Amid soaring interest in antibiotics that could defeat drug-resistant bacteria, Nabriva Therapeutics AG has amassed $120 million in funding commitments to drive a novel bacterial-pneumonia therapy toward regulatory approval.
Large drug makers in the mid-1990s started moving away from antibiotics, which are used for short periods, in favor of developing chronic-disease treatments that are taken for many years. Regulatory uncertainty also discouraged antibiotic investment, some observers say.
Attitudes have shifted recently. Rising drug resistance threatens to render many antibiotics ineffective. Products like Cubicin, a Cubist Pharmaceuticals Inc. treatment for certain blood and skin infections, have emerged as large sellers. Sales of Cubicin, which topped $1 billion last year, led dustbin of our space,” Dr. Yu said.
Nabriva this year plans to begin testing its lead drug in Phase III clinical trials of patients with community-acquired bacterial pneumonia. The drug, lefamulin, belongs to a new class of antibiotics called pleuromutilins. Though scientists have known about pleuromutilins since the 1950s, no one has won regulatory approval for an oral or intravenous pleuromutilin drug, Nabriva Chief Executive Colin Broom said.
Nabriva scientists have removed toxicities that held pleuromutilins back from being used as oral or intravenous drugs. They have also engineered in more stability and properties that enable them to be taken orally and intravenously, Dr. Broom said.
Nabriva’s lefamulin attacks bacteria’s ribosome, their protein-making machinery. Nabriva’s product zeroes in on a central portion, called the peptidyl transferase center. Bacteria need a functioning peptidyl transferase center to survive. This makes it a good target for antibiotics, Dr. Broom said.
In January 2014 U.S. regulators issued a draft guidance detailing a new endpoint companies could use in community-acquired bacterial pneumonia trials. In its Phase III studies Nabriva will look for a clinical response between day three and day five of treatment. This is the period in which patients normally respond to antibiotic treatment, Dr. Broom said. Before the draft guidance it was less clear what clinical endpoints companies should use in this indication, he said.
Nabriva also will use a second endpoint so it can secure approval in Europe. It will determine if patients have fully recovered from their infection five to 10 days after the full course of antibiotic treatment.
Competitor Cempra Inc. said in January that it received positive top-line data from a Phase III study of a drug for community-acquired bacterial pneumonia. It was the first such study completed since the draft guidance issued last year.
Nabriva backers are betting there is room for more than one new entrant. About a million Americans are hospitalized with pneumonia each year and 50,000 die from the disease, according to the Centers for Disease Control and Prevention.
An initial $50 million tranche will enable Nabriva to launch its Phase III trials. The company can call down the remaining $70 million as needed to complete the studies and file for U.S. and European approval. The company, which spun out of Novartis AG’s Sandoz division in 2006, is based in Vienna and has a U.S. subsidiary in Philadelphia.
Dr. Broom, former chief scientific officer of ViroPharma Inc., said he was prepared for semiretirement after Shire PLC acquired ViroPharma last year. When Nabriva approached him in August, he decided to join the company because of the great need for new antibiotics, he said.
Vivo led this Series B round along with new investor OrbiMed Advisors. The round also included new backers EcorR1 Capital and Boxer Capital of Tavistock Life Sciences. Previous investor HBM invested above its pro rata. Return investors GLSV, Novartis Venture Fund, Phase4 Partners and Wellcome Trust also participated.
Vivo’s Dr. Yu and OrbiMed Private Equity Partner Chau Khuong are joining the Nabriva board.
Write to Brian Gormley at email@example.com