BIOPHYTIS has announced that it has entered into an agreement with US firm Patheon for the industrial scale-up and manufacturing of clinical batches, the first stage of the phase 2B clinical trial for drug candidate Macuneos in AMD (age-related macular degeneration). Macuneos is a drug candidate against the dry form of AMD: AMD affects the central part of the retina, called the macula, causing severe visual impairment and irreversible loss of central vision beyond 60 years old.
Macuneos protects retinal pigment epithelium: Biophytis has shown in animal models 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.
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.
Stanislas Veillet CEO BIOPHYTIS, said: "We are very pleased to outsource the production of Macuneos to such an internationally recognized actor. This is the first stage of the MACA clinical program dedicated to treat dry AMD, a pathology with no therapeutic solution on the market so far. Our whole team is dedicated to the success of the MACA clinical project, a strategic axis of development for BIOPHYTIS."