This morning, the company said the delay in approval of solithromycin forced the termination as Cempra has been forced to undergo a reduction of costs. Cempra said its workforce will be reduced from 136 people to 45 employees. The cost reduction will also impact external spending related to commercial preparedness and non-essential activities, the company said in a statement.
Cempra says it has combed through data from an initial patient cohort of 262 patients in the so-called SOLITAIRE-U phase 3 study, which was geared to look how a single 1000-mg dose of oral solithromycin fared in uncomplicated genitourinary gonorrhea (GC), with or without concomitant chlamydia infection, compared with an injected antibiotic ceftriaxone alongside an oral antibiotic, azithromycin.
“I think it’s concerning. We have relied for so long on just newer and newer antibiotics. But obviously the bugs can often [develop resistance] faster than we can make new ones,” Dr. Alexander Kallen, a medical officer at the Centres for Disease Control and Prevention’s division of health care quality promotion told Stat News.
North Carolina-based Cempra on Thursday reported that it had received the CRL from the FDA that focused primarily on the need for a much larger clinical study to determine the safety of its experimental oral and intravenous antibiotic solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The FDA also told the Chapel Hill company that manufacturing deficiencies noted at its API makers will have to be resolved before the drug can be considered again for approval.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) relating to the company’s new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults
Cempra Appoints Dr. David as Acting CEO, Promotes CCO Moore to President
Solithromycin’s benefits outweigh its risks but developer Cempra has not adequately characterized how likely the antibiotic is to cause liver damage according to a US FDA panel.
Nov 4 The effectiveness of Cempra Inc's experimental antibiotic to treat community acquired pneumonia outweighs the risk of liver injury, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.
Cempra Inc's experimental drug to treat community-acquired pneumonia, the kind recently suffered by presidential candidate Hillary Clinton, causes a potentially concerning rise in liver enzymes, according to a preliminary review by the U.S. Food and Drug Administration.