The article yesterday had some interesting items.
Post# of 148179
Interesting take aways, especially the Nash talk, remember this guy was ceo of galt.
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The perception amongst most people is that it's really easy to take a daily regimen of pills, but this perception is not grounded in fact. According to the New England Journal of Medicine adherence drops the more frequent the daily dosing. A pill taken 4 times daily only has a 31-71% adherence rate. The top reason for poor adherence was forgetfulness (30%) and other priorities (16%). Encapsulate this finding into the category of just being human. For chronic diseases, studies have shown that only 40% are compliant. HIV is a chronic disease and so is diabetes, so inferences can be made about future compliance of a once a week injectable. A diabetes study showed a patient compliance rate of 79% in a weekly self-injectable versus 38% in a daily injectable. It doesn't take much of a leap to imagine this very convenient patient compliance-friendly therapy could take on the $25 billion a year HIV market.
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Cure - The only patient showing evidence of a cure, Timothy Brown, received a bone marrow transplant from a CCR5 Delta 32 patient. Reportedly, this could be duplicated only with leronlimab use. The highly anticipated animal study data will be published in peer review by the end of 2019.
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They completed one of three parts and are expected to submit the final two parts in September. Investors would have been informed by now if the first part was rejected .
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The likely suitors would be the top players in HIV like Gilead (GILD) with its Biktarvy, GlaxoSmithKline (NYSE:GSK) with Tivicay and Tiumeq, and Janssen a subsidiary of Johnson & Johnson (JNJ) with Juluca. GILD still has a dominant position in HIV and has been accused of anti-competitive practices. As the front runner, GILD is a target with their one pill a day regimen versus Viiv with their a once a month intramuscular injectable that has side effects of nausea, lack of energy, and even kidney failure. GILD and GSX are trying to change the paradigm in HIV by having the doses last longer, but only CYDY's PRO 140 with their incredible safety profile is likely to have any sustainability.
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CYDY's entry into NASH could really shake up the industry because the other companies would be competing against a non-toxic drug likely to be approved in a different indication.
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Any efficacy in NASH would make CYDY a must-have. The irony of it all is that there is a one-year study where a CCR2/CCR5 agonist was used in NASH and showed remarkable results in a subset of patients that showed a statistically significant benefit in the fibrosis reduction endpoint. This study eventually led Allergan to buy Tobira for $1.7 billion. Although Cenicriviroc missed the primary endpoint, the target CCR5 was validated. Now, CYDY is going after the same CCR5 target with a non-toxic drug. With a $150 million market cap, the market is clearly discounting this outcome. Investors would be well served to read Dr. Kenneth Sherman's journal article on Fatty Liver Disease in Persons with HIV Infection. In this article, they will learn that "CCR5 is now a pharmacologic target." This means that the CCR5 expression on hepatic stellate cells (HSC) promotes scar tissue formation and increases the rate of fibrosis in patients with HIV.
Article
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6550355/
Fatty Liver Disease in Persons With HIV Infection