Accure Therapeutics enrols first patient in the phase II clinical trial on acute optic neuritis with its lead candidate ACT-01
Accure Therapeutics, a private translational R&D engine at clinical stage in the Central Nervous System (CNS) field, has announced the enrollment of the first patient in ACUITY phase II clinical trial on acute optic neuritis with its lead candidate ACT-01. The biotechnological company, based in the Barcelona Science Park and boosted by the Accelerator Programme of GAEM Foundation, expects results in the second half of 2022.
The ACUITY study is carried out within the neurology-opthalmology network of the Assistance Publique-Hôpitaux de Paris (AP-HP), with the leading site at Hôpital Pitie-Salpêtrière. The trial is under the supervision of lead investigator Dr. Céline Louapre, from the Institut du Cerveau et de la Moelle épinière (Institut du Cerveau – ICM), and scientific advisor Dr. Sophie Bonnin, from the Pitié-Salpétrière.
“This study is set to confirm the safety and tolerability of Accure’s candidate and to provide preliminary proof-of-efficacy – both as clinical and imaging evidenced by optical coherence tomography (OCT) – of ACT-01 in patients living with inflammatory demyelinating diseases such as acute optic neuritis,” said Dr. Celine Louapre. “These first efficacy results in patients will give us an estimate of the treatment effect and help us calculate the adequate sample size for the next clinical study.”
Preliminary efficacy of ACT-01 will be assessed over a six month period – post onset of AON symptoms. By this time, almost all subjects are expected to have come to the end of their natural recovery; therefore this strategic timeline is used to compare the profiles of disease progression, and structural and functional outcomes between subjects in each treatment arm. For the majority of patients, thinning of the retinal layers in the affected eye occurs within the first six months of the onset of AON, as measured by the RNFL- retinal nerve fiber layer and the GCIPL – ganglion cell-inner plexiform layer, in an OCT scan.