In The Spotlight: Novus Therapeutics

(RTTNews) - Shares of Novus Therapeutics (NVUS) are up an impressive 47% so far this month while the iShares Nasdaq Biotechnology Index (ETF)(IBB) is up a mere 3% for the same period.

Novus is a development stage specialty pharmaceutical company focused on developing products for disorders of the ear, nose, and throat.

The lead product is OP-02, a drug-device product being developed as a first-in-class treatment option for otitis media, which has a global incidence of over 700 million cases every year.

Otitis media (OM) is an umbrella term that refers to a group of inflammatory diseases of the middle ear like Acute otitis media or "AOM" (inflammation with infectious fluid); Otitis media with effusion or "OME" (inflammation with non-infectious fluid) and Chronic suppurative otitis media or "CSOM" (eardrum perforation with persistent drainage).

The global market for Acute Otitis Media treatment, which was valued at $2.04 billion in 2016, is projected to exceed $3.2 billion by 2025, according to recent report by Coherent Market Insights.

Although Acute Otitis Media can resolve on its own, antibiotics and surgery are the treatment options for it.

Novus' OP-02 has successfully completed pre-clinical studies, and the Company is planning to initiate its first-in-human clinical studies with OP-02 in healthy adults in the second half of 2018.

A phase I study of OP-02 in children with otitis media with effusion, and a phase I study in adults with acute otitis media are expected to be initiated in the first half of 2019. Top line data from the phase I studies are expected in the first half of 2019.

Also in the pipeline is OP-01, a foam treatment for Acute Otitis Externa, or "swimmer's ear".

Acute Otitis Externa is a common condition of the external ear canal involving inflammation and infection. The current market leader in the ear anti-infective market is CIPRODEX, marketed by Alcon.

The Company had tested the first generation formulation of OP-O1 in a phase II trial, and the safety and efficacy data announced in January 2015, demonstrated that OP-O1 is similar (non-inferior) to CIPRODEX.

*Key Numbers...

Accumulated deficit: $30.3 million

Cash: $22.5 million

(*As of Mar.31, 2018)

NVUS touched a yearly high of $6.97 on May 21, 2018. The stock closed yesterday's trading at $6.66, down 4% from its 52-week high.