Date: 2017-07-19
Type of
information: Initiation of development program
phase: 1-2
Announcement:
Company: Biophytis (France)
Product: Macuneos (formerly BIO201)
Action
mechanism: PPAR agonist. Macuneos (formerly BIO201) is an agonist of nuclear receptor PPAR. It protects retinal pigment epithelium. In animal models Biophytis has shown a protection of retinal cells against phototoxic effects of A2E in the presence of blue light (oxidative stress), a reduction in accumulation of A2E, and eventually a slowdown of the degenerative process of the retina.
Disease: age related macular degeneration (AMD)
Therapeutic
area: Ageing diseases - Ophtalmological diseases
Country: Belgium, France
Trial
details:
- The MACA-OBS and MACA-PK studies are complimentary studies preparing for the MACA-INT interventional study. They will allow the preselection of 15 clinical ophthalmological centers in Europe and the USA and the pre-recruitment of patients with mild dry AMD who could be included, if they give their consent, into the MACAINT interventional study. This international study will begin in the second half of 2018 and should conclude in 2021. It will involve more than 300 subjects aged over 50 with mild dry AMD, distributed between twenty clinical centers. The objective of MACA-INT is to determine the effective treatment dose of Macuneos, limiting the increase in size of the geographic atrophy in patients with mild dry AMD.
The key steps of the MACA program are as follows:
- - H2 17: MACA-PK SAD: Pharmacokinetics study in healthy volunteers (ending H2 17)
- H2 17: MACA-OBS: Initiation of observational phase (ending H1 18)
- H1 18: MACA-PK MAD: Pharmacokinetic study on patients (ending H1 18)
- H2 18: MACA-INT: Initiation of interventional Phase 2b
- H2 21: MACA-INT: Results report of Phase 2b
- The MACA-PK study is a phase I/IIa clinical study, whose protocol has been optimized to study the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers in a Belgian clinical center in 2017 as originally planned, and in patients suffering from dry AMD recruited in 5 ophthalmological centers in France and in Belgium, including the CIC of l’Hôpital des Quinze-Vingt in Paris, in 2018.
- The multicentric observational MACA-OBS study aims at characterizing the target population and preselecting
patients with dry AMD. For a period of 6 months, this study will involve one hundred patients with mild AMD
distributed between 9 centers in Europe and the USA, including the Massachusetts Eye and Ear Infirmary
(Harvard Medical School) in Boston. The regulatory authorizations for opening the centers are expected in the
second half of 2017, thus allowing the start of MACA-OBS and following that, the recruitment of patients.
Latest
news:
- • On July 19,2017, Biophytis has announced the contracting of Appletree CI Group to conduct the MACA-OBS clinical study of its drug candidate Macuneos in the treatment of age-related macular degeneration (AMD). The objective of the MACA-OBS observational study is to characterize the target population and to preselect patients with dry AMD.
- Biophytis is waiting to be granted the regulatory authorizations in the second half of 2017 in order to open centers in Europe and the USA. Alongside MACA-PK, MACA-OBS is intended to prepare for the phase 2b MACA-INT interventional study which should be launched during the second half of 2018.
- Appletree CI Group will provide its clinical research
services and will also support Biophytis with regards to filings at the agencies in Europe and more widely at the
international level.
- • On June 15, 2017, Biophytis has announced the contracting of SGS Life Science Services to conduct the MACA-PK clinical study of its drug candidate Macuneos in the treatment of age-related macular degeneration (AMD).
- • On October 24, 2016, Biophytis announced that it has entered into an agreement with Patheon for the industrial scale-up and manufacturing of clinical batches of Macuneos
- As part of the agreement, Patheon will be in charge of the industrial scale-up and manufacture of Macuneos clinical batches. These lots will be used by Biophytis for the Phase 2B study MACA, to be launched in Europe and the United States once all approvals of regulatory authorities have been obtained.
Is
general: Yes
