Motif Bio
Motif Bio plc
One Tudor Street
London, EC4Y 0AH
United Kingdom
In June 2021, Motif Bio plc announced at its general meeting that several resolutions for the the proposed acquisition of BiVictriX Therapeutics were not passed, and as such the company would be cancelled from trading. Shares of Motif Bio PLC were suspended from trading in July 2021.
Motif Bio plc was a clinical-stage biopharmaceutical company focused on developing novel antibiotics. The company’s lead product candidate was iclaprim, an investigational broad-spectrum diaminopyrimidine antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The U.S. FDA issued a Complete Response Letter (CRL) in 2019 regarding the New Drug Application (NDA) for iclaprim stating that that additional data were needed to further evaluate the risk for liver toxicity. The failure to gain FDA approval for the drug resulted in the eventual demise of the company.
Latest news
- Motif Bio Announces Path Forward for Iclaprim following Receipt of FDA Meeting Minutes
6 June 2019 - Motif Bio Receives Complete Response Letter From The FDA
14 February 2019 - Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
14 August 2018 - Motif Bio Submits NDA for Iclaprim
14 June 2018 - Motif Bio REVIVE-2 Phase 3 Study Results with Iclaprim Published in Peer-reviewed Journal, Antimicrobial Agents and Chemotherapy
1 May 2018 - First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections
2 March 2016 - FDA Grants Fast Track Designation for Iclaprim
3 September 2015 - FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI
22 July 2015 - FDA Issues Complete Response Letter for Iclaprim
20 January 2009 - Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
21 November 2008
