OP-01 Foam Platform

Foam treatments such as OP-01 are becoming more prominent delivery systems for topical drugs due to the intrinsic advantages of the platform: easy and fast application, product visibility after application, complete coverage of large and variable surface areas as the product expands and molds to the unique shape of the patient. In addition, foam applications can remain in place for longer periods of time, increasing residence time of drugs at target sites. Finally, foam-based ear products can be administered while the patient is standing or sitting and do not require any special or uncomfortable applications of the treatment.

First-Generation Formulation

We conducted four clinical trials of our first generation (antibiotic only) formulation of OP-O1 and believe the results support the utility of OP-01. Data from the most recent clinical trial was announced in January 2015. The study was a 220 patient, phase 2, randomized, multicenter, parallel, active comparator trial in 220 acute otitis externa (AOE) patients ages six months and older. During this trial, OP-01 which contains 0.3% ciprofloxacin was administered once-daily for 7 days (7 doses) while the active comparator (CIPRODEX®), which contains 0.3% ciprofloxacin and 0.1% dexamethasone was administered twice-daily for 7 days (14 doses). The primary endpoint of the study was clinical cure, defined as score = 0 for erythema, edema, tenderness, ear discharge (otorrhea), and no further antibiotic required. Safety and efficacy of OP-01 was found to be similar (non-inferior) to CIPRODEX®, even though OP-01 contained no steroid and utilized 50% fewer doses over the week-long course of therapy.

Second-Generation Formulation

In 2016, we stopped further development of the first-generation, antibiotic-only product and began development of a second-generation formulation of OP-01 which will include both an antibiotic plus a second active ingredient to address ear pain. The goal for this second-generation OP-01 formulation is to produce a clinically differentiated product that rapidly resolves ear pain (an unmet need in AOE), as well as eradicates the infection with fewer than 7 days of dosing. We believe a product of this nature would meaningfully improve upon the standard of care and may become a best-in-class treatment option for AOE. In 2017, Novus made the strategic decision to focus substantially all of its development activities to the advancement of OP-02 for otitis media. OP-01 may be developed in the future for delivery of drugs into the ear, nose, and sinus cavities.

About Acute Otitis Externa (AOE or “swimmer’s ear)

AOE is a generalized inflammation of the epithelium of the external ear canal that may also involve the pinna and/or the tympanic membrane (eardrum). The vast majority of AOE cases are due to bacterial infections, with Pseudomonas aeruginosa and Staphylococcus aureus being the most common pathogens. The condition is commonly associated with pain and characterized by redness of the ear canal (erythema), swelling of the tissue (edema), increased secretion of fluid, and shedding or peeling of the skin (desquamation of the epithelium). AOE occurs in all age groups and is more frequently observed in the summer months as well as in hot and humid environments. The most common treatment for AOE is antibiotics, with or without steroids, analgesics and avoiding ears being immersed underwater (e.g., swimming). Ear treatments are generally supplied in the form of liquids with several drops administered into each infected ear multiple times per day for a week or longer. In the U.S. alone, more than 5 million prescriptions for ear anti-infective products are prescribed every year, mostly for the treatment of AOE.

The current market leader in the ear anti-infective market is CIPRODEX®, marketed by Alcon, which according to IMS Health generated over $400 million in sales in the United States in 2015. It is a liquid suspension containing the antibiotic ciprofloxacin and the steroid dexamethasone. It is administered as four drops per infected ear, twice-daily over seven days for a total of 14 doses (56 drops placed into the ear canal over the course of a week). There are numerous other branded and generic ear anti-infectives, but none of these are clinically differentiated from CIPRODEX®. Although effective when administered properly, liquid drops like these anti-infectives can be a challenge to administer into the ear, particularly in children. Proper administration requires the patient to lie down with the infected ear pointed upward, careful placement of multiple drops into the infected ear, manipulation of the ear lobe to move the liquid down into the ear canal, and the patient should remain still with the infected ear pointed upwards after applying the product for a period of time to prevent the medication from draining out of the ear. In addition, rapid resolution of otalgia (ear pain) is not achieved with any of the currently approved anti-infective products, even those that also contain an anti-inflammatory (e.g., steroid) in the formulation, like CIPRODEX®.

Forward-looking Statements

Any statements in this website about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, the review of strategic alternatives and the outcome of such review and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, expectations regarding the timing for the commencement and completion of formulation activities or clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability to develop a commercially viable product formulation; the sufficiency of the company’s cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product, any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, it will be successfully distributed and marketed. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.