Pherin Pharmaceuticals, Inc.
4962 El Camino Real, Suite 223
Los Altos, CA 94022 USA
PHERIN PHARMACEUTICALS REPORTS FAVORABLE PHASE 3 PILOT/FEASIBILITY CLINICAL STUDY ON NOVEL INTRANASAL MEDICATION FOR ACUTE TREATMENT OF SOCIAL ANXIETY DISORDER AND ISSUANCE OF PATENTS IN THE U.S.A. AND OTHER MAJOR COUNTRIES
Source: Pherin Pharmaceuticals Inc., Los Altos, California,
Date: February 18, 2015
Pherin Pharmaceuticals announced today that it has very recently and successfully completed a Phase 3 pilot/feasibility study for evaluating the safety and efficacy of PH94B-nasal spray for the acute treatment of symptoms in patients with Social Anxiety Disorder (Social Phobia). The study was conducted in the USA. Based on the positive study results, Pherin intends to meet with the US Food & Drug Administration to start the follow-up Phase 3 study of PH94B- nasal spray 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 (SAD) with PH94B and similar allowances in other major countries.
Phase 2 Study Results
A previous Phase 2 clinical trial in 90 SAD patients conducted in three centers to evaluate the effect of PH94B-nasal spray for the acute treatment of symptoms of Social Anxiety Disorder (SAD), as well as its safety and tolerability provided impressive evidence of rapid (10-15 minutes) anxiety reduction for subjects with SAD while role-playing in performance and social engagements in the clinic (American Journal of Psychiatry 2014; 171: 675-682). In this and earlier studies PH94B-nasal spray was found to have a very favorable safety profile. In discussions with CDER during the FDA End of Phase 2 Meeting Pherin Pharmaceuticals was encouraged to enter Phase 3 clinical trials using the same patient rated Subjective Units of Distress Scale as primary outcome measure to evaluate the feasibility of using the study medication on an “as needed” basis for anxiety provoking performance and social events in daily life situations. A general plan for a cross-over study in which subjects would use PH94B-nasal spray or placebo-nasal spray on a PRN basis and record their anxiety levels during stressful events through diary entries was proposed. In addition, FDA encouraged Pherin Pharmaceuticals to include evaluation of gender and other effects in subsequent studies.
Phase 3 Pilot/Feasibility Study Results
This was a randomized, double blind, crossover pilot/feasibility Phase 3 study in 22 SAD patients. PH94B-nasal spray (1600 nanograms for women, and 3200 nanograms for men) was evaluated against placebo. The results of this study support the new treatment approach. The cross-over design, use of SUDS as primary endpoint, diary recording of responses, inclusion of both genders, and feasibility of using PH94B-nasal spray on a PRN basis were all supported by the results of this pilot study as a model for the follow-up Phase 3 clinical studies.
PH94B significantly improved the primary efficacy endpoint within 10-15 minutes of administration. Secondary efficacy endpoints for the trial included additional physician and patient (self) anxiety response assessments (LSAS, CGI and PGI) and other symptom assessments at various time points of the four-week crossover treatment. Safety evaluations were made throughout the clinical trial period. PH94B showed clinically significant efficacy to reduce Social Anxiety Disorder symptoms as compared to the effect of placebo, and the PH94B symptom improvement exceeded significantly the effect of treatment with placebo during daily life challenges (t= 3.09; p< .006).
“These results are impressive, and position PH94B-nasal spray as a first in class indication for acute treatment of Social Anxiety Disorder due to the demonstrated rapid onset of efficacy, easy route of administration, PRN dosing convenience and excellent safety profile against other existing therapeutic options which require chronic dosing and have concurrent side effects” said Dr. Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. “We are enthusiastic about sharing data with interested companies to co-develop PH94B-nasal spray. If the magnitude of benefits shown in our previous Phase 2 trials and in this pilot/feasibility Phase 3 study is confirmed in the larger-scale follow-up Phase 3 trials, PH94B-nasal spray 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-nasal spray administration and the medication was well tolerated. Pherin attributes these results to the unique formulation of PH94B.
Pherin also reports that in 2014 the US Patent & Trademark Office issued a Notice of Allowance for Pherin’s patent application covering the acute treatment of Social Phobia with PH94B. Corresponding applications in Australia, Canada, China, Denmark, France, Germany, Great Britain, Ireland, Italy, Japan, Mexico, Netherlands, South Korea, Spain, Sweden and Switzerland have already issued as patent; while corresponding 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 Pherin proprietary compounds called pherines. With intranasal spray administration, it acts locally on peripheral nasal chemosensory receptors that trigger rapid activation of the hypothalamic-limbic areas of the brain associated with Social Anxiety Disorder. This mechanism of pharmacological action, the rapid onset of efficacy, and the excellent safety and tolerability profile shown in clinical trials make PH94B an excellent product candidate for the acute treatment of patients with Social Anxiety.
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 effect (several weeks) and known side effects that may make them unattractive to sufferers from Social Phobia.
There are no other medications to Pherin’s knowledge approved by FDA and being marketed for acute treatment of Social Anxiety Disorder. The current anecdotal acute treatment used for discrete Social Anxiety Disorder is propranolol, which to Pherin’s knowledge, is taken 30-60 minutes before the expected time of the performance situation, is associated with its own side effects, has never been studied for SAD in FDA approved placebo controlled trials, and it is limited in treatment of the generalized form of SAD.
About Pherin Pharmaceuticals
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 chemosensory receptors in the nasal passages that affect the hypothalamus and the limbic system and induce proven behavioral and neuropsychiatric effects in humans. Among Pherin’s extensive library of pherines there are molecules being studied for their potential acute therapeutic application including treatment of depression, menopausal hot flashes, premenstrual disorders and improving cognition.
Pherin Pharmaceuticals is the leader in the development of pherines, having pioneered breakthrough discoveries of the behavioral and psychological effects of a large number of pherines that can be administered airborne to the nasal passages in nanogram or low microgram doses. Pherin’s mission is to improve people’s quality of life by pioneering novel healthcare products that make distinct improvements over other treatments.
This press release contains certain forward-looking statements relating to Pherin Pharmaceuticals 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 Pharmaceuticals 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.
Dr. Louis Monti
Pherin Pharmaceuticals, Inc.