ImmuPharma (LON:IMM) has raised £8.3 million ($12.0 million) to propel its lupus drug through a Phase III study. The cash will support ImmuPharma through to the data readout from its 200-person transatlantic trial, at which point management will weigh up commercialization options.
|ImmuPharma CEO Dimitri Dimitriou|
London-based ImmuPharma pulled in the cash through an offering of stock. Nearly half of the money, £3.9 million, was generated through the placement of ordinary shares, with the other chunk coming from a deal with Lanstead Capital. ImmuPharma plans to siphon the majority of the funding into a randomized, placebo-controlled Phase III trial of Lupuzor, a drug it thinks may prevent the progression of lupus. The hypothesis is to be tested at 45 sites in the United States and Europe, at which 270 patients are to be screened with a view to completing enrollment this summer.
If ImmuPharma, which has partnered with CRO Simbec-Orion for the study, can hit that timeline, it will be on track to deliver data in the fall of 2017. Then, if the data are up to scratch, ImmuPharma intends to seek approval from FDA before assessing how to handle commercialization. As it stands, ImmuPharma is open to either securing royalties through a global licensing deal, raising additional money to commercialize Lupuzor itself in partnership with local distributors or selling the asset or company outright.
ImmuPharma has attracted interest in the program before, only to see the deal fall apart. Cephalon handed over $15 million--and committed up to $500 million more--in 2008 to get an option to pick up the drug if it delivered positive Phase IIb data. The clinical trial fell short of statistical significance, but ImmuPharma argued the performance of patients in with moderate to severe forms of lupus was strong enough to justify hailing the trial as a success. Cephalon appeared to agree and took up its option, only for the drug to get handed back to ImmuPharma when Teva ($TEVA) bought the firm.
Shortly after the deal fell apart late in 2011, ImmuPharma picked up fast-track designation from FDA and clearance to push ahead into Phase III. At that stage, ImmuPharma claimed to be in talks with potential partners, but a deal never materialized. In lieu of the financial backing and clinical research nouse of a biopharma partner, ImmuPharma has raised money through a patchwork of fundraising initiatives and tapped Simbec-Orion for clinical trial support. The £8.3 million follows the securing of a £50 million financing facility, raising of £3.4 million and $14 million deal with a U.S. investor.
With the near-term financial future of Lupuzor now secured, ImmuPharma is focusing some of its cash and attention on its earlier stage pipeline. ImmuPharma is planning to put money into a pair of peptide platforms, one of which has already spawned clinical-phase cancer drug IPP-204106, but is yet to reveal exactly what it intends to do. "During 2016, we will provide further guidance on both on how we will progress and in which conditions," Lisa Baderoon, head of investor relations at ImmuPharma, told FierceBiotech.