Date: 2015-02-02
Type of information: IPO
Company: Motif Bio (UK)
Investors:
Amount: £4 million (€ 5.33 million)
Funding type: IPO
Planned used: Motif Bio is a clinical stage biopharmaceutical company which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi). Discussions and negotiations with academic institutions and pharmaceutical companies are under way to build a portfolio of antibiotic candidates through licensing. The Directors anticipate that iclaprim could be ready for commercialisation within approximately 36 months. Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Originally discovered by F. Hoffman-La Roche Ltd, iclaprim is a DHFRi. Iclaprim was licensed to and developed by Arpida and in 2008, a request to the FDA and the EMA was submitted for approval to market the compound. On the basis of the submitted data, iclaprim was not approved and ceased to be developed. Motif Bio has completed due diligence, including a review of all of the preclinical and clinical data plus the US and European regulatory correspondence, and the Directors believe that iclaprim can be rapidly returned to late stage clinical testing with some improvements to the original development programme. The final clinical development plan will be confirmed in meetings with the FDA and the EMA, which are expected to take place within 6 months of Admission. The Group has a copy of the “Complete Response Letter” received by Arpida in January 2009 which confirms the reasons that iclaprim was not approved by the FDA based on the data submitted in 2008. This confidential information, together with the improved regulatory environment and the need for novel antibiotics that are effective against multi-drug resistant bacteria, support the Group’s plan for a rapid return to clinical development for iclaprim. Assuming that funds can be raised to complete clinical development and that the clinical trials are successful, the Directors believe that it is feasible to achieve approval to market within 36 months. MTF-001 is a programme to design a best-in-class DHFRi that will be effective against multi-drug resistant bacteria, with the aim of marketing a novel once daily antibiotic that can be administered by injection and taken orally in pill form. Based on iclaprim and other lead compounds, Motif Bio will establish a proprietary lead series with the objective of identifying a best-in-class DHFRi that is effective against a broad spectrum of Gram-positive bacteria, including those resistant to currently available antibiotics, that can be administered once daily in injectable (i/v) and orally in pill formulations. Several other programmes are also under discussion, including compounds designed to be effectiv
The company will use the proceeds of the placing to advance its drug development programme, in particular iclaprim and MTF-001. The financing will also be used to confirm in meetings with the FDA and the EMA in the first half of 2015 that the clinical development plan for iclaprim meets regulatory guidelines and that two Phase III trials can be conducted as proposed. Assuming that Motif receives regulatory approval to start Phase III testing in the second half of 2015, the Directors believe that iclaprim offers a rapid path to commercialisation, which would be expected to occur in 2018. A follow-on pipeline of preclinical antibiotics is being built to follow iclaprim. The funds will also provide Motif Bio with additional working capital for at least 18 months.
Originally founded as a population genetics company, Motif has, since 2009, focused on drug discovery and development and in late 2013, it was decided that Motif should focus exclusively on antibiotics. In December 2014 Motif evolved from a preclinical stage company to a late stage clinical company by conditionally acquiring Nuprim, a Maryland corporation owning the exclusive worldwide rights to a potential novel antibiotic called iclaprim. The completion of this acquisition is subject to Admission. Iclaprim completed clinical development and in 2008 an NDA and a MAA were submitted seeking approval to market in the US and EU, respectively. In 2009 the FDA declined to approve iclaprim based on the data submitted and subsequently the MAA was withdrawn in Europe. The scientific experts at Motif have reviewed the data package for iclaprim and have concluded that by addressing certain deficiencies in the original development programme, iclaprim can be returned to clinical development, re-submitted for review by the FDA and by the EMA and if approved, the Directors anticipate that iclaprim could be marketed within approximately 36 months.
Others: * On February 2, 2015, Motif Bio announced that the company is seeking to raise at least £4 million (€ 5.33 million) through a placing of new ordinary shares and admission to trading on AIM.
Therapeutic area: Infectious diseases
