Designing the Right Clinical Trial to Yield the Greatest Value

A Registration Trial May Provide Data For Approval, But Is It Sufficient To Answer Treatment Decisions From Healthcare Providers And Payors?

Designing the Right Clinical Trial to Yield the Greatest Value

By: David Melnick, MD  and Cristina Larkin  January 7th, 2019 In today’s health care environment, a randomized, well-controlled trial must not only meet the requirements for approval, but just as importantly, it must encourage early physician use and provide payors a justification for payment. Today, we announced positive feedback from our pre-Phase 3 FDA meeting for SPR994 for […]

Non-tuberculous Mycobacterial Disease: The Unmet Need and a Possible New Solution with SPR720

By: Ankit Mahadevia, MD  and Cristina Larkin   November 5th, 2018 Non-tuberculous mycobacterial (NTM) disease is a rare, chronic infectious disease with limited treatment options that has a devastating impact on patients and their families.  We at Spero are excited to announce that SPR720, our oral, broad-spectrum compound for NTM, will be entering clinical development in early 2019. SPR720 […]

Spero’s New Inter-agency Collaboration

By: Ankit Mahadevia Today we are pleased to announce our collaboration with BARDA, DTRA and USAMRIID for the further development of our oral carbapenem product candidate SPR994. What it means for patients A significant unmet need exists for an oral broad-spectrum antimicrobial to keep patients with complicated Gram-negative infections out of the hospital or allow them […]

Advancing Spero’s Potentiator Platform

By: Ankit Mahadevia and Troy Lister May 30th, 2018 The Platform and What It Means for Patients The CDC estimates that every year, at least 2 million people are infected with drug resistant bacteria and that the number of deaths resulting from these infections is equivalent to one fully loaded jumbo jet crashing each week.  […]

Billion Dollar Antibiotics in the Era of Stewardship:

By: Cristina Larkin, David Melnick, M.D., and Keith A. Rodvold, Pharm.D., FCCP, FIDSA April 25th, 2018 Can billion-dollar antibiotics and stewardship co-exist?  In an era where we are seeing increasing resistance to antibiotics it seems intuitive that there would be large market opportunity for new, effective antibiotics.  However, peak year sales of recent launches haven’t lived up to […]

Antibiotic Drug Development:

By: Ankit Mahadevia, David Melnick, and Paul Ambrose March 26th, 2018 A recent analysis of drug development success rates from Phase I to approval found that the average infectious disease drug is 10 times more likely to succeed compared to the average oncology drug (a complementary analysis here–  different magnitude, same directionality).  Why? In our opinion, highly accurate […]