The Anti-Infective Innovator Blog

Perspectives on Anti-Infective Drug Development

from Experts in the Trenches 

“Our mission at Spero is to bring novel, life improving therapies to patients suffering from infections, and there are key concepts that are unique to our field and the patients we serve. With the help of our team and key opinion leaders, we aim to amplify these topics for discussion with our collaborators within our field and in the biotech community.”    

     Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics

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Recent Publications

COVID-19 Has Made Hospital Avoidance a Critical Component of Good Care

August 11, 2020
By: Nayiri Baljian and Jennifer Reese

Since Spero began developing oral tebipenem for the treatment of cUTI, we have been consistent in advocating the importance of keeping patients who do not require hospitalization out of the hospital. Hospital avoidance has been a growing trend within the healthcare industry for many years, and today COVID-19 has made it an even more critical component of good medical care. Although most UTI patients can be treated at home, those with recurrent or resistant infections or who have failed oral antibiotics (“RRF” patients) often land in the hospital in order to receive IV therapy. We designed a Phase 3 trial comparing oral tebipenem HBr head-to-head with IV ertapenem to demonstrate that an oral carbapenem has the potential to be a more attractive treatment option than an IV carbapenem.

SPR720: Listening to patients, clinicians and regulators, and advancing forward

June 11, 2020
By: Troy Lister, PhD, Sue Stokes, PhD, and David Melnick, MD

Recently, Spero announced a positive meeting with the FDA that we believe supports our plans to advance SPR720, our novel oral agent for treatment of NTM disease, towards a Phase 2a clinical trial in NTM patients, which we intend to initiate in the second half of this year.

Evidence Matters: Importance of Tebipenem HBr Oral-Only Trial Design for Clinical Utility and Commercial Uptake Potential

February 26, 2020
By: Cristina Larkin and David Melnick, MD

Spero is developing tebipenem HBr to provide patients with complicated urinary tract infections (cUTI), the physicians that treat them, and the payors that support their care treatment options outside of the hospital, thus potentially reducing millions of days of hospitalization and billions of dollars in unnecessary health care costs.

Beyond the headlines: Why we are excited about our pipeline and the future for patients needing effective treatments for infections

January 9, 2020
By: Ankit Mahadevia, MD

Against a steady drumbeat of alarmist rhetoric in the lay press regarding infectious disease, at Spero we remain focused on developing our first-in-class pipeline of oral agents to treat what we believe to be the two largest infectious disease market opportunities: complicated urinary tract infections (cUTI) and nontuberculous mycobacterial (NTM) pulmonary disease.

New Options for Patients: New Clinical Data on SPR720 and our Stepwise Plan to Explore its Broad Potential in NTM

December 5, 2019
By: David Melnick, MD

We recently announced positive preliminary, blinded data on SPR720 that we believe supports the further development of SPR720 as an oral agent for the treatment of NTM pulmonary disease. The data released: 1) Identify a dose range for SPR720 to explore in human trials that is supported by animal and hollow fiber models across a range of NTM pathogens; 2) Suggest that SPR720 is safe and well-tolerated in a SAD/MAD clinical trial of healthy volunteers at the predicted therapeutic dose range; 3) Support progression of SPR720 into our planned Phase 2 dose-ranging clinical trial in non-refractory NTM-lung disease patients, pending acceptance of an investigational new drug application by the FDA. We believe that the proposed Phase 2 clinical trial will establish an efficient paradigm for the progression of new anti-NTM agents.

Exciting Independent Review Committee Recommendation Announced Today Based on Positive Interim PK Data from SPR994 ADAPT-PO Phase 3 Clinical Trial

October 3, 2019
By: David Melnick, MD

Today we announced that an independent review committee evaluated pharmacokinetic data following enrollment of the first 70 patients in Spero’s ongoing ADAPT-PO pivotal Phase 3 clinical trial of SPR994, Spero’s oral carbapenem product candidate, and recommended that Spero continue the trial using the protocol-defined dose without modification. SPR994 is our oral carbapenem being developed to help patients with serious urinary tract infections go home and stay home from the hospital.

New Strategic Alliances to Build Industry Leading Pipeline: Partnerships with Gates MRI and the Novo REPAIR Impact Fund Validate and Accelerate Development of SPR720

July 2, 2019
By: Troy Lister

Since its founding, Spero has built strategic partnerships to advance its multi-asset, clinical-stage pipeline, raising approximately $44 million in committed non-dilutive funding since inception, with the potential to receive up to a total of $122 million in such funding, including potential milestone opportunities and full awards.

SPR994's Value Proposition: A dive into how SPR994, an oral carbapenem, could benefit patients, payers, and investors

May 16, 2019
By: Joel Sendek

Spero has an enterprise value that does not reflect what we believe are significant market opportunities for our lead asset, an oral carbapenem SPR994, and our other product candidates.

Why Are We Losing Oral Antibiotics for the Treatment of cUTI?

March 6, 2019
By: Ian Critchley, Ph.D.

Urinary tract infections (UTI) caused by pathogens such as Escherichia coli, the most prevalent UTI pathogen, have been historically managed with oral agents including the cephalosporins, trimethoprim-sulfamethoxazole (TMP-SMX) and the fluoroquinolones. Not surprisingly, widespread use has resulted in increased resistance over time.

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?

January 7, 2019
By: David Melnick, MD and Cristina Larkin

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 the treatment of complicated urinary tract infection (cUTI)....

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

November 5, 2018
By: Ankit Mahadevia, MD and Cristina Larkin

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.

Investing in Antibiotic Companies:
Asking the Right Questions about Dose Selection Increases Probability of Clinical Success

October 1, 2018
By: Joel Sendek

As an analyst earlier in my career, one of the first stocks I ever placed a Buy rating on had the following characteristics: All the other analysts gave it a Hold rating, and it was one of the only players attempting to launch a novel product in a genericized market that most big pharmaceutical companies already abandoned. Does that sound familiar?

Spero’s New Inter-agency Collaboration:
Furthering SPR994 Development with Non-Dilutive Funding

July 16, 2018
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.

Advancing Spero's Potentiator Platform

May 30, 2018
By: Ankit Mahadevia and Troy Lister

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. There are many contributors to these troubling statistics, with one being a lack of novelty in the way such infections are treated.

Billion Dollar Antibiotics in the Era of Stewardship:
It is Possible by Following 3 Guiding Principles

April 25, 2018
By: Cristina Larkin, David Melnick, and Keith A. Rodvold

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 expectations. What has led to the seeming bifurcation of commercial success and stewardship, and how do we fix it?

Antibiotic Drug Development:
Asking the Right Questions about Dose Selection Increases Probability of Clinical Success

March 26, 2018
By: Ankit Mahadevia, David Melnick, and Paul Ambrose

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?

-- More Publications Coming Soon --