July’s top news stories

6th August 2018 (Last Updated August 6th, 2018 00:00)

The Kyoto University’s Centre for iPS Cell Research and Application (CiRA) in Japan is to start two clinical trials that will evaluate human induced pluripotent stem cells (iPS) to treat Parkinson’s disease, and Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), along with Parkinson’s UK, announced that the European Medicines Agency (EMA) issued a positive qualification opinion on biomarker as a tool to boost clinical trials on Parkinson’s. Drugdevelopment-technology.com wraps up the key news stories from July 2018.

Kyoto University to begin trials of iPS cells to treat Parkinson’s

Kyoto University’s Centre for iPS Cell Research and Application (CiRA) in Japan is to start two clinical trials that will evaluate human-induced pluripotent stem cells (iPS) to treat Parkinson’s disease.

One of the Kyoto trials will evaluate the safety and efficacy of iPSC-derived dopaminergic progenitors to treat Parkinson’s.

The Phase I/II trial aims to investigate the safety and efficacy of transplanting human iPS cell-derived dopaminergic progenitors into the putamen of Parkinson’s disease patients.


EMA issued positive opinion on biomarker for Parkinson’s trials

Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), along with Parkinson’s UK, announced that the European Medicines Agency (EMA) issued a positive qualification opinion on biomarker as a tool to boost clinical trials on Parkinson’s.

The aim of this biomarker is to act as a measurement that can be used to choose people with Parkinson’s who are most suitable for clinical trials.

It helps to determine the presence of dopamine transport deficiency in the brain.


Immunicum received approval for ilixadencel and CPI Phase Ib/II trial

Immunicum received protocol approval from the US Food and Drug Administration (FDA) to begin the ILIAD Phase Ib/II trial to investigate the safety and efficacy of intratumorally administered ilixadencel in combination with checkpoint inhibitors (CPIs) for three types of cancer indications.

The indications include head and neck cancer, non-small cell lung cancer, and gastric and gastroesophageal junction adenocarcinoma.

The newly granted approval allowed Immunicum to start the process of patient enrolment for the trial, which is expected to include the first patient in the second half of this year.


Takeda reported positive top-line outcomes from VISIBLE 1 trial

Takeda Pharmaceutical Company reported positive top-line results from the VISIBLE 1 trial after meeting its primary endpoint.

VISIBLE 1 is a pivotal Phase lll, randomised, double-dummy, double-blind, placebo-controlled trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy for the treatment of moderately to severely active ulcerative colitis (UC).

The trial enrolled 384 patients who had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumour necrosis factor-alpha (TNFα)-antagonist therapy before being enrolled.


Bristol-Myers Squibb and Gritstone to start Phase l trial for tumours

Bristol-Myers Squibb Company entered a clinical trial collaboration with Gritstone Oncology to examine the safety and tolerability of GRANITE-001 in combination with Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) for the treatment of patients with advanced solid tumours.

Under the collaboration, Gritstone Oncology will sponsor the two-part dose-escalation trial, which is scheduled to begin later this year.

As a part of the trial, the combination of GRANITE-001 will be examined with systemic Opdivo and a localised subcutaneous injection of Yervoy.


Roche reported positive interim data from Mpower132 trial

Roche reported a positive outcome from the IMpower132 study after an interim analysis showed that the trial met one of its co-primary endpoints of progression-free survival (PFS).

IMpower132 is a Phase III, open-label, randomised trial designed to analyse the efficacy and safety of Tecentriq (atezolizumab) in combination with chemotherapy, including cisplatin or carboplatin and pemetrexed versus chemotherapy alone for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC).

The trial enrolled 578 chemotherapy-naïve patients with advanced NSCLC.


Asana started Phase llb trial of ASN002 for atopic dermatitis

Asana BioSciences commenced the RADIANT Phase llb trial to investigate the efficacy, safety, tolerability, and pharmacokinetics of ASN002 to treat patients with moderate-to-severe atopic dermatitis (AD).

The randomised, double-blind, placebo-controlled trial is expected to enrol around 220 adult patients diagnosed with chronic atopic dermatitis for at least six months with an eczema area and severity index (EASI) score of 16 or more.

The patients will also be required to have an investigator’s global assessment (IGA) score of three or greater, and a body surface area involving at least 10% at baseline.


Pfizer and Eli Lilly reported positive results from Phase III tanezumab

Pfizer and Eli Lilly and Company reported positive results from a Phase lll trial evaluating the efficacy and safety of tanezumab to treat patients with osteoarthritis (OA) of the knee or hip.

The 16-week, randomised, double-blind, placebo-controlled, multicentre, parallel-group trial compared the subcutaneous administration of tanezumab against placebo.

A 24-week safety follow-up period was also included in the trial that enrolled a total of 698 patients with moderate-to-severe OA pain who had experienced inadequate pain relief with other treatment options for OA pain or were unable to take other pain medications.


Abivax completed dosing in ABX464-101 trial for UC

Abivax completed dosing patients in the ABX464-101 trial, a Phase lla clinical trial investigating the safety and efficacy of ABX464 to treat patients with ulcerative colitis (UC).

The randomised, double-blind, placebo-controlled, proof-of-concept trial has enrolled 32 patients with moderate-to-severe active UC who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids.

The patients have been randomised in a 2:1 ratio to receive a once-daily dose of ABX464 at 50mg or placebo for two months.


Blade Therapeutics started Phase l trial of BLD-2660 for fibrosis

Blade Therapeutics commenced a Phase l clinical trial to investigate the safety and pharmacokinetics (PK) of BLD-2660 for the treatment of fibrosis.

Fibrosis is the development of additional fibrous connective tissue in an organ or tissue in a reparative or reactive process.

As part of the first-in-human, placebo-controlled, dose-escalation Phase l trial, BLD-2660 will be orally administered to healthy subjects.