September 30, 2016 2:48 AM ET

Pharmaceuticals

Company Overview of NovaDigm Therapeutics, Inc.

Company Overview

NovaDigm Therapeutics, Inc. develops immunotherapeutics and preventative vaccines to protect patients from fungal and bacterial diseases. It offers NDV-3A, a vaccine to demonstrate preclinical efficacy in reducing the severity of disease caused by fungal and bacterial pathogens. NovaDigm Therapeutics, Inc. was founded in 2005 and is based in Brookline, Massachusetts.

1622A Beacon Street

Suite 302

Brookline, MA 02446

United States

Founded in 2005

Phone:

701-757-5161

Fax:

701-335-7121

Key Executives for NovaDigm Therapeutics, Inc.

Chief Executive Officer and Director
Chief Business Officer and Director
Scientific Founder
Scientific Founder
Scientific Founder
Compensation as of Fiscal Year 2016.

NovaDigm Therapeutics, Inc. Key Developments

NovaDigm Therapeutics Announces Positive Results from Antifungal Immunotherapy in Phase 2a Study in Women with Recurrent Vulvovaginal Candidiasis

NovaDigm Therapeutics announced positive data from the Company’s Phase 2a clinical trial evaluating its NDV-3A immunotherapeutic vaccine in women with recurrent vulvovaginal candidiasis (RVVC). The study of 188 patients at 20 clinical sites met its primary endpoint of safety and tolerability. There were no significant differences between NDV-3A and placebo for injection site reactions and systemic reactions of grade 3 or greater. A single dose of NDV-3A generated very rapid and robust immune responses. Exploratory efficacy measures based on patient-reported symptom scores showed a trend toward significance at the 12-month follow-up period (p=0.10). Younger patients showed higher efficacy rates. In patients under 40 years of age (80% of the study population), NDV-3A recipients were about 50% more likely to be recurrence free at the end of the study compared to placebo recipients (p<0.05). Full results of the study will be published at a later date. Nine million women in the United States (11%) report having recurrent yeast infections, with approximately seven million (9%) experiencing RVVC, which has been defined as having three or more episodes per year. Approximately 90% of patients report onset of RVVC prior to the age of 40 years. Many of these women experience frequent episodes of pain and discomfort, high rates of depression and a reduced overall quality of life. While current therapies are effective at controlling acute infections, they do not control recurrences without chronic antifungal suppression, which is not widely used due to potential adverse events. The Phase 2a trial was a multi-center, double-blind, randomized, placebo-controlled study evaluating the safety, tolerability, immunogenicity and efficacy of NDV-3A. The study enrolled 188 patients over 20 US study sites. Patients were assigned one dose of either 300µg NDV-3A immunotherapy or a placebo. The primary objective of the study was to assess the safety and tolerability of a single, intramuscular dose of NDV-3A, as compared to placebo, in patients with at least three episodes of VVC in the past 12 months. Secondary objectives included assessments of humoral and cellular immune responses and various measures of efficacy in reducing the frequency and/or severity of recurrences over a 12-month period.

NovaDigm Therapeutics, Inc. Presents at BIO International Convention 2015, Jun-18-2015 01:00 PM

NovaDigm Therapeutics, Inc. Presents at BIO International Convention 2015, Jun-18-2015 01:00 PM. Venue: Pennsylvania Convention Center, Philadelphia, Pennsylvania, United States. Speakers: Timothy Cooke, Chief Executive Officer and Director.

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