Biotech: With Phase II trials underway, Dimerix eyes first-mover advantage in the US market
Health & Biotech
Health & Biotech
When it comes to the listed biotech space, getting the communication right is critical.
For starters, it’s a sector geared around medical breakthroughs usually based highly complex science.
And for investors and market analysts, the outcome of key clinical trials often has a significant bearing on the price action for a given stock.
As a case in point, shares in nerve regeneration company Orthocell (ASX: OCC) shot higher this morning after an interim clinical trial should significant improvement among patients using its CelGro technology.
Orthocell is one of four companies presenting at tomorrow’s Biotech Luncheon in Perth, which aims to provide a platform for investors to better understand the exciting things happening in the local biotech space.
Another company presenting at the luncheon is Dimerix (ASX:DXB), a biopharma stock that’s developing two new products used to treat diabetic kidney disease and focal segmental glomerulosclerosis (FSGS) — or scarring of the kidney.
The company is currently undertaking fully-recruited Phase II clinical trials for both medicines, and is strategically positioned with a focus on the US market.
Speaking with Stockhead, Dimerix CEO Nina Webster highlighted that effectively communicating the complex processes involved in biopharmacy isn’t always easy.
“Getting the message out there is important. Every biotech is going to tell you they’re undervalued, but the challenge for us we have two phase II trials running with a market cap of only $16m,” Webster said.
“There’s a serious disconnect and I think a lot of that is because people just didn’t genuinely understand what we have.”
Language can be intimidating to investors — but it doesn’t have to be. For example, here’s the name of the Phase II trials Dimerix is carrying out: “Double blind randomised placebo controlled crossover study”.
When broken down into stages the concept is a bit easier to digest.
A placebo-controlled trial provides a standardised way to test the effect on patients using the drug against those not using the drug.
And the “crossover” component means every patient receives both the placebo and a drug by the end of trial. So depending who takes the placebo or drug first, there’s a “washout” period, after which they take whatever treatment they didn’t have first time round.
“The advantage is that every person is their own control, so they’re being compared against themselves. It’s a very powerful design for a clinical trial,” Webster said.
As Dimerix pushes towards commercialisation for its products, Webster said the fact both products are new to the market adds an exciting element to the outlook — particularly in the US.
“Our product isn’t generic, it’s a new chemical entity in the US that’s never been approved,” she said.
“With that orphan designation, we’re on target to get exclusivity in the US market for a seven year period. And that means that regardless of your IP position you cannot be challenged in the marketplace, which is a huge advantage.”
Of the two products, Webster said the FSGS treatment has the inside running, having already been approved for fast-tracking by US regulators.
The other good thing about bring an orphan drug to market is that it attracts orphan drug pricing, which is “very different” to generic products.
“There’s nothing approved for FSGS treatments – the next available treatment is dialysis, where you’re looking at a price point of around $100,000,” Webster said.
Typically, new orphan drugs are priced at around 80 per cent of existing treatments, and Webster said Dimerix is targeting a price point of around $7k per month.
“The fact there’s nothing approved for an adjunct FSGS treatment means it’s an unmet need globally. So there’s certainly an advantage to get to market as quickly as we can,” Webster said.
As with any biotech, the timeline for the next round of clinical trial results is critical. Webster said the company expects results to be announced by the June quarter of next year.