Healthcare Quarterly Wrap: These biotechs are pushing for Phase 3 progress

• Australian biotechs are advancing treatments for diseases with major unmet medical needs
• Alterity secures FDA agreement on ATH434 Phase 3 trial design
• Recce advances diabetic foot infection trials and signs ANZ commercialisation deal

Special Report: Australian biotechs are making headway in developing treatments for hard-to-treat diseases, with Alterity and Recce advancing programs in neurological disease and diabetic foot infections.

Drug-resistant infections remain a major global health concern. The World Health Organisation says one in six laboratory-confirmed bacterial infections worldwide in 2023 was resistant to antibiotics.

WHO has also warned that the global pipeline of new antibiotics remains inadequate to tackle drug-resistant infections.

Multiple system atrophy (MSA) is a progressive neurological disorder that affects movement, balance and involuntary functions such as blood pressure regulation. There is currently no cure or treatment that can stop it worsening.

For biotechs targeting these unmet needs, Phase 3 trials are a critical step towards potential regulatory approval.

Here are the ASX-listed companies making progress.

Alterity Therapeutics (ASX:ATH)

ATH has FDA agreement on the design and regulatory pathway for a Phase 3 trial of its neurological treatment ATH434 in MSA.

The milestone follows Phase 2 results for ATH434 in MSA.

During the September quarter, the FDA agreed with ATH’s proposed Phase 3 trial design, including the patient population, treatment regimen and primary endpoint.

The regulator indicated that a single pivotal trial, supported by confirmatory evidence, could provide the data needed to support approval.

ATH expects its existing Phase 2 data to provide that supporting evidence.

The planned trial will enrol about 200 patients, randomised equally to receive ATH434 50mg or placebo twice daily for 12 months.

It will measure changes in patients’ ability to perform everyday activities, with preparations underway across the trial protocol, vendors, sites and drug manufacturing.

Further Phase 2 analyses presented at an international Parkinson’s disease congress in October showed ATH434 50mg slowed functional decline by about 52% compared with placebo over 52 weeks.

The analysis used statistical methods planned for Phase 3, adding to the evidence ahead of the larger trial.

ATH also secured a new US patent protecting the form of ATH434 used in its clinical trials until 2045, supporting potential future development in Parkinson’s disease.

Research from its bioMUSE natural history study found links between alpha-synuclein deposits in skin biopsies and autonomic dysfunction in MSA, potentially supporting disease monitoring.

CEO David Stamler said the FDA agreement provided clarity on the path ahead.

“With the final minutes from our End-of-Phase 2 meeting, we have confirmed alignment with the FDA on the registrational pathway for ATH434 in MSA,” he said.

“That clarity has allowed us to begin the operational start-up activities as we prepare to initiate our Phase 3 trial in MSA.”

ATH finished September with A$41.3 million in cash, supported by an approximately A$4 million R&D tax refund and about A$5.5 million raised through its listed options and underwriting arrangements.

Recce Pharmaceuticals (ASX:RCE)

RCE is advancing Phase 3 trials of its synthetic anti-infective RECCE 327 Topical Gel (R327G), targeting diabetic foot infections as it moves towards potential commercialisation.

During the September quarter, an Australian Human Research Ethics Committee approved an amended design for the pivotal Phase 3 trial.

The revised design adds a randomised, active-controlled component involving 208 patients, comparing R327G with one of four established antibiotics selected by physicians.

The study aims to show that R327G is not unacceptably less effective than existing treatments for diabetic foot infections.

Recruitment and treatment are continuing in Australia, with an interim analysis planned after 104 participants have been enrolled, randomised, treated and followed to the end of treatment or withdrawn from the study.

RCE’s parallel Phase 3 program in Indonesia is approaching a key data review.

After quarter-end, RCE submitted a 75-patient dataset to an Independent Data Monitoring Committee for unblinded evaluation. The committee may meet as early as mid-November 2026, while the company, investigators and patients remain blinded.

The committee’s recommendations could range from progressing towards regulatory submission to continuing, modifying or halting the study.

RCE signed a binding exclusive licensing and commercialisation agreement with Arrotex Pharmaceuticals after quarter-end, covering R327G in Australia and New Zealand.

The deal provides a potential route to market if the treatment secures regulatory approval.

RCE also secured a Vietnamese patent for its synthetic anti-infective technology, with protection extending to 2041.

In the US, RCE highlighted opportunities linked to a new government medical countermeasures strategy that identifies broad-spectrum antimicrobials as a funding priority.

The strategy aligns with RCE’s existing US Army research collaborations and US$2 million research grant, although no additional funding has been secured.

RCE completed an A$2.4 million share purchase plan, taking total proceeds from its placement and SPP to A$6.4 million before costs.

It also received a further A$3.6 million R&D tax rebate, taking total FY2025 rebates to about A$8.9 million.

At Stockhead we tell it like it is. Alterity Therapeutics and Recce Pharmaceuticals are Stockhead advertisers.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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