Berg to Present Clinical Data at ESMO 2017

Berg Health Press Release

Berg to Present Clinical Data at ESMO 2017 That Demonstrates Benefits of BPM 31510 for Pancreatic Cancer Patients and BPM 31543 for Those Suffering from Chemotherapy-Induced Alopecia (CIA)

New Data Shows Encouraging Results That Will Advance Clinical Study, Provide New Treatment Options for Under-served Cancer Patients

FRAMINGHAM, Mass., September 7 – Berg, a biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced two poster presentations showing promising clinical data that will be unveiled at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, from September 8-12.

The first presentation is a Phase II study of leading product candidate, BPM 31510, which was used as a monotherapy and in combination with gemcitabine to evaluate response rates for patients suffering from advanced pancreatic cancer. 

The second presentation is a Phase I dose-escalation safety study of topical calcitriol BPM 31543 for the prevention of Chemotherapy-Induced Alopecia (CIA).

The research was guided by Berg’s Interrogative Biology® platform, which places the patient at the center of research and development by integrating molecular, clinical and demographic information to map the patient’s disease state.

The presentations will both be on display on Sunday, September 10, from 1:15-2:15 p.m. CEST / 7:15-8:15 a.m. EST.

• Title: Phase II Clinical Investigation of BPM 31510 (Ubidecarenone) Alone and in Combination with Gemcitabine in Patients with Advanced Pancreatic Cancer. (Abstract 170509): 

Berg will present data from the Phase II study of BPM 31510 (IV) in advanced pancreatic cancer alone (monotherapy) and in combination with gemcitabine to evaluate overall survival rates. Preclinical in vivo pancreatic models demonstrate that BPM 31510 alone and in combination with gemcitabine significantly improves the duration of survival, which provided support for the Phase II evaluation of BPM 31510. The data presented at ESMO from the Phase II study shows that BPM 31510 is well tolerated by patients and demonstrates signs of efficacy.

• Title: A Phase I Safety Study of Topical Calcitriol (BPM 31543) for the Prevention of Chemotherapy-Induced Alopecia (CIA) (Abstract 17509)

Berg will also release data from its Phase I trial for its topical calcitriol, BPM 31543, for the prevention of Chemotherapy-Induced Alopecia (CIA). Many cancer patients who are treated by chemotherapy encounter hair loss or Alopecia as a major side effect, which can lead to significant psychosocial and quality-of-life issues. There are few treatments for CIA other than FDA-approved cooling caps that can be expensive, uncomfortable and only administered at a clinic. BERG’s topical BPM 31543 can be taken at home, which could offer significant ease-of-use benefits to the patient. The data presented at ESMO from the Phase I safety study shows that the topical compound is safe and well tolerated by patients with initial signs of efficacy.

“The findings that BERG is presenting at ESMO have the potential to help cancer patients in a number of ways, primarily by taking an innovative approach to treating highly metabolic tumors, like pancreatic cancer, and carving out a path to developing the first chemical therapeutic for the prevention of Chemotherapy-Induced Alopecia,” says Niven R. Narain, Berg Co-Founder, President and Chief Executive Officer. “We’re very encouraged by the results for both BPM 31510 and BPM 31543, and look forward to advancing these studies in the clinic and helping under-served cancer patients.”

At ESMO (Booth #239), Berg will be demonstrating the capabilities of the company’s Interrogative Biology® platform. Its unbiased, algorithm-based approach guides the discovery, development and clinical evaluation of product candidates to create the next generation of drugs and diagnostics. BPM 31510 is one of the first cancer drug candidates guided in development by artificial intelligence.

About Berg 
Berg is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. Its platform identifies therapies and biomarkers by applying algorithm- and probability-based artificial intelligence to analyze large numbers of patients’ genotypic, phenotypic and other characteristics. Berg’s platform operates at the intersection of biology, technology and artificial intelligence analytics and integrates many data characteristics regarding patients’ lifestyles, demographics and biology. BERG believes this allows the company to better understand patients’ disease profiles and consequently to identify and reveal molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, Berg is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. Berg has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology.

For additional information, please visit www.BERGhealth.com.