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Fibromyalgia Therapeutics: Why has progress has been slow?

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. In this post, I share a few thoughts on why advances in the field have been slow and what developments may be coming soon.

Fibromyalgia involves central amplification of peripheral sensory signals, so that otherwise normal sensations are perceived as painful. Most patients afflicted with fibromyalgia also experience excessive tenderness, fatigue, sleep disturbances, problems concentrating, and functional impairment. A major obstacle to diagnosis is the absence of specific laboratory or imaging tests for fibromyalgia, although lab testing can be used to rule out other conditions associated with fatigue. Since the symptoms of fibromyalgia are shared with other conditions, patients should also be evaluated for mood disorders and sleep impairment.

In the decades prior to the introduction of the American College of Rheumatology’s (ACR) classification criteria in 1990, there was considerable skepticism about fibromyalgia as a legitimate medical condition. The 1990 ACR criteria ushered in an era of increased recognition of fibromyalgia and provided a standardized diagnostic approach. This was a boon for academic rheumatologists and even more so for researchers looking to test the efficacy of drugs. Despite widespread dissemination of the diagnostic criteria, skepticism abounded. For example, the very year ACR published the criteria for fibromyalgia, the British Journal of Rheumatology and the Canadian Family Physician journal published papers questioning the existence of fibromyalgia. However, the ACR criteria provided a major boost to research, resulting in the 2006 FDA approval of pregabalin (Lyrica®); the 2008 approval of duloxetine (Cymbalta®); and the 2009 approval of milnacipran (Savella®), which remain the only FDA-approved medicines for the treatment of fibromyalgia.

Although the ACR classification system was a major advance, it proved problematic in a number of ways. First, it required assessment of tenderness on pressure (tender) points in at least 11 of 18 specified sites and the presence of widespread pain for a diagnosis of fibromyalgia. Second, tender point assessment failed to address the symptoms that bothered patients. And finally, digital palpation of 18 tender points was hard for most non-rheumatologists to perform. It became apparent that primary care physicians had neither the time nor the training to perform extensive tender point assessment. Therefore, in 2010, the ACR simplified its criteria, eliminating tender point assessment, and changed the definition of fibromyalgia to an illness characterized by self-reported multiple painful regions and core symptoms such as such as fatigue, sleep disturbances and impaired cognition. In 2011, the ACR provided a self-report version for survey and clinical research purposes, thus spurring further testing of treatments for fibromyalgia. In December 2016, ACR released a further revision to the 2010/2011 criteria to reduce misclassification of regional pain disorders and improve diagnostic clarity. The 2016 modifications provide physician-based criteria for patient diagnosis and self-report criteria for research studies.

Although there are no definitive treatments for fibromyalgia, evidence indicates that lifestyle changes including relaxation, patient education, counseling, and exercise all improve symptoms and should therefore be an active part of any management program. In recent years, several promising drug treatments have failed in clinical trials, although companies such as Astellas, Daiichi Sankyo, Zynerba and SWITCHBIOTECH are pursuing new treatments for fibromyalgia. As awareness is raised and research studies continue, the contributing causes of fibromyalgia will be better understood and allow for the development of superior treatments. Najib Babul, PharmD, MBA



Alzheimer's Disease Year-in-Review 2016

Journey with me through this mini and wholly incomplete Alzheimer's disease 2016 year-in-review.

For the full post on LinkedIn, please see: http://tinyurl.com/hx28m3j


Does the 505(b)(2) Regulatory Pathway for NDA's Provide an Adequate ROI?

I have a post on LinkedIn where I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the “505(b)(2) regulatory pathway”. What are 505(b)(2) new drug applications (NDAs) and do they really provide a meaningful advantage to pharmaceutical companies?

For the full post on LinkedIn, please see: http://tinyurl.com/j9fh2zn

 


ALT Lab Equipment Celebrates Expansion to New Site

Congratulations to ALT Lab Equipment San Diego on their recent expansion to a 14,000 sq ft site at 6444 Nancy Ridge Dr! ALT is a great resource for local biotech startups looking for affordable refurbished lab equipment. Check out this article for more details. Want to see the facility and meet the staff? Join the ALT launch party and ribbon cutting November 30 at 4-6:30 pm.


CureMatch Makes the Xconomy List of San Diego Tech Startups to Watch in 2017


Congratulations to SDEE member, CureMatch, for being named one of Xconomy's 12 San Diego tech startups to follow in 2017! CureMatch Inc. is a startup company founded in 2015 and currently incubating at JLABS San Diego. They have developed a "decision support software platform" to assist physicians in selecting the optimal treatment for cancer patients. The program provides a personalized medicine approach to cancer patient therapeutics. 


Crinetics Pharmaceuticals Appoints Dr. Anne Klibanski to Scientific Advisory Board

Crinetics Pharmaceuticals recently announced the appointment of Dr. Anne Klibanski as a new member of their Scientific Advisory Board. Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.

Scott Struthers, PhD, Founder & CEO of Crinetics commented, “We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company.”

Crinetics Pharmaceuticals Inc. discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of endocrine-related diseases and cancers.


Allele Bio Awarded 2 NIH Grants

Allele Biotechnology and Pharmaceuticals is pleased to announce receiving NIH grants to develop antibody therapies for Alzheimer's Disease and to develop a novel manufacturing system producing stem cells for clinical therapy. 

Allele Biotechnology and Pharmaceuticals, Inc. is a private, San Diego-based company that explores the mechanisms of biological processes to develop technologies and products for biomedical research and therapy development.

Our mission is to increase accessibility to innovative molecular biology research tools by offering cutting edge technologies in individual products and fully integrated platforms. Allele utilizes proprietary non-integrating cellular reprogramming methods to enable drug discovery and cell therapy, including human and non-human primate iPS cells, GMP-grade human iPS cells and their derivatives, and differentiated cell types.  With additional expertise in genome modification and cell-based sensors/reporters, Allele provides advanced cell and assay development solutions. Allele also has developed a wide variety of reagents including superior fluorescent proteins, highly efficient luciferase assay substrates, genotyping kits, and camelid antibodies. The company has also been a leader in the RNAi field with its patents in Pol III promoter-driven siRNA, shRNA, and miRNA.


Neuropore Therapies (NPT) Announces Achievement of $5 Million Milestone with UCB Collaboration

SAN DIEGO, September 13, 2016 -- Neuropore Therapies, Inc. (NPT) announced today that they have successfully achieved a key program milestone in their collaboration with UCB.  After successful completion of a randomized, double-blind, placebo controlled single ascending dose clinical study and additional non-clinical studies, UCB has awarded NPTTM a progression milestone of $5 million. 

 "We are very pleased with UCB’s decision to proceed with the development of this novel therapeutic candidate that initially arose from Neuropore’s drug-discovery platform.  This is an important milestone for Neuropore and reflects UCB’s continued commitment to a promising therapeutic opportunity for the treatment of Parkinson’s disease,” commented Doug Bonhaus, Ph.D., Neuropore’s COO.

For full press release: http://www.businesswire.com/news/home/20160913005482/en/Neuropore-Therapies-NPT-Announces-Achievement-Key-Program


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