NicOx S.A. (NYSE Euronext Paris: COX) today announced that its partner Bausch+Lomb has initiated a phase 2b clinical study with BOL-303259-X, previously known as NCX 116.
BOL-303259-X is a nitric oxide-donating prostaglandin F2-alpha analog, which lowers intraocular pressure through a dual mechanism of action.
It has been developed for the potential treatment of glaucoma and ocular hypertension and was licensed to Bausch+Lomb by NicOx in March 2010.
This study is intended to identify the most effective dose of BOL‑303259‑X, administered in the evening, for the reduction of intraocular pressure (IOP).
BOL‑303259‑X has already completed two phase 2 studies in patients with glaucoma and ocular hypertension with promising results.
Data from these studies indicated that evening administration of BOL‑303259-X was more effective than morning administration.
Gavin Spencer, Vice President Business Development, commented: “Bausch+Lomb has proved to be an excellent partner, making significant progress and investment in this exciting program over the first six months of the collaboration. This has enabled the clinical development of BOL-303259-X to move ahead rapidly, and both companies believe it has the potential to become a valuable innovation in the treatment of glaucoma and ocular hypertension.”
Dr. Baldo Scassellati Sforzolini, Vice President Regulatory Affairs, Clinical & Medical Sciences at Bausch+Lomb Pharmaceuticals, commented: “Based on the data already available for BOL-303259-X, we believe there is strong rationale for bringing it to the market. In this phase 2b study, which is considerably larger than the previous phase 2 studies, we will be looking for confirmation of some key potential differentiating factors observed in earlier studies.”
The new phase 2b study is a randomized, single-masked, parallel-group dose-finding study. A total of approximately 400 patients with open-angle glaucoma or ocular hypertension will be enrolled both in the United States and in Europe.
Patients will be randomized to receive either BOL-303259-X (various concentrations) or Xalatan® 0.005% (latanoprost) for 28 days.
The primary efficacy endpoint is the reduction in mean diurnal IOP at day 28.
Secondary measures will include the reduction of mean diurnal IOP at other time points and the safety of BOL-303259-X, as compared to Xalatan®.
In March 2010, NicOx and Bausch+Lomb signed a worldwide licensing agreement for BOL-303259-X for the treatment of glaucoma and ocular hypertension.
Under the terms of the agreement, Bausch+Lomb made an initial license payment to NicOx of $10 million.
NicOx stands to receive potential development, regulatory, commercialization and sales success-based milestones, which, over time, could total $169.5 million.
NicOx will also receive tiered double-digit royalties on the sales of BOL-303259-X.
NicOx has the option to co-promote BOL-303259-X products in the United States.