- Merck & Co.'s experimental antibiotic, the beta-lactamase inhibitor relebactam met its primary and secondary endpoints in combination with imipenem/cilastatin in a pivotal Phase 3 study, results of which were released Sunday.
- The combination "demonstrated a favorable overall response" in the treatment of bacterial infections that aren't susceptible to imipenem. The RESTORE-IMI study also found lower levels of kidney toxicity than Colistin plus imipenem.
- A second ongoing pivotal study is comparing a fixed dose of imipenem, cilastatin and relebactam with piperacillin plus tazobactam. Merck plans to submit a New Drug Application for a fixed dose combination of imipenem/cilastatin and relebactam to the Food and Drug Administration, but didn't disclose timing.
Big pharma has treaded lightly in the antibiotic space in recent years.
Companies are being asked to invest in antibiotics while competing against low-cost generics, at a time when healthcare professionals are being encouraged to cut the use of the drugs wherever possible.
With antibiotic resistance edging toward crisis levels, the most effective and innovative drugs could rarely see the light of day, being kept at the back of the cupboard as treatments of last resort.
Pharma has been criticized for exiting the field amid rising need for new treatments. In August 2016, for example, AstraZeneca plc sold its anti-infective portfolio to Pfizer Inc. for up to $1.6 billion.
Still, several companies seem to be bucking the trend. Sanofi and Roche AG both made deals with Warp Drive Bio Inc. to develop a number of novel classes of antibiotics targeting drug-resistant pathogens. GlaxoSmithKline also retains a foothold in antibiotics research.
And Sunday's announcement from Merck shows the pharma remains invested in this space. Relebactam has Qualified Infectious Disease Product (QIDP) status from the FDA, along with designated fast track status for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections.
In the study, the primary endpoint was favorable overall response, defined by endpoints for different infection types in the microbiological modified intent-to-treat population. Secondary endpoints included favorable clinical response at Day 28, 28-day all-cause mortality, treatment-emergent kidney toxicity, and adverse event incidence.