Overview
With major advancements in its drug pipeline over the last two years, Synthetic Biologics (SYN) has propelled itself onto the radar of retail investors, philanthropists and major institutions. Only a year ago, Synthetic's average share volume stagnated around 50,000 in what seemed to be a lack of awareness on Wall Street. This year, however, the stock has seen exponential increase in volume and enormous PPS volatility. This is largely centered around the Phase 2 topline readout of the Trimesta/Copaxone study for Multiple Sclerosis (MS). The results were promising in that relapse rates improved up to 47 percent in the first 12 months, but saw a significant drop-off to 32 percent in the second year. This prompted a sharp drop in PPS and a subsequent return to pre-catalyst levels.
These historical events have placed Synthetic on the forefront of reinvigorating treatments for life threatening under-treated diseases, including Pertussis and Clostridium difficile (C. Difficile or C. diff). I will write a followup article on Synthetic's novel anti-infective treatments. For now, however, I will focus on Trimesta, Synthetic's most developed novel treatment. Trimesta has proven efficacy in slowing the symptoms of Multiple Sclerosis. I will examine its potential to compete with Teva Pharmaceutical's (TEVA) Copaxone, Biogen's (BIIB) Tecfidera, and Novartis' (NVS) Gilenya.
What is Trimesta?
Mr. Riley's esteemed approach to developing “sexy drug candidates”(that is, innovative drug candidates that seek to revamp the treatment of infectious and genetic diseases) complements the fact that Synthetic's primary drug candidate, Trimesta, has proven efficacy when implemented in conjunction with Teva's Copaxone drug. Summarizing the clinical findings of Dr. Rhonda Voskuhl, Clinical Director of Synthetic's Trimesta trials, there is no longer a question of whether Trimesta is effective in reducing symptoms of MS in conjunction with Copaxone.
Through extensive trials, Dr. Voskuhl has proven that the drug is capable of restoring estriol in women who may lack optimal levels after taking contraceptives. It also helps that Trimesta has been used for four decades, but simply has never been approved by the FDA. Moreover, Dr. Voskuhl's examination of subjects treated with Trimesta/Copaxone combination demonstrated its effectiveness in slowing the progression of MS symptoms in women, with a calculated 80% reduction of brain lesions. It will be interesting to see how management harnesses this benefit in a future clinical study. Following is what management stated on the subject in Synthetic's Q3 Earnings Report:
Cognition and disability improvement could be a totally new indication for an MS drug. We look forward to updating shareholders on investigators continued analysis as we continue our discussions with potential partners and await the results in the full analysis of the MRI scans due early next year. In the meantime, a separate Phase 2 trial focused exclusively on cognition utilizing Trimesta with a variety of currently marketed MS drugs, including Copaxone, Avonex, Betaseron, Extavia, Rebif, Gilenya, Aubagio and Tecfidera, is enrolling patients at four sites in the United States
In addition, Dr. Voskuhl found that the drugs possess healing components which help regenerate the myelin sheath. For those who are not aware of the significance of this unexpected finding, it is imperative to note that MS is induced by damage to the myelin sheath. Therefore, the capacity of the drugs to regenerate the myelin sheath (a process known as remyelination) is paramount since it may indicate that a potential cure for MS is within reach.
