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- The European Medical Agency (EMA) has advised a single study on the drug will likely be sufficient for its requirements
- The advice is in for Invex Therapeutics (IVX) and its Idiopathic Intracranial Hypertension (IIH) treatment, Presendin
- While the U.S. Food and Drug Administration (FDA) has advised two studies will need to be carried out on the treatment
- Invex said following the advice it was committed to its phase three clinical trial but will tweak its wider development strategy for the U.S.
- Shares in Invex are trading down 13.7 per cent following the update, selling for 99 cents per share
Biopharmaceutical company Invex Therapeutics (IVX) has received preliminary scientific advice on the development of its Idiopathic Intracranial Hypertension (IIH) treatment, Presendin.
Presendin helps treat IIH, a rare condition where brain fluid is at a higher pressure than normal.
The company plans to apply for special status, under the Orphan Drug Designation Act, which means the drug will only be given out upon request.
Invex recently consulted with both the European Medical Agency (EMA) and the U.S. Food and Drug Administration (FDA) to see what they would need to do to get the drug to market, as well as to identify any potential roadblocks.
Preliminary advice shows while the EMA is happy with one study showing the drug is safe, the FDA requires more information and have asked for two studies to potentially be undertaken.
In particular, the EMA wants the drug tested alongside a placebo and measured by lumbar punctures examining intracranial pressure. While the FDA wants to see “clinically meaningful change” in visual function proven by two studies.
Following the feedback, Invex Chairman, Jason Loveridge, said they will continue to consult advisors and tweak their U.S. development plan.
“In consultation with our regulatory advisors and global clinical advisory board we devised a harmonised regulatory strategy providing an accelerated route for multiple market entry of Presendin™ in IIH,” he said,
The company will also push ahead with its phase three clinical trial, which is planned to take place in the first half of next year.
“We now have clear feedback from CHMP [an EMA body] on a registration pathway for Europe, which leaves us with a clear route to market in the EU under our orphan drug designation and access to the majority of our market opportunity given the European Union represents around 60% or A$1 billion of our combined annual addressable US-EU market in IIH2,” said the Chairman.
Following today’s update, shares in Invex were trading down 13.4 per cent at 98.8 cents each at 3.58 pm AEST.
