The pharmacodynamics phase 1 clinical trial began in February and is expected to be completed sometime in March.
Novus Therapeutics (NASDAQ:NVUS) has officially dosed the first patient in its phase 1 pharmacodynamics clinical trial to treat otitis media, which are inflammatory diseases of the middle ear, the company said on Monday (February 11).
The study, called OP0201-C-001, is evaluating the company’s lead product candidate OP0201 for safety, tolerability and Eustachian tube (ET) function after one intranasal dose of the drug, when compared to a placebo, in 16 healthy adult patients.
Pharmacodynamics studies tests the effects of drugs on healthy volunteers or patients. According to ClinicalTrials.gov, the study period began in February in Germany and is expected to be completed sometime next month.
“This study aims to explore the potential effect of OP0201 on Eustachian tube function as subjects are exposed to changes in atmospheric pressure,” Dr. Catherine Turkel, president of Novus, said in the release. Turkel added that results from the study will become available sometime later in the year.
ClinicalTrials says that the primary outcome of the study is safety while the secondary is the evaluation of the ET function using continuous tympanic impedance measure. OP0201 will be given as a 20 mg one time dose followed by a washout and a single dose of the opposite intervention. Meanwhile, the placebo will be dosed 0 mg, also followed by a washout and single dose of the opposite intervention.
OP0201 is the combination of a drug device product that is made up of a proprietary formulation of a surfactant and a spreading agent suspended in propellant. The product is taken intranasally through a pressurized metered-dose inhaler and is meant to restore normal ET functions.
While this is the company’s only pharmacodynamics study for the drug, Novus has a number of other phase 1 clinical studies for OPO201 under way. Case in point, in November Novus dosed the first adult patients in a low cohort of a phase 1 clinical trial for the candidate. Thanks to the initiation of this phase 1 study, the company said it hopes to eventually evaluate OPO201 in children who have otitis media.
By January, Novus had dosed the first adult patient with acute otitis media in a phase 1 clinical trial of the candidate. This study aims to test safety and ear pain relief following one intranasal dose of OPO201 throughout a 60-minute observation period in 24 patients with the condition.
Otitis media is a bacterial infection of the middle ear. These infections usually happen at the same time as colds, allergies, nose and throat infections. The main types of otitis media include acute, otitis media with effusion, and chronic otitis media with effusion. John Hopkins Medicine describes symptoms as being irritability, troubles sleeping, pulling ears, fever and fluid draining from the ears.
Overall, treatment options for ear infections such as acute otitis externa, otitis media with effusion and acute otitis media, are expected to grow at a compound annual growth rate of 5 percent between 2019 and 2023, according to a Technavio report. With treatment options potentially increasing for these infections, Novus Therapeutics will certainly be on investors’ radars as these clinical trials evolve.
However, shares of the company didn’t react favorably as of market close on Monday. Over the one-day trading period, Novus’ stock price took a 4.71 percent dip to close the session at US$4.45. Year-to-date, shares of Novus are up 168 percent from $US1.66 on January 2.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.