January’s top news stories

TITAN trial aims to Erleadain combination with androgen deprivation therapy in patients with mCSPC. Credit: Photo by Paweł Czerwiński on Unsplash. PET scan of a healthy brain compared to a brain at an early stage of Alzheimer’s disease. Credit: Institut Douglas. Nail displaying the characteristic pitting of psoriasis. Credit: Seenms. Janssen Pharmaceutical Companies of Johnson & Johnson unblinded the Phase III TITAN trial investigating Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The development follows recommendation provided by an Independent Data Monitoring Committee (IDMC) and a pre-planned evaluation that showed that the trial achieved its dual primary endpoints of improving radiographic progression-free survival (rPFS) and overall survival (OS).

IDMC suggested that patients in the placebo plus ADT group should be allowed to cross over to treatment with Erleada plus ADT. However, the TITAN trial will continue to follow patients for OS and long-term safety results.

Genentech decided to suspend the CREAD 1 and CREAD 2 trials designed to study crenezumab in patients with early (prodromal to mild) sporadic Alzheimer’s disease (AD).

The decision is the result of data gained from a pre-planned interim analysis carried out by an Independent Data Monitoring Committee on the safety and efficacy of crenezumab.

The evaluation showed that crenezumab is unlikely to meet the trials’ primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.

Novartis reported positive results from a pooled analysis of four Phase III clinical trials evaluating Cosentyx (secukinumab) in patients with moderate-to-severe plaque psoriasis (PsO).

PsO is characterised by painful red, raised, dry patches of skin and usually attacks extensor areas of the forearms and shins as well as the scalp, palms of the hand, soles of the feet and fingernails.

Cosentyx is a fully human IL-17A antagonist approved to treat moderate to severe PsO, psoriatic arthritis (PsA), and ankylosing spondylitis (AS).

Scientists from the National Institute of Allergy and Infectious Diseases (NIAID) started vaccinations in a Phase I clinical trial to evaluate ID93 for the treatment of tuberculosis (TB).

ID93 is a freeze-dried, temperature-stable TB vaccine candidate developed by scientists at the US Infectious Disease Research Institute (IDRI).

The Phase I trial is designed to investigate the safety, tolerability, and immunogenicity of single-vial formulation ID93 and GLA-SE vaccine.

CStone Pharmaceuticals received approval from China’s National Medical Products Administration (NMPA) for its clinical trial application (CTA) to begin a Phase I clinical trial of BLU-554 (CS3008) for the treatment of hepatocellular carcinoma (HCC).

HCC is the most common form of liver cancer and is estimated to affect around 466,000 people and cause 422,000 deaths annually in China.

BLU-554 is a fibroblast growth factor receptor 4 (FGFR4) inhibitor developed by CStone’s partner Blueprint Medicines.

Navitor Pharmaceuticals commenced Part B of its Phase I clinical trial investigating NV-5138 for treatment-resistant depression (TRD).

NV-5138 is an orally-active small molecule designed to directly activate cellular metabolism modulator mTORC1, which is usually suppressed in the brain of people suffering from depression.

The trial is designed to study the safety, tolerability, and pharmacokinetics of NV-5138 in up to 88 healthy patients with TRD.

Amgen and Allergan reported positive top-line results from a Phase I/III trial of ABP 798 in comparison with rituximab for the treatment of patients with moderate-to-severe rheumatoid arthritis.

ABP 798 is currently being studied as a biosimilar candidate to Rituxan (rituximab), a CD20-directed cytolytic antibody that is approved in various regions for the treatment of moderate-to-severe rheumatoid arthritis and other conditions.

The newly published data showed that the trial met its primary objective of pharmacokinetic (PK) similarity.

Athersys reported positive results from a trial evaluating MultiStem cell therapy for the treatment of patients with acute respiratory distress syndrome (ARDS).

Initial data from the double-blind, randomised, placebo-controlled portion of the trial demonstrated that 25% of patients treated with MultiStem achieved a lower mortality rate than the 40% of patients treated with placebo.

It was also found that patients in the MultiStem treatment group achieved higher ventilator-free (VF) days and ICU-free days compared to the patients in the placebo group.

Second Genome dosed the first patient in a Phase II clinical trial assessing SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH), a subtype of nonalcoholic fatty liver disease (NAFLD).

SGM-1019 is an oral, small molecule inhibitor of the P2X7 receptor that can activate inflammasome, and mediate inflammation and fibrosis.

The company intends to enrol 100 patients at sites across the US for the randomised, double-blind, placebo-controlled trial.

Unity Biotechnology expanded its ongoing Phase I trial to evaluate UBX0101 in patients with moderate to severe osteoarthritis (OA) of the knee.

The company added a new cohort of 24 patients to examine 4mg UBX0101, the highest evaluated dose.

The Part B expansion is designed to complement the initial Part A of the trial and will further analyse the impact of UBX0101 on certain pro-inflammatory and extracellular matrix modifying factors within the Senescence-Associated Secretory Phenotype (SASP).

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