AB Science reports positive Phase 2 results for masitinib in Covid-19 study

Paris, 8 July 2024, 8am CET – AB Science SA announced today the findings from a Phase 2 study examining the use of masitinib in treating COVID-19. The study, labeled AB20001, was a randomized (1:1), open-label trial aimed at assessing the safety and efficacy of masitinib along with isoquercetin in hospitalized patients suffering from either moderate (level 4) or severe (level 5) COVID-19 according to the WHO 7-point ordinal scale. Initially, the goal was to recruit 200 patients aged 18 and above, with no upper age limit.

The primary objective of the trial was to enhance the clinical status of patients after 15 days of treatment, as gauged by the WHO 7-point ordinal scale. However, based on recommendations from a Data and Safety Monitoring Board (DSMB), the study decided to focus solely on level 4 patients—those hospitalized with an oxygen requirement of less than 6 L/min while maintaining a SpO2 level of 92% or higher.

Unfortunately, the study could not meet its recruitment target of 200 patients, ultimately ceasing further enrolment after 95 patients had been randomized. The objective then shifted to identifying a promising treatment effect with these 95 patients, which could potentially translate into a significant effect if the originally planned 200 patients had been enrolled. If this revised goal was met, it would indicate the merit of continuing to explore masitinib as a therapeutic agent for COVID-19 in patients with moderate oxygen needs.

After 15 days of treatment, the study revealed an odds ratio of 2.4 in favor of the treatment group, surpassing the initially hypothesized odds ratio of 2.2. The p-value was simulated to be 0.038 with 200 patients and observed to be 0.072 with the 95 patients enrolled. Further sensitivity analyses on days 12, 13, and 14 for the 95 patients yielded p-values of 0.016, 0.019, and 0.018, respectively, with corresponding odds ratios of 3.2, 3.2, and 3.4. This improvement was attributed to certain placebo patients showing progress by day 15 but not earlier. Safety profiles aligned with the known safety data for masitinib.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and a member of the Académie des Sciences in France, commented on the results. He noted that the findings affirm masitinib’s anti-inflammatory capabilities by regulating activated macrophages and mast cells, which are implicated in COVID-19. Additionally, various studies have highlighted masitinib's potential as an indirect broad antiviral agent against COVID-19. Given these results, masitinib could be considered a promising drug candidate for evaluation in the context of future pandemics.

Alain Moussy, co-founder and CEO of AB Science, expressed gratitude towards the European Investment Bank for funding the development and to their partner Quercegen for suggesting the combination of masitinib with isoquercetin. Moussy emphasized that the promising results justify further evaluation, and AB Science plans to discuss the potential for continued research with public institutions and private partners.

AB Science, established in 2001, is a pharmaceutical company that focuses on the research, development, and commercialization of protein kinase inhibitors (PKIs). These targeted proteins play a crucial role in cellular signaling pathways. The company’s research primarily targets diseases with significant unmet medical needs, including those that are often fatal, rare, or resistant to previous treatments. AB Science has developed a proprietary portfolio of molecules, including its lead compound, masitinib, which has been registered for veterinary medicine and is under development for human use in oncology, neurological, inflammatory, and viral diseases. The company is headquartered in Paris, France, and is listed on Euronext Paris under the ticker "AB".