PRINCETON, NJ, USA I November 22, 2019 I Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, announced the positive top-line results from its Phase 1 “ZEN” study in healthy volunteers. The ZEN Study was an open-label, single-center, randomized, 2-way crossover study to evaluate the relative bioavailability of varenicline administered as a preservative-free nasal spray (OC-01 nasal spray) as compared to varenicline administered orally as a single oral dose of Chantix®.
The ZEN study was designed to assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength (1.2 mg/ml in a 50 microliter nasal spray) compared to varenicline administered as a single oral dose at its commercially available maintenance oral tablet strength (1 mg). The treatment cohort consisted of 22 healthy volunteers who were administered study medication under fasted conditions.
Top-line results indicate that the relative bioavailability (systemic exposure as defined by adjusted geometric mean AUC0-inf) was 13 times lower for a single dose of the highest strength of OC-01 nasal spray as compared to a single dose of the highest strength Chantix® tablet (7.46 vs 99.67 h*ng/ml). Maximal concentration (as defined by adjusted geometric mean Cmax) was 14 times lower for a single dose of the highest strength of OC-01 nasal spray as compared to a single dose of the highest strength Chantix® tablet (0.32 vs 4.55 ng/ml).
The study demonstrated that OC-01 nasal spray was safe and well-tolerated at the doses tested. The number of subjects reporting any treatment-emergent adverse event (TEAE) was 13 out of 21 (61.9 percent) after nasal spray administration and 9 out of 22 (22.9 percent) after oral tablet administration but there were no reports of serious TEAE noted with either oral or nasal administration. The most common adverse events in the nasal spray group were sneeze in 7 volunteers (33.3 percent) and cough in 6 volunteers (28.6 percent). All events were mild. There were no events of sneeze or cough in the oral tablet administration group. The most common adverse events in the oral tablet administration group were nausea in 5 volunteers (22.7 percent) and vomiting in 4 volunteers (18.1 percent). All events were mild or moderate in severity. There were no events of nausea or vomiting in the nasal spray administration group.
“We are pleased by the positive results of the ZEN study as they confirm and validate the pharmacokinetic profile and the fundamental science of our OC-01 nasal spray. OC-01 nasal spray is designed to deliver a concentrated local dose of drug to the nasal mucosa, stimulating the trigeminal nerve to produce natural tear film, while limiting the systemic exposure,” stated Jeffrey Nau, PhD, MMS, Oyster Point’s President and CEO.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray’s novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million Americans and is growing in prevalence. An estimated 16 million U.S. adults have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
SOURCE: Oyster Point Pharma
Post Views: 12
PRINCETON, NJ, USA I November 22, 2019 I Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, announced the positive top-line results from its Phase 1 “ZEN” study in healthy volunteers. The ZEN Study was an open-label, single-center, randomized, 2-way crossover study to evaluate the relative bioavailability of varenicline administered as a preservative-free nasal spray (OC-01 nasal spray) as compared to varenicline administered orally as a single oral dose of Chantix®.
The ZEN study was designed to assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength (1.2 mg/ml in a 50 microliter nasal spray) compared to varenicline administered as a single oral dose at its commercially available maintenance oral tablet strength (1 mg). The treatment cohort consisted of 22 healthy volunteers who were administered study medication under fasted conditions.
Top-line results indicate that the relative bioavailability (systemic exposure as defined by adjusted geometric mean AUC0-inf) was 13 times lower for a single dose of the highest strength of OC-01 nasal spray as compared to a single dose of the highest strength Chantix® tablet (7.46 vs 99.67 h*ng/ml). Maximal concentration (as defined by adjusted geometric mean Cmax) was 14 times lower for a single dose of the highest strength of OC-01 nasal spray as compared to a single dose of the highest strength Chantix® tablet (0.32 vs 4.55 ng/ml).
The study demonstrated that OC-01 nasal spray was safe and well-tolerated at the doses tested. The number of subjects reporting any treatment-emergent adverse event (TEAE) was 13 out of 21 (61.9 percent) after nasal spray administration and 9 out of 22 (22.9 percent) after oral tablet administration but there were no reports of serious TEAE noted with either oral or nasal administration. The most common adverse events in the nasal spray group were sneeze in 7 volunteers (33.3 percent) and cough in 6 volunteers (28.6 percent). All events were mild. There were no events of sneeze or cough in the oral tablet administration group. The most common adverse events in the oral tablet administration group were nausea in 5 volunteers (22.7 percent) and vomiting in 4 volunteers (18.1 percent). All events were mild or moderate in severity. There were no events of nausea or vomiting in the nasal spray administration group.
“We are pleased by the positive results of the ZEN study as they confirm and validate the pharmacokinetic profile and the fundamental science of our OC-01 nasal spray. OC-01 nasal spray is designed to deliver a concentrated local dose of drug to the nasal mucosa, stimulating the trigeminal nerve to produce natural tear film, while limiting the systemic exposure,” stated Jeffrey Nau, PhD, MMS, Oyster Point’s President and CEO.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray’s novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million Americans and is growing in prevalence. An estimated 16 million U.S. adults have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
SOURCE: Oyster Point Pharma
Post Views: 12
