September’s top news stories

5th October 2019 (Last Updated October 10th, 2019 16:17)

NIH kick starts hunt for neuroprotective stroke treatments and Denali begins dosing Parkinson’s patients in Phase Ib trial. Clinicaltrialsarena.com wraps up the key headlines from September 2019.

September’s top news stories
AXO-Lenti-PD is an investigational gene therapy being developed for the treatment of Parkinson’s disease. Credit: Colin Behrens from Pixabay.

NIH kick starts hunt for neuroprotective stroke treatments

The US National Institute of Health (NIH) launched a search for neuroprotective therapies to reduce ischemic brain injury.

The NIH will fund a preclinical trial platform that will test treatments for ischemic stroke in rodents. Over the next three years, it will give $4m for the network.


Denali begins dosing Parkinson’s patients in Phase Ib trial

Denali Therapeutics started dosing patients in a Phase Ib clinical trial evaluating DNL151 for the treatment of Parkinson’s disease.

DNL151 is a small molecule leucine-rich repeat kinase 2 (LRRK2) inhibitor. LRRK2 regulates lysosomal function and its inhibition is expected to restore the impaired function and slow disease progression in Parkinson’s patients.

The multi-centre, randomised, placebo-controlled, double-blind Phase Ib study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of various oral doses of the drug candidate over 28 days.


Amgen’s KRAS-targeting cancer drug yields favourable results

Amgen reported additional results from the Phase I clinical trial of its investigational cancer drug AMG 510, which irreversibly targets the KRASG12C protein.

The open-label, multi-centre study involved patients with KRAS G12C-mutated solid tumours who previously received a minimum of two or more lines of therapy.

It assessed a once-daily, oral 180mg, 360mg, 720mg and 960mg dose of AMG 510.


Janssen reports positive results from trials of esketamine nasal spray

The Janssen Pharmaceutical Companies of Johnson & Johnson reported positive results from two Phase III trials that evaluated the safety and efficacy of esketamine nasal spray to treat adult patients with major depressive disorder (MDD).

The pivotal double-blind, randomised, placebo-controlled, multi-centre ASPIRE I & II trials met their respective primary efficacy endpoint of a reduction in depressive symptoms at 24 hours after the first dose as measured under the Montgomery-Åsberg Depression Rating Scale (MADRS).


Signant Health to assist Shanghai Mental Health Center in trial

Shanghai Mental Health Center (SMHC) selected Signant Health to provide electronic informed consent for a neuroscience study on schizophrenia.

The investigator-led trial will enrol patients at different sites in the country and will use Signant’s TrialConsent solution.


SU2C to support clinical trials in breast and prostate cancers

Charity organisation Stand Up To Cancer (SU2C) launched two research teams to support clinical trials involving patients with breast or prostate cancer.

The trials will be conducted in alliance with Roche subsidiary Genentech, which will supply cancer immunotherapy drug atezolizumab (Tecentriq) and ipatasertib.

Atezolizumab holds US Food and Drug Administration (FDA) approval in select forms of metastatic bladder, lung and breast cancers, while ipatasertib is still in clinical development.


Cosentyx meets Phase III goals in axial spondyloarthritis patients

Novartis reported additional data from the ongoing Phase III PREVENT clinical trial of Cosentyx (secukinumab), where all primary and secondary endpoints were met in patients suffering from non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx is a fully-human biologic designed for the direct inhibition of interleukin-17A (IL-17A), which is associated with psoriatic arthritis (PsA), psoriasis (PsO) and ankylosing spondylitis (AS).

The two-year randomised, double-blind, placebo-controlled PREVENT trial evaluated the safety and efficacy of Cosentyx in 555 adults with active nr-axSpA, including 501 biologic naïve subjects.


Trial evaluates senolytic drugs to treat kidney disease

A trial by Mayo Clinic in the US evaluated the safety and feasibility of senolytic drugs for the treatment of diabetes-related kidney disease.

According to the study results, the drugs were able to remove senescent cells from the human body. The result was confirmed using blood analysis and with changes in senescent cell abundance within the skin and fat tissue.

Senescent cells are known to build up with ageing and in organs affected by chronic diseases.


Wistar secures funds for clinical studies on opioid use in HIV patients

The Wistar Institute in the US received more than $12m in funding from the National Institute on Drug Abuse (NIDA) to support a clinical research consortium focused on opioid use in HIV patients.

The international consortium will evaluate the effect of opioid use disorder (OUD) and related medicines on immune recovery triggered by antiretroviral therapy (ART).

HIV infection and also chronic opioid exposure are linked to immune activation that causes depletion of T cells and progression to acquired immunodeficiency syndrome (AIDS).


Innate Pharma announces Phase III clinical trial of monalizumab

Innate Pharma announced that its partner AstraZeneca will advance monalizumab into a Phase III randomised clinical trial.

The Phase III clinical trial will evaluate the safety and efficacy of monalizumab in combination with cetuximab in patients with squamous cell carcinoma of the head and neck (SCCHN).

Monalizumab is a potential checkpoint inhibitor targeting NKG2A receptors expressed on tumour-infiltrating cytotoxic CD8+ T cells and NK cells while cetuximab is an anti-EGFR monoclonal antibody.