Welcome!

News Feed Item

Pherin Pharmaceuticals Reports Favorable Clinical, Regulatory, and Intellectual Property Actions on Novel Intranasal Medication for Acute Treatment of Social Anxiety Disorder and Issuance of Patents in the U.S.A. and Other Major Countries

LOS ALTOS, CA -- (Marketwire) -- 12/05/12 -- Pherin Pharmaceuticals announced today that a Phase II clinical trial showed that its proprietary compound PH94B demonstrated significant benefits in the acute treatment of symptoms of Social Anxiety Disorder (Social Phobia). Based on the positive study results, Pherin has met with the US Food & Drug Administration to plan a Phase III pivotal study of PH94B for the acute treatment of Social Anxiety Disorder. Also, Pherin has received Notification of Issuance from the US Patent & Trademark Office for its patent application covering the acute treatment of Social Anxiety Disorder with PH94B and similar allowances in the European Union, Japan, China and other major countries.

Phase II Study Results
The Phase II study was conducted in three centers to evaluate the effect of PH94B for the acute treatment of symptoms of Social Anxiety Disorder, as well as its safety and tolerability. It was a randomized, double blind, single-administration, placebo-controlled study in 91 Social Anxiety Disorder patients, using validated psychometric scales. PH94B (800 nanograms) was evaluated against placebo. PH94B significantly improved the primary efficacy endpoints (social performance and social interaction anxiety) within 10 minutes of administration. Secondary efficacy endpoints for the trial included additional anxiety response assessments and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period. PH94B showed clinical efficacy to reduce Social Anxiety Disorder symptoms in 75.6% patients as compared with placebo (37% only). The PH94B treated group improvement exceeded the placebo treated group during a Public Speaking challenge (t = 3.16; p < .01) and also during a Social Interaction challenge (t = 2.67; p < .01).

"These results are impressive and position PH94B favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require chronic dosing and have concurrent side effects," said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. "We are enthusiastic about sharing data with interested companies to co-develop PH94B. If the magnitude of benefits shown in this Phase IIB study is confirmed in a larger-scale Phase III study, intranasal PH94B could represent a major improvement in the way Social Anxiety Disorder will be treated in the future."

There were no adverse events associated with PH94B and the medication was well tolerated. Pherin attributes these results to the unique formulation of PH94B.

Regulatory Interaction
Pherin Pharmaceuticals also reports that it held a successful End-of-Phase II meeting with the U.S. Food and Drug Administration regarding PH94B. Pherin is in the process of submitting the safety reports of four favorable studies and an updated version of the Phase 3 clinical protocol in order to enable Pherin to move into Phase 3 clinical trials in the very near term.

Intellectual Property
Pherin also reports that the US Patent & Trademark Office has issued a Notice of Allowance for Pherin's patent application covering the acute treatment of Social Phobia with PH94B. A corresponding application in Mexico and Australia have already issued as patent; while corresponding applications in China, Japan and the European Patent Office have been allowed; and applications remain pending in several other countries. Pherin expects these applications and patents to provide broad intellectual property protection for the use of PH94B in the acute treatment of Social Anxiety Disorder.

About PH94B and Social Anxiety Disorder
PH94B is one of a new class of Pherin proprietary compounds called pherines. With intranasal spray administration, it acts locally on peripheral receptors from nasal chemosensory neurons that connect to the hypothalamic-limbic areas of the brain. This mechanism of pharmacological action, the rapid onset of effect, and the excellent safety and tolerability profile make PH94B an excellent product candidate for the acute treatment of patients with Social Anxiety Disorder.

Social Anxiety Disorder, also called Social Phobia, is reportedly the most common anxiety disorder, with a lifetime prevalence of 13-14%. Social Anxiety Disorder is characterized by a persistent and unreasonable fear of one or more social or performance situations, where the individual fears that he or she will act in a way or show symptoms that will be embarrassing or humiliating, leading to avoidance of the situations when possible and anxiety or distress when they occur. There are two types: generalized Social Anxiety Disorder, where the fears are related to both social and performance situations; and discrete Social Anxiety Disorder, where the fears are related to particular performance anxiety situations only, such as public speaking. These fears can have a significant impact on the person's employment, social activities and overall quality of life. Social Anxiety Disorder is commonly treated chronically with antidepressants, which have a slow onset of action and side effects that may make them unattractive to sufferers from Social Phobia. There are no acute treatments for generalized Social Anxiety Disorder; and the current acute treatments for discrete Social Anxiety Disorder are beta-blockers, which must be taken 30-60 minutes before the expected time of the performance situation and are associated with their own side effects.

About Pherin
Pherin Pharmaceuticals, Inc. of Los Altos, California, is a clinical stage drug development company that has developed a family of leading and innovative proprietary compounds called pherines that bind to peripheral receptors in the nasal passages that affect the hypothalamus and the limbic system and induce proven behavioral, neuropsychiatric and neuroendocrine effects in humans. Among Pherin's extensive library of pherines there are molecules being studied for their potential therapeutic application including treatment of depression, premenstrual dysphoric disorder and cognition enhancement.

Pherin is the leader in the development of pherines, having pioneered breakthrough discoveries of the behavioral and neuroendocrine effects of a large number of pherines that can be administered airborne to the nasal passages in nanogram or low microgram range. Pherin's mission is to improve people's lives by pioneering novel healthcare products that make distinct improvements over other treatments.

Disclaimer
This press release contains certain forward-looking statements relating to Pherin and the future development of PH94B, its safety and effectiveness in treating Social Phobia, and its patent position. Such forward-looking statements reflect the current views of Pherin regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with PH94B to be materially different from any future results, performance or achievements expressed or implied by such statements.

CONTACT:

Dr. Louis Monti
Pherin Pharmaceuticals, Inc.
(650) 961-2080
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
With more than 30 Kubernetes solutions in the marketplace, it's tempting to think Kubernetes and the vendor ecosystem has solved the problem of operationalizing containers at scale or of automatically managing the elasticity of the underlying infrastructure that these solutions need to be truly scalable. Far from it. There are at least six major pain points that companies experience when they try to deploy and run Kubernetes in their complex environments. In this presentation, the speaker will d...
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations might...
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
When building large, cloud-based applications that operate at a high scale, it's important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. "Fly two mistakes high" is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Le...
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
As Cybric's Chief Technology Officer, Mike D. Kail is responsible for the strategic vision and technical direction of the platform. Prior to founding Cybric, Mike was Yahoo's CIO and SVP of Infrastructure, where he led the IT and Data Center functions for the company. He has more than 24 years of IT Operations experience with a focus on highly-scalable architectures.
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
CI/CD is conceptually straightforward, yet often technically intricate to implement since it requires time and opportunities to develop intimate understanding on not only DevOps processes and operations, but likely product integrations with multiple platforms. This session intends to bridge the gap by offering an intense learning experience while witnessing the processes and operations to build from zero to a simple, yet functional CI/CD pipeline integrated with Jenkins, Github, Docker and Azure...
René Bostic is the Technical VP of the IBM Cloud Unit in North America. Enjoying her career with IBM during the modern millennial technological era, she is an expert in cloud computing, DevOps and emerging cloud technologies such as Blockchain. Her strengths and core competencies include a proven record of accomplishments in consensus building at all levels to assess, plan, and implement enterprise and cloud computing solutions. René is a member of the Society of Women Engineers (SWE) and a m...
Dhiraj Sehgal works in Delphix's product and solution organization. His focus has been DevOps, DataOps, private cloud and datacenters customers, technologies and products. He has wealth of experience in cloud focused and virtualized technologies ranging from compute, networking to storage. He has spoken at Cloud Expo for last 3 years now in New York and Santa Clara.
Enterprises are striving to become digital businesses for differentiated innovation and customer-centricity. Traditionally, they focused on digitizing processes and paper workflow. To be a disruptor and compete against new players, they need to gain insight into business data and innovate at scale. Cloud and cognitive technologies can help them leverage hidden data in SAP/ERP systems to fuel their businesses to accelerate digital transformation success.
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.