November 2022 • PharmaTimes Magazine • 7
// CLINICAL TRIALS //
XBiotech has announced the enrolment of the first patient in a multicentre, randomised clinical study for Natrunix. The treatment will be analysed in combination with trifluridine and tipiracil for the treatment of colorectal cancer.
The clinical study for XBiotech’s candidate cancer treatment is being funded by the French National Cancer Institute (INCA).
Subjects receiving the experimental therapy have previously failed earlier treatment with oxaliplatin, irinotecan and fluoropyrimidine.
Meanwhile, participants are randomised to receive Natrunix plus chemotherapy or placebo and chemotherapy. The research is designed to seamlessly proceed through phase 3 development based on achievement of certain efficacy milestones in the phase 1 and phase 2 portions.
Colorectal cancer is one of the most common cancer in Europe and the US.
Asarina has completed the recruitment of patients to its phase 2a clinical study in Tourette syndrome with a total of 28 patients enrolled.
The study compound, Sepranolone, is an endogenous neurosteroid – an entirely new treatment modality for Tourette. It has demonstrated a strong safety prolife in multiple previous clinical studies and reduced tics without inducing any of the motor side effects from previous preclinical studies.
Enrolment of adult patients started at the Bispebjerg University Hospital in Copenhagen in February 2022, while teenage patients have been enrolled at the Danish National Center for Tourette at Herlev University Hospital since summer 2022.
Until now, a total of 13 patients have completed the study. Last-patient-last-visit remains scheduled for January 2023 with top line results expected at the end of March 2023.
The study has had an unexpectedly low dropout rate with only two patients having departed the research. In most clinical studies, the highest dropout rates tend to come from the ‘active dose’ group rather than from the control group.
Arecor has announced headline results from the second phase 1 clinical trial of its ultra-rapid acting insulin, AT247, which supports the facilitation of a fully closed loop artificial pancreas.
AT247 is an ultra-rapid acting novel formulation of insulin that has been designed to accelerate the absorption of insulin post-injection. The superior pharmacokinetics (PK) and pharmacodynamics (PD) profile of a single AT247 dose, compared with gold standard insulins NovoLog and Fiasp, has been previously demonstrated in a phase 1 study.
This second clinical study further confirms that AT247 has a superior PK profile compared with NovoLog and Fiasp – showing a statistically significant difference when meeting the trial’s co-primary endpoint.
AT247 also demonstrated a statistically superior early glucose lowering effect in the trial’s second primary endpoint compared with NovoLog. The trial further demonstrated that AT247 can be safely and effectively delivered via continuous SC infusion using an insulin pump.
With a superior PK profile and promising PD results, this study supports the potential that AT247 can enable even more effective disease management for people with type 1 diabetes using fully automated delivery of insulin via a pump in closed loop mode.