD basis. The stock currently has a market cap of $165.00 million.
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