The ImmuPharma PLC (LON: IMM) share price spiked 23.6% higher after issuing an update about its Lupuzor™ programme that treats systemic lupus erythematosus (SLE), the company revealed that it had decided to conduct a phase 2/3 adaptive clinical trial.
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ImmuPharma is working in collaboration with its partner Avion Pharmaceuticals. The two firms decided that the adaptive two-phase study would be the best option for the Lupuzor™ programme based on advice from the Food and Drug Administration (FDA).
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The adaptive phase 2/3 clinical trial will also utilise higher doses of Lupuzor™ than the two firms had used in previous studies with the FDA’s approval after the companies established a clean safety profile at the higher doses.
In addition, the two-phase design will eliminate the disruptions caused by having to end one study to begin another. The firms will transition smoothly from the phase 2 study to the phase 3 study without a significant break between the two.
Therefore, the combined study will take less time than if they did the two trials separately. Luckily for investors, ImmuPharma and Avalon are doing this with the FDA’s approval, eliminating the chances of regulatory holdups, double site-checks and ethics approval since all these steps will be done at the beginning of the trial.
The adaptive phase 2/3 trial could also end earlier than scheduled if the data indicates an efficacy signal has been reached after a percentage of the enrolled patients have been treated. Investors cheered the news, as evidenced by the rally in ImmuPharma shares.
Tim McCarthy, ImmuPharma’s CEO, said: “We have had extremely productive discussions with Avion over the last few weeks on the Lupuzor™ programme, and we have agreed that the optimum way forward for Lupuzor™ is to undertake an adaptive Phase 2/3 trial. Our key focus will be to commence the trial during H2 2023.”
*This is not investment advice.
ImmuPharma (IMM) share price.
The ImmuPharma share price spiked 23.57% higher to trade at 3.25p, from Friday’s closing price of 2.63p.
YOUR CAPITAL IS AT RISK. 76% OF RETAIL CFD ACCOUNTS LOSE MONEY.