Tebipenem

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024
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“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Spero Therapeutics Announces First Patient, First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, January 2, 2024
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Spero is entitled to receive $95 million in development milestone payments from GSK, which is payable in four equal installments over two years.

Key Points: 
  • Spero is entitled to receive $95 million in development milestone payments from GSK, which is payable in four equal installments over two years.
  • “First patient visit, in the PIVOT-PO Phase 3 clinical trial, is an important milestone in our tebipenem HBr program,” said Sath Shukla, President and CEO of Spero Therapeutics.
  • "We are developing Tebipenem HBr to potentially be the first oral broad-spectrum carbapenem in the U.S. for use in patients with cUTI.
  • The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.

SPERO ALERT: Bragar Eagel & Squire, P.C. is Investigating Spero Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, November 3, 2023
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Our investigation concerns whether the board of directors of Spero have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Spero have breached their fiduciary duties to the company.
  • Spero, a clinical-stage biopharmaceutical company, focuses on identifying, developing, and commercializing treatments for multi-drug resistant bacterial infections and rare diseases in the United States.
  • The Company's product candidates include Tebipenem Pivoxil Hydrobromide (HBr), an oral carbapenem-class antibiotic to treat complicated urinary tract infections, including pyelonephritis for adults.
  • On March 31, 2022, Spero issued a press release announcing the Company’s fourth quarter and full year 2021 financial results.

Spero Therapeutics to Present at the 5th Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Tuesday, November 22, 2022
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A replay of the fireside chat will be available on the website following the conclusion of the event.

Key Points: 
  • A replay of the fireside chat will be available on the website following the conclusion of the event.
  • Spero Therapeutics, headquartered in Cambridge, Massachusetts,is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
  • However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr

Retrieved on: 
Tuesday, November 8, 2022
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3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Key Points: 
  • 3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.
  • In exchange, GSK has been granted an exclusive license to develop and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in all territories, except Japan, and certain other Asian countries, territories which will be retained by Spero partner, Meiji Seika.
  • Under the terms of the license agreement, Spero is responsible for the execution and costs of a follow-up Phase 3 clinical trial of tebipenem HBr.
  • GSK is responsible for the execution and costs of additional development, including Phase 3 regulatory filing and commercialization activities for tebipenem HBr outside of the Meiji Seika territory.

Spero Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on Monday, November 14, 2022

Retrieved on: 
Monday, November 7, 2022
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ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.

Key Points: 
  • ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.
  • To access the call, please dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international) and refer to conference ID 10020538.
  • The audio webcast can be accessed under "Events and Presentations" in the Investor and Media section of the Company's website at www.sperotherapeutics.com .
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

Spero Therapeutics to Host Virtual R&D Event on Non-Tuberculous Mycobacterial Pulmonary Disease and the SPR720 Program

Retrieved on: 
Monday, October 3, 2022
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CAMBRIDGE, Mass., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will host a virtual R&D event on Thursday, October 6, 2022, at 11:30 a.m. Eastern Time.

Key Points: 
  • The virtual event will feature a presentation by key opinion leader, Kevin L. Winthrop, MD, MPH, from the Division of Infectious Disease, OHSU Medical School.
  • During his presentation, Dr. Winthrop will discuss the etiology, unmet medical need, and treatment landscape of non-tuberculous mycobacteria (NTM) pulmonary disease.
  • Members of the Spero management team will provide an overview of the development program for SPR720, a potential novel first line oral therapy for NTM infections.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

GSK and Spero Therapeutics Announce Exclusive License Agreement for Late-Stage Antibiotic Asset, Tebipenem HBr

Retrieved on: 
Thursday, September 22, 2022
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LONDON and CAMBRIDGE, Mass., Sept. 22, 2022 (GLOBE NEWSWIRE) -- GSK (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive license agreement for Spero’s late-stage antibiotic asset, tebipenem HBr. Tebipenem HBr is being developed as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Key Points: 
  • In connection with the license agreement and pursuant to a stock purchase agreement between GSK and Spero, GSK has agreed to make a $9 million common stock investment in Spero, purchasing 7,450,000 shares of Speros common stock at a purchase price of approximately $1.20805 per share, not to exceed 19.99% beneficial ownership of Spero by GSK and its affiliates.
  • The closing of the equity investment is conditioned upon the effectiveness of the license following Hart-Scott-Rodino clearance.
  • As of June 30, 2022, Spero had cash, cash equivalents, and marketable securities of $45.4 million.
  • If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States.

Spero Therapeutics Announces Appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer

Retrieved on: 
Thursday, September 15, 2022
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CAMBRIDGE, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO) today announced the appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer (CMO).

Key Points: 
  • CAMBRIDGE, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO) today announced the appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer (CMO).
  • Kamal joins Spero with an impressive track record of building and leading successful anti-infective franchises, said Ankit Mahadevia, MD, Chief Executive Officer of Spero Therapeutics.
  • I am thrilled to have Kamal on our management team and look forward to working together.
  • Dr. Hamed has over 20 years of experience leading various anti-infective clinical development programs in antibacterials, antivirals, antimalarials, and antifungals.

Spero Therapeutics to Present at Upcoming Investor Conference

Retrieved on: 
Wednesday, September 7, 2022
Spero, Degenerative disease, Therapy, HBR, Infection, Tebipenem, Cutis verticis gyrata, GLOBE, Conference, Nasdaq, FDA, Pyelonephritis, Adult, MDR, Patient, Pharmaceutical industry

Webcasts of the presentations may also be accessed through Spero Therapeutics website ( www.sperotherapeutics.com ) on the Events and Presentations page under the Investors and Media tab.

Key Points: 
  • Webcasts of the presentations may also be accessed through Spero Therapeutics website ( www.sperotherapeutics.com ) on the Events and Presentations page under the Investors and Media tab.
  • Spero Therapeuticsis a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
  • Spero Therapeutics also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is in development to treat multi-drug resistant Gram-negative infections in the hospital setting.