BIOPHYTIS Chooses Patheon to Produce Clinical Batches

BIOPHYTIS recently announced 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 IIB 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 IIB study MACA, to be launched in Europe and the United States once all approvals of regulatory authorities have been obtained.

“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,” said Stanislas Veillet, CEO of BIOPHYTIS.

The MACA Phase IIB trial will involve 300 patients over 50 years of age with intermediate dry form of AMD, and should involve 20 centers in Europe and 10 in the United States. Patients enrolled in the study will be divided into three cohorts: Macuneos 100 mg, Macuneos 350 mg, and placebo. The investigation period will be 18 months, with an intermediate checkpoint after 9 months.

The study will begin with a preparatory phase, including a pharmacokinetics and safety study will be conducted in Europe among healthy elderly volunteers (the MACA-PK study), and a pilot characterization study of the target population and a pre-selection of patients suffering from dry AMD in major recruitment centers in Europe and the US (the MACA-OBS study).

BIOPHYTIS SA (www.BIOPHYTIS.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing next year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute.