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DatChem ยท Pharma

Objective proof of therapeutic response.

DatChem-Pharma gives drug developers an objective, biomarker-level readout of whether a therapy is working, with a response signal known within 48 hours, to support FDA, TGA and EMA submissions.

0 hrs
to a response signal
0
neurochemical pathways measured
0
engagement models
FDA / TGA / EMA
regulatory support
What it does

The chemistry of a response.

DatChem-Pharma measures the chemistry of a patient's response to a drug, providing objective proof of effect rather than a subjective impression.

It identifies which neurochemical pathways respond, for example, in ADHD, three of five pathways respond to lisdexamfetamine, making it possible to demonstrate both efficacy and mechanism from the same readout.

  • Objective proof. A biomarker-level readout of whether the therapy is working.
  • Mechanism, not just effect. Shows which pathways respond, and which do not.
  • Each patient their own control. Response is measured against the individual, not a population.
Who it's for

Built for drug developers.

DatChem-Pharma supports pharmaceutical companies developing treatments across mental health, ADHD, PTSD, pain and breast-cancer risk.

Mental health & ADHD

Demonstrate efficacy and mechanism for treatments in mental health and ADHD, pathway by pathway.

PTSD & pain

An objective readout of response for therapies addressing PTSD and pain, where subjective measures fall short.

Breast-cancer risk

Chemistry-level evidence of effect for treatments targeting breast-cancer risk.

Working together

Two engagement models.

Partner with DatChem in the way that best suits your programme, whether you run the trial yourself or hand it to us end to end.

Option 1, Data evaluation

The pharmaceutical company runs the trial, and DatChem performs the data evaluation, extracting the chemical signature and reporting the objective response.

Option 2, Trial run by DatChem

DatChem runs the whole trial in Australia, where conditions such as ADHD and PTSD are readily accommodated, from patient through to report.

Trials can run in Australia or elsewhere depending on regulatory need; human ethics approvals are required. Primary launch in the United States, followed by Australia, Germany and the EU.

How it works

From scan to objective report.

For the data-evaluation model, DatChem turns raw patient data into an objective, pathway-level readout of response.

1

Patient scan

Each patient is scanned to capture the raw spectral data, with the patient serving as their own control.

2

Data capture

Raw data is transmitted securely from the scanner to the DatChem cloud for evaluation.

3

Pathway analysis

The chemical signature is extracted to identify which neurochemical pathways respond to the therapy.

4

Objective report

A report sets out the objective response, evidence of both efficacy and mechanism for your submission.

DatChem's technologies are undergoing regulatory evaluation (TGA, FDA and EMA) and are not yet approved for routine clinical use in all markets.

Get in touch

Partner with DatChem on your trial.

For partnership, trial-design or data-evaluation enquiries about DatChem-Pharma, we'd be glad to hear from you.

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