June’s top news stories

8th July 2019 (Last Updated August 9th, 2019 06:35)

AstraZeneca’s human monoclonal antibody Imfinzi (durvalumab) improved overall survival in the Phase III CASPIAN trial in first-line extensive-stage small cell lung cancer (SCLC).

June’s top news stories
Micrograph of small cell carinoma of the lung, also small cell lung cancer. Credit: Nephron.

AstraZeneca reports positive results from CASPIAN trial of Imfinzi

AstraZeneca’s human monoclonal antibody Imfinzi (durvalumab) improved overall survival in the Phase III CASPIAN trial in first-line extensive-stage small cell lung cancer (SCLC).

The trial showed positive overall survival (OS) results from the CASPIAN trial in SCLC, a disease with a significant unmet need and limited treatment options.

An Independent Data Monitoring Committee conducted a planned interim analysis and concluded that the trial met its primary endpoint.


Acceleron completes enrolment for PULSAR trial of sotatercept

Acceleron Pharma completed enrolment for the PULSAR Phase II trial of sotatercept to treat patients with pulmonary arterial hypertension (PAH).

The PULSAR trial enrolled a total of 100 patients with PAH, a rare and chronic disorder caused due to the contraction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation.

Additional patients who are currently undergoing screening will be eligible to be randomised into the trial over the next few weeks.


Lilly reports positive results from trial of diabetes drug Trulicity

Eli Lilly and Company reported that the AWARD-11 Phase III trial of Trulicity (dulaglutide) met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes.

The trial is studying higher investigational doses of Trulicity compared to once-weekly Trulicity 1.5mg after 36 weeks.

Additionally, the trial met the secondary efficacy endpoint for superiority on weight reduction.


ILiAD initiates Phase IIb trial of pertussis vaccine BPZE1

ILiAD Biotechnologies initiated the Phase IIb IB-200P clinical trial of BPZE1, a live attenuated intranasal vaccine to treat pertussis, a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis.

The multi-centre, randomised, placebo-controlled, and observer-blinded study will study BPZE1 in healthy adults to assess the immunological response and safety profile of single and two dose vaccination schedules.

For this trial, ILiAD will enrol about 300 subjects who will be randomly assigned 2:1 for the first (primary) vaccination.


BioPharmX reports positive results from BPX-041 trial for rosacea

BioPharmX reported positive results from its Phase IIb trial of BPX-041 for the treatment of moderate-to-severe papulopustular rosacea, a chronic dermatologic condition characterised by redness, stinging, and inflammatory lesions primarily on the face.

The company enrolled the first subject in October last year to study BPX-04, a novel topical gel formulation of fully solubilised minocycline and a 1% minocycline gel.

The randomised, double-blind, vehicle-controlled Phase IIb trial has successfully met both the primary and secondary endpoints.


Asieris concludes enrolment for Phase Ib trial of APL-1202

Chinese biotech company Asieris Pharmaceuticals completed enrolment for its Phase Ib trial in the US to evaluate the safety, tolerability, and PK characteristics of APL-1202.

APL-1202 is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor and is currently being developed to treat non-muscle invasive bladder cancer (NMIBC), one of the most common malignant tumours.

The drug has novel mechanisms of action of inhibiting tumour cell growth, as well as angiogenesis.


BMS’ trial of HCC drug fails to meet primary endpoint

Bristol-Myers Squibb’s (BMS) CheckMate -459 Phase III clinical trial of Opdivo (nivolumab) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) failed to meet the primary endpoint of overall survival (OS).

The randomised, multi-centre Phase III study evaludated Opdivo versus sorafenib as a first-line treatment for HCC, the most common type of liver cancer. No new safety signals were observed with Opdivo in the trial.

BMS noted that the results showed a clear trend towards improvement in OS for patients treated with Opdivo compared to sorafenib.


FDA lifts partial clinical hold on AbbVie’s trial of venetoclax

The US Food and Drug Administration (FDA) lifted the partial clinical hold placed on AbbVie’s CANOVA (M13-494), a Phase III trial evaluating venetoclax to treat relapsed / refractory multiple myeloma.

In March this year, the FDA placed a clinical hold on all trials evaluating venetoclax following a review of data from the Phase III BELLINI trial in relapsed / refractory multiple myeloma.

Venetoclax is being developed by AbbVie and Roche.

AbbVie said that a higher proportion of deaths were observed in the venetoclax arm of the study when compared to the control arm.


Motif Bio unveils new iclaprim data for skin disorders

Motif Bio presented new data for antibiotic drug candidate iclaprim at the American Society for Microbiology (ASM) Microbe 2019 meeting in San Francisco, US.

The British clinical-stage biopharmaceutical company claimed that the pharmacokinetic analysis showed an improvement in efficacy parameters and Cmax with iclaprim fixed-dose used in the Revive Phase III trials in acute bacterial skin and skin structure infections (ABSSSI).

The data was compared to the weight-based dose used in the earlier Assist trials for complicated skin and skin structure infections (cSSSI).


Genkyotex announces positive final results of GKT831 trial in PBC

Genkyotex reported positive final results of its Phase II trial of anti-fibrotic candidate GKT831 in primary biliary cholangitis (PBC).

This data includes pre-determined secondary efficacy analyses that were not available earlier, in addition to full safety data.

The trial’s efficacy results demonstrate that when 400mg GKT831 was administered twice a day (BID), statistically significant reductions were achieved in gamma glutamyl transpeptidase (GGT) (p<0.002) and alkaline phosphatase ALP) (p<0.001) compared to placebo over the treatment period for 24 weeks.