InDex Pharmaceuticals Holding has received positive responses from FDA and EMA regarding its phase III development of the TLR9 agonist cobitolimod, for the treatment of moderate to severe ulcerative colitis.
Following the phase IIb study CONDUCT meeting its primary endpoint in August 2019, dialogues were initiated with FDA and EMA respectively, for the further development of cobitolimod. These processes have now been completed and both authorities endorse the advancement of cobitolimod into phase III studies in patients with moderate to severe left-sided ulcerative colitis.
Flexibility for different designs of the phase III program
This regulatory feedback gives flexibility for different designs of the phase III program, for example, to conduct studies sequentially and potentially to include a higher dose in addition to the highest dose regimen tested in the phase IIb study (2×250 mg), the company states. The company continues to evaluate the most advantageous study design based on, among other things, development risk, commercial potential, time to market and cost.
”The positive responses from the regulators is an important external validation of our study results and cobitolimod’s potential. These constructive dialogues demonstrate a common desire to see new treatment options that can help more patients with ulcerative colitis return to a normal life, which also would save considerable resources for society as a whole,” says Peter Zerhouni, CEO of InDex Pharmaceuticals.
Taking appropriate actions to use resources wisely
The Covid-19 pandemic affects the healthcare systems and the investor sentiment globally and must be taken into account in the company’s strategic planning. However, InDex is well capitalized and given the current level of activity and financial commitments, cash and cash equivalents, which at March 31 amounted to just over SEK 100 million, are sufficient to finance the business for at least 12 months, the company states.
“Before we can start phase III, the healthcare situation must have normalized, and the necessary funding be secured.”
”The turmoil in our world as a result of Covid-19 means that we need to consider additional parameters in our planning. So far, our phase III preparations are proceeding according to plan and we are taking appropriate actions to use our resources wisely under the present circumstances. Before we can start phase III, the healthcare situation must have normalized, and the necessary funding be secured. In addition to assessing the conditions for InDex conducting the phase III program, we continue to engage with potential partners, presenting the positive CONDUCT results and development activities,” says Zerhouni.