Motif Bio PLC, Spero Therapeutics and Vical Incorporated Join Antimicrobials Working Group

WASHINGTON, Jan. 29, 2018 /PRNewswire/ -- The Antimicrobials Working Group (AWG) announced today the addition of three new members to its coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations. Motif Bio (AIM/Nasdaq: MTFB), is a clinical-stage biopharmaceutical company focused on developing novel antibiotics to treat hospitalized patients with serious and life-threatening infections caused by multi-drug resistant (MDR) bacteria. Spero Therapeutics (Nasdaq: SPRO), is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for MDR bacterial infections. Additionally, AWG recently welcomed Vical, Inc. (Nasdaq: VICL), a biopharmaceutical company focused on the development of products for the prevention and treatment of chronic or life-threatening infectious diseases based on patented DNA delivery technologies and other therapeutic approaches.

These new additions bring AWG’s membership to 17 antimicrobial drug and diagnostic device development companies.

“Since AWG was founded in 2012, the coalition has grown substantially in size and scope, and has become increasingly influential in driving legislation and public policy that promote innovation in the treatment of infectious diseases,” said Jeffrey Stein, Ph.D., Chairman of AWG. “Through the strength of our collective membership, AWG looks forward to continued engagement with key stakeholders to remove hurdles that prevent health care professionals from having a full armamentarium of treatment options to combat drug-resistant threats.”

“The AWG is playing a critical role in raising awareness and increasing understanding of the urgent need for new and innovative antimicrobials. We are delighted to be joining the group at a time of critical importance for Motif as we prepare to submit our first New Drug Application (NDA),” said Graham Lumsden, Chief Executive Officer of Motif Bio.

“Spero Therapeutics is proud to become a member of the AWG and we are committed to amplifying the efforts of the committee in its mission to improve the regulatory, political and investment climate for antimicrobial companies,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics.

“New anti-microbial drugs are urgently needed to treat patients with difficult to treat or drug-resistant infections,” said Vijay Samant, Vical’s President and CEO. “Vical is pleased to be joining in the important policy initiatives of AWG to support in the development and approval of these therapies.”

All pharmaceutical and biotechnology companies developing new antimicrobial therapeutics and diagnostic devices are eligible for consideration of membership in AWG. If you are interested in learning more about becoming a member of AWG, please contact us here.

About Motif Bio

Motif Bio plc is a clinical-stage biopharmaceutical company engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria, including MRSA. The Company’s lead product candidate, iclaprim, is being developed for high-risk MRSA patient populations. Motif is preparing to submit a New Drug Application for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalized annually in the United States. The Company believes that iclaprim may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment. The Company is also developing iclaprim for the treatment of hospital-acquired bacterial pneumonia as well as Staphylococcus aureus lung infections in patients with cystic fibrosis, for which Motif has received orphan drug designation in the United States.

For more information, visit: www.motifbio.com.

About Spero Therapeutics

Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.

Spero is advancing SPR994, which is designed to be the first broad-spectrum oral carbapenem antibiotic for use in adults to treat MDR Gram-negative infections.

Spero is also advancing its potentiator platform of direct and indirectly acting polymyxin analogs. The product candidates are two IV-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting.

Spero is also developing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.

For more information, visit: https://sperotherapeutics.com.

About Vical

Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on patented DNA delivery technologies and other therapeutic approaches.

Vical’s VL-2397 is a novel antifungal agent in clinical development for the treatment of invasive aspergillosis. The U.S. Food and Drug Administration (FDA) has advised that VL?2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency’s advice. The LUI is a provision of the Limited Population Pathway established under the 21st Century Cures Act of 2016. Vical is in the process of initiating a Phase 2 trial for the treatment of IA in acute leukemia patients and allogeneic hematopoietic cell transplant recipients.

Vical also has DNA vaccine programs in development, including VCL-HB01, an HSV-2 vaccine which is currently being evaluated in a Phase 2 trial.

For more information, visit: www.vical.com

About The Antimicrobials Working Group

AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of seventeen antimicrobials and diagnostics companies: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Arsanis Inc., Cidara Therapeutics Inc., ContraFect Corporation, Iterum Therapeutics Ltd., Melinta Therapeutics Inc., Motif Bio PLC, Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., SCYNEXIS Inc., Spero Therapeutics, Inc., T2 Biosystems Inc., Theravance Biopharma U.S. Inc., VPS-3 Inc., Vical Incorporated, and Zavante Therapeutics Inc.

For more information, visit: www.antimicrobialsworkinggroup.org

About The Conafay Group

The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

For more information, visit: www.conafaygroup.com

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SOURCE Antimicrobials Working Group (AWG)