Here are 5 ASX biotechs expecting clinical trial results in the next few months!

Here are 5 ASX biotechs expecting clinical trial results in the next few months!

Opthea (ASX:OPT)

Opthea is developing a drug called Sozinibercept (formerly known as OPT-302) that targets wet AMD, the world’s leading cause of blindness. More than five years after successful Phase 2 results, it expects to report Phase III results in the first half of next year. The company is running 2 trials with nearly 1,000 subjects in each – results from the first trial are expected in the March quarter of 2025, while the second is due in the June quarter.

The company is targeting a 5.7 letter change in BCVA from baseline at 24 weeks – essentially how many more letters can a patient read on that typical letter chart you read at your eye check ups. Success here could lead to the company seeking FDA approval. 

Recce Pharmaceuticals (ASX:RCE)

Recce has several clinical trials underway, including a recently approved Phase 3 Diabetic Foot Infection (DFI) clinical trial to be conducted in Indonesia. The Company is also about to complete a Phase 2 ABSSSI Clinical Trial (Acute Bacterial Skin and Skin Structure Infections) after dosing 20 out of 30 total patients which is expected to be completed before the end of CY24. It is important to note that this is not a trial against any one condition – the acronym ABSSI includes conditions such as DFI, necrotising fasciitis, postoperative wound infections, and more. Notwithstanding, the company has done a lot of work on several specific infections, and is bringing all its work under one key centralised regulatory category.

Interim data has shown positive results, with all patients completing treatment with Recce’s anti-infective topical gel RECCE^® 327 (R327G) having a positive primary endpoint. The Company plans to conduct a Phase 3 trial for ABSSSI in Australia in CY25, with a massive market opportunity ahead of it. The ABSSI treatment market is expected to reach US$26bn by 2032.

Island Pharmaceuticals (ASX:ILA)

Yes, this company just released data from a clinical trial, but there is another cohort that is yet to even commence treatment. Island commenced a Phase II study for its ISLA-101 drug against Dengue a couple of months ago. The study was named PROTECT, short for PROphylactic and TrEatment Challenge Trial. The trial was designed with 2 cohorts: An A cohort with 4 subjects randomised 3:1 (Active:placebo) & the B cohort (Phase 2b) that will include 10 subjects randomised 8:2 (active:placebo).

The A cohort is a prophylactic or preventative arm – meaning the analysis will be to see if ISLA-101 can prevent infections in the first place, whilst the B cohort will be an arm intended to see if ISLA-101 can treat active infections. The release of results earlier this month was from the first cohort, while the next set of results will be the second – this is expected in Q1 of 2025.

ISLA-101 offers significant hope to the world, given dengue is the most prevalent flavivirus, infecting 400m people annually; is very costly to treat and has treatments that only relieve certain symptoms.

Dimerix (ASX:DXB)

Dimerix is in the middle of a Phase III trial or its DMX-200 drug for a condition known as Focal Segmental Glomerulosclerosis (FSGS). For patients with FSGS, the kidneys’ ability to purify (clean) the blood is impaired. This can lead to kidney failure that may eventually requires dialysis or a kidney transplant.

Results from Part 1 of the trial, released in April 2024, showed positive results and paved the way to the next part of the trial. The outcome of the second interim analysis is expected by mid-CY25 and will be very crucial – being expected to generate sufficient evidence to support conditional marketing approval

There could be other catalysts beforehand, including potential licensing deals for the US and China which are bigger markets than any the company has licensed to data.

Clarity (ASX:CU6)

Clarity recently told investors the final results of its ‘DISCO Study’ would come in the first half of 2025. DISCO derives from Diagnostic Imaging Study of COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours. It will assess the performance of its SARTATE imaging product to diagnose and manage NETs (Neuroendocrine tumours).

Clarity’s technology is Targeted Copper Theranostics (TCT). Its technology platform has a bifunctional chelator (cage) at its heart that can bind and retain the copper isotopes used (in other words, stop them leaking into the body before reaching the cancer cells and causing damage to healthy cells).

The cage is linked to targeting a molecule which finds and binds tumour specific receptors on cancer cells. Unlike Telix, which focuses on multiple radioisotopes, Clarity has just two: Copper-64 and Copper 67.

Everyone knows the damage cancer does, but also that treatments such as chemotherapy can cause. The sad thing is that there has been little to no innovation in cancer treatments over the last few decades, even in spite of all the research done. But companies like Clarity provide hope.

This is a sponsored article. Dimerix and Island Pharmaceuticals have been or are research clients of Pitt Street Research. 

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