• Acrux and Lumos are waiting for FDA’s approvals
  • Paradigm will present Phase 2 results
  • Neuren commences Phase 2 trials

Acrux (ASX:ACR) says the FDA has accepted its application for a generic version of coldsore treatment, ‘Acyclovir Cream, 5%’.

The FDA notified Acrux that the application is sufficiently complete to be accepted for review.

Acrux says the total addressable market for the product including existing generics exceeds US$29 million.

The company currently has three products which are actively marketed, plus three additional products which have been accepted for FDA review (including today’s Acyclovir Cream, 5%).

Lumos Diagnostics (ASX:LDX) meanwhile has filed an appeal to the US FDA regarding its decision not to grant clearance for FebriDx.

In July, Lumos announced that FebriDx was not granted the clearance by the FDA for marketing in the US.

This follows the FDA’s review of Lumos’ 510(k) application, and the FDA’s concerns regarding possible risks associated with false negative viral infection test results.

“We continue to believe that FebriDx has an important role in correctly dentifying patients who will benefit from antibiotics and, as such, has a role in initiatives to improve antibiotic stewardship,” says Doug Ward, CEO of Lumos.

“We look forward to working with the FDA to establish a regulatory path to allow us to bring FebriDx to the US market.”


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Paradigm Biopharma to present study results

A Phase 2 trial studying PPS ( pentosan polysulfate sodium ) for mucopolysaccharidosis type I (MPS-I) has returned positive results, according to Paradigm Bioppharma (ASX:PAR).

Four patients with this rare disease have been enrolled, and three have completed the 48-week treatment regimen with no serious adverse events reported to date.

PPS was well tolerated at weekly doses of 0.75 and 1.5mg/kg for 47 weeks.

Data from this clinical trial is due to be presented at ICLD (International Conference on Lysosomal Diseases) 2023 to be held in Sydney on February 20-21 next year.

Meanwhile, 50% of the planned number of patients have been recruited to the 24-week study of the MPS-VI Phase 2 trial in Brazil.

This trial will also study PPS against placebo in a blinded, randomised and controlled trial.

The MPS-I disease is a relentlessly progressive and potentially fatal rare genetic disorder, causing problems with neurological, skeletal, and cardiovascular development.

There is no cure and children born with the most severe form of MPS-I do not typically survive beyond 10 years of age.

Current standard treatments include bone marrow transplant and enzyme replacement therapy to address the underlying cause of the disease.


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Neuren commences Phase 2 trials

Neuren Pharma (ASX:NEU) says its Phase 2 clinical trials of NNZ-2591 in children with each of Phelan-McDermid syndrome (PMS) and Pitt Hopkins syndrome (PTHS) are now open for enrolment.

The first subjects are expected to enter the trials imminently at Rush University Medical Center in Chicago.

The trials are being conducted in the United States under approved Investigational New Drug applications (INDs) with the US FDA.

The trials will each enrol a single group of up to 20 children to examine safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591.

Top-line results from each trial are anticipated for H1 2023.

“These seriously debilitating conditions have no approved medicines, and we are eager to assess the potential impact of NNZ-2591, having observed highly encouraging effects in mouse models of each syndrome,” says Neuren CEO, Jon Pilcher.


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Kazia reports good Phase 1 results

Kazia Therapeutics (ASX:KZA) says interim data from the ongoing Phase I clinical trial of paxalisib has shown that all nine evaluable patients experienced complete or partial response – representing an overall response rate (ORR) of 100%.

For comparison, a typical ORR associated with whole brain radiotherapy alone can commonly range from 20-45% in published studies.

The trial is studying the combination of paxalisib and radiotherapy for the treatment of brain metastases.

Approximately 200,000 cancer patients develop brain metastases in the US each year.

They are typically very challenging to treat and are associated with poor prognosis. Radiotherapy remains a mainstay of clinical management.

The latest data has been accepted for an oral presentation at the upcoming 2022 Annual Conference on CNS Clinical Trials and Brain Metastases in Toronto.


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