Nicox SA provided Q1 2020 operational highlights, revenue and cash position for Nicox SA and its subsidiaries, as well as updating key expected milestones in 2020.
Key Expected Upcoming Milestones
- NCX 470 Mont Blanc Phase 3 clinical trial: The first phase 3 clinical trial of NCX 470 for lowering of IOP in patients with open-angle glaucoma or ocular hypertension is currently expected to start by the end of Q2 2020, with topline results expected in Q3 2021. The Mont Blanc trial will be conducted principally in clinical sites in the U.S. and will include a small number of Chinese clinical sites. The trial will be initiated with 0.065% and 0.1% doses of NCX 470 vs. latanoprost 0.005%, with only one dose of NCX 470 being selected through an adaptive design to complete the trial.
- NCX 470 Denali Phase 3 clinical trial: The second phase 3 glaucoma clinical trial, jointly managed and equally funded by Nicox and Ocumension, is currently expected to start in H2 2020. It will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S. to support the U.S. New Drug Application (NDA) filing. A sufficient number of patients from China will be included in the Denali trial to support an NDA filing in China.
- NCX 4251 Phase 2b clinical trial: This phase 2b trial will include both blepharitis and dry eye endpoints with the option of declaring either acute exacerbations of blepharitis endpoint or dry eye endpoints as the primary outcome of the trial. Timing and further trial design details will be announced in due course.
- Zerviate China: A phase 3 clinical trial for approval in China, to be conducted and financed by Ocumension, is currently expected to start by Q4 2020.
Nicox continues to closely watch the spread of COVID-19 and its impact around the world. The company does not currently anticipate delays to our clinical timelines but is monitoring the situation and will provide updates in due course if there is an impact on our development projects and timelines.
First Quarter 2020 and Recent Operational Highlights
- The total number of prescriptions1 for Vyzulta (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the first quarter of 2020 increased by 11% compared to the fourth quarter of 2019 and by 60% compared to the first quarter of 2019.
- Successful end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design for the NCX 470 Phase 3 program, as well as nonclinical and CMC plans supporting submission of an NDA in the U.S. NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, is Nicox’s lead clinical development program.
- Successful Type C meeting with the FDA and agreement on phase 2b trial designs for NCX 4251 in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease. NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is Nicox’s second product candidate in clinical development. The timing of the future program for NCX 4251 is subject to securing the financial resources to advance its development.
- Zerviate (cetirizine ophthalmic solution), 0.24%, launched in the U.S. by our partner, Eyevance, creating an additional recurrent revenue stream. Zerviate is the first novel prescription-only treatment for allergic conjunctivitis in over 10 years and is being marketed by the Eyevance commercial team, which currently covers 40 key territories in the U.S.
- Amendment of NCX 470 agreement with Ocumension where Ocumension paid €15 million (in replacement of the totality of the milestones in the original agreement), gained additional exclusive rights to NCX 470 for Korea and Southeast Asia and will pay 50% of the costs of the second glaucoma phase 3 clinical trial of NCX 470 (‘Denali’). The two companies will jointly manage the Denali trial in the U.S. and China.
- Amendment of Zerviate license agreement with Ocumension, extending the exclusive rights to include the majority of the Southeast Asian region.
- Following results from in vivo primary pharmacodynamics studies of naproxcinod in models of sickle-cell disease, U.S. partner Fera Pharmaceuticals decided to focus its development of naproxcinod on the treatment of painful vaso-occlusive crisis in sickle-cell disease. Fera plans to conduct further studies and other development activities in preparation for entering directly into a clinical efficacy trial of naproxcinod in sickle-cell patients, subject to being granted an ODD.
- Approval from the U.S. Patent and Trademark Office and from the Japanese Patent Office of a formulation patent for NCX 470, extending the patent coverage to 2039 in those countries.
- Exclusive global partner Bausch + Lomb received approval for Vyzulta in Argentina, Mexico, Hong Kong and Taiwan, bringing the total number of countries or territories where Vyzulta is approved for commercialization to six.