On September 26, 2018 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its interim results for the six months ended 30 June 2018 (the "Period") (Press release, ImmuPharma, SEP 26, 2018, View Source [SID1234529587]).
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Key Highlights
Lupuzor
Lupuzor demonstrated a superior response rate over placebo (52.5% vs 44.6% "responders") in the primary analysis on the Full Analysis Set of all 202 patients. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met.
Across the whole study population, in those patients who had anti-dsDNA autoantibodies, LupuzorTM demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) LupuzorTM plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218).
The study confirmed the outstanding safety profile of LupuzorTM, with no serious adverse events reported.
As announced on 7 September 2018, agreement signed with a specialist provider to enter LupuzorTM into a ‘Managed Access Programme’
Open label extension study completes recruitment
Other programs
Nucant (cancer) program – Clinical Development Collaboration with Incanthera Limited Peptide platform program / Ureka subsidiary – ImmuPharma to begin divestment process Financial Position £10 million fundraising (before expenses) successfully completed in January 2018 Stable financial performance over the Period, in line with market expectations
– Net assets of £9.9 million (31 December 2017: £3.6 million).
– Loss for the period of £4.1 million (H1 2017: £3.0 million)
Research and Development expenses of £2.5 million (H1 2017: £2.3 million)
– Basic and diluted loss per share of 2.94p (H1 2017: 2.34p)
Appointment of new joint brokers
Stanford Capital Partners and SI Capital appointed as joint brokers, working in conjunction with current NOMAD and broker, Northland Capital Partners
Commenting on the Interims and outlook Tim McCarthy, Chairman, said:
"The Board is pleased to announce the interim results for the six months ended 30 June 2018. It has been a busy period for the Board following the announcement of the Phase III trial results for Lupuzor in April 2018. We remain focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and knowhow. We were obviously disappointed with the outcome of the Phase III trial results but are excited to be progressing the Managed Access Programme with a new strategic partner, which allows lupus patients early access to LupuzorTM. In the medium term, we remain focussed on achieving the full regulatory approval of LupuzorTM which we believe has the potential to be a ground breaking drug for lupus patients with blockbuster potential in commercial terms.
Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years. We are equally excited by the potential of both. We believe the strategy we announced earlier this month, together with a robust financial position, will create enhanced value for shareholders going forward."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")