Full Press Release Details
Pharmaceuticals, Inc.
Pharmaceuticals Phase 2 Trial Update
Silverman - Chairman, MyMD Pharmaceuticals, Inc.
Chapman - President, Director, and Chief Medical Officer, MyMD Pharmaceuticals, Inc.
Kaplin - Chief Scientific Officer, MyMD Pharmaceuticals, Inc.
day everyone, and welcome to the MyMD Phase 2 data call. At this time, all participants have been placed on a listen-only mode. [Operator
is now my pleasure to turn the floor over to your host, Josh Silverman, Chairman of MyMD Pharmaceuticals. Sir, the floor is yours.
Silverman - Chairman, MyMD Pharmaceuticals, Inc.
afternoon, and thank you for joining this MyMD Pharmaceuticals Investor Conference Call to discuss our recently released Phase 2 trial
results for our next generation oral TNF- inhibitor, MYMD-1. My name is Josh Silverman, Chairman of MyMD Pharmaceuticals. Before
we begin, I'd like to call your attention to the safe harbor disclosure regarding forward-looking information.
conference call today will contain certain forward-looking statements, including statements regarding the goals, strategic beliefs, expectations,
and future potential results of MyMD Pharmaceuticals, Inc. Although management believes these statements are reasonable based on estimates,
assumptions and projections, as of today, August 2, 2023, these statements are not guarantee of future performance. Actual results may
differ materially as a result of risks, uncertainties and other factors, including, but not limited to the factors set forth in the company's
filings with the SEC.
undertakes no obligation to update or revise any of these forward-looking statements. As a reminder, MyMD is a clinical stage pharmaceutical
company committed to developing novel immunotherapies with a focus on inflammation and age related diseases. We are excited to discuss
our Phase 2 results today, which mark a milestone in our progress towards increasing lifespan and improving lives. Joining myself on
the call today are Dr. Chris Chapman, President, Director, and Chief Medical Officer at MyMD as well as Dr. Adam Kaplin, Chief Scientific
Officer at MyMD and Adjunct Faculty at Johns Hopkins University of Medicine.
now like to turn it over to Dr. Chapman for his initial remarks.
Chapman - President, Director, and Chief Medical Officer, MyMD Pharmaceuticals, Inc.
you, Mr. Silverman. This is a big week for MyMD, a scientific leader and cutting edge developer at the forefront of innovation. Our flagship
product is the next generation TNF- inhibitor, uniquely designed for oral administration and brain accessibility, with selected
properties that offer a compelling promise of enhanced safety and efficacy.
is a differentiator from current TNF- injectable medication, which because of their potential for substantial immunosuppression
carries significant Black Box warnings regarding the risk of severe infections. The global market for TNF- inhibitors currently
stands at an impressive $40 billion, with Humira leading the pack at $20 billion, solidifying its position as the world's top selling
drug. With MYMD-1 in our arsenal, we have an extraordinary opportunity to make a substantial impact on the pharmaceutical landscape,
with the potential for success in a significant market.
we're excited to share today our positive, statistically significant top line results from our randomized Phase 2 study in patients
with chronic inflammation associated with sarcopenia or age related frailty.
diving deeper into the results, I'd like to introduce Dr. Adam Kaplin, our Chief Scientific Officer, who will discuss the remarkable
properties of MYMD-1 and explore the reasons behind our belief and its ability to address a spectrum of diseases through its unique mechanism
of action. Dr. Kaplin?
Kaplin - Chief Scientific Officer, MyMD Pharmaceuticals, Inc.
you very much, Dr. Chapman. At its core, MYMD-1 serves as an immune system regulator designed for the oral administration to precisely
modulate the release of inflammatory cytokines, including the critical proinflammatory cytokine, TNF- . Cytokines, acting as chemical
messengers within the immune system orchestrate communication and coordination among cells. TNF- in particular holds a crucial
role as a primary cytokine regulator responsible for inducing inflammation.
its persistent overactivity triggers a cycle of immune dysregulation, leading to the onset and perpetuation of chronic inflammation and
autoimmune disease. The resulting inflammation can arise as a defensive response to foreign invaders or be the product of an underlying
illness that has taken hold.
age related diseases are often accompanied by immune system overactivation, consequently leading to increased inflammation. Conditions
such as heart, lung and kidney disease, and cancer, Alzheimer's disease and various autoimmune diseases share a commonality, which
is the cascade of cytokine activation leading to uncontrollable inflammation, with TNF- acting as the igniting spark and fuel
to perpetuate the underlying disease.
is distinguishable from the currently available TNF- inhibitors in that it targets the root cause of immune activation and inflammation
beyond merely addressing the symptoms. Our research has demonstrated that MYMD-1 selectively targets and suppresses TNF- elevations
associated with autoimmune diseases but does not prevent elevations associated with fighting off infections.
currently available TNF- inhibitors are nonselective and can inhibit TNF- both in autoimmune diseases and in the course
of fighting off infections, all such drugs carry a Black Box warning for serious infections requiring hospitalization or death. Based
on these findings of selectivity we anticipate MYMD-1 will have a much safer side effect profile than the currently available TNF-
unlike all currently available TNF- inhibitors, MYMD-1 is brain permeable, making it capable of inhibiting TNF- in the
central nervous system, offering the potential application in treating a range of CNS conditions associated with inflammation such as
depression, multiple sclerosis, Alzheimer's and Parkinson's disease, and many others. Although noticeable differences with
the currently available TNF- inhibitors is that MYMD-1 is a triple threat to chronic inflammation and autoimmune disease, blocking
not only TNF- but also IL-6 and IL-17.
are separate biologics that target each of these three cytokines, TNF- , which for example is indicated to treat inflammatory bowel
disease and rheumatoid arthritis, IL-17, which is approved to treat psoriasis and IL-6 biologics approved to treat arthritis.
to the best of our knowledge, none of them can tackle extinguishing the inflammation mediated by all three at once. Two notable instances
of immune system over activation, where TNF- plays a pivotal role are one, autoimmune diseases like multiple sclerosis, rheumatoid
arthritis and inflammatory bowel disease, where the body mistakenly attacks itself and two, cytokine storms observed in conditions like
COVID-19 where the immune system launches an overwhelming assault.
TNF- selectively is considered a key to preventing the uncontrolled damage while preserving the ability to combat infections,
a precise capability that MYMD-1 is designed to provide. MYMD-1 has already demonstrated in lab studies potent abilities to inhibit both
autoimmune diseases as well as cytokine storms.
will now turn the call back to Dr. Chapman, who will discuss our exciting Phase 2 trial results in more detail.
Chapman - President, Director, and Chief Medical Officer, MyMD Pharmaceuticals, Inc.
you again, Dr. Kaplin. Today is a significant milestone for MyMD as we announced statistically significant positive, top line Phase 2
results for MYMD-1 in patients with chronic inflammation associated with sarcopenia, a component of age related frailty. The Phase 2
multicenter, double-blind, placebo controlled randomized study was designed to investigate the efficacy, tolerability and pharmacokinetics
of MYMD-1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia, frailty, a condition linked to
chronic inflammation and elevated levels of proinflammatory cytokines. Patients in the study were dosed daily with MYMD-1 or a placebo
over a 28 day period.
study consisted of four cohorts consisting of 10 subjects, eight drugs and two placebo, cohort 1, 600 milligrams, cohort 2, 750 milligrams,
cohort 3, 900 milligrams and cohort 4, 1050 milligrams. Our study met both of its primary endpoints significantly reduced in serum levels
of three biomarkers. TNF- P was equal to 0.008, starting with TNF- receptor 1, P was equal to 0.02, and Interleukin-6,
maintaining appropriate plasma concentrations and parameters of pharmacokinetic evaluations. The study also achieved all secondary endpoints
related to safety and tolerability. There were no treatment related adverse events or serious adverse events over the course of the study.
has the potential to be the first drug approved by the FDA for sarcopenia which is a key mediator of age related decline in physical
function, which leads to greater risk of hospitalization, disability, and death. Sarcopenia is a condition characterized by a progressive
loss of muscle strength and function in older adults. In addition to being common in the elderly, where the result of chronic inflammation,
sarcopenia can be associated with people who have diabetes or obese, perform little or no exercise, have poor nutrition or smoke.
going to turn over to Dr. Kaplin, who would share with a few statistics on how impactful sarcopenia across the U.S. population is.
Kaplin - Chief Scientific Officer, MyMD Pharmaceuticals, Inc.
were nearly 56 million people aged 65 or older in 2020, with one in six people in the U.S. now aged 65 or older, a demographic projected
to continue growing until at least 2030. Estimated cost of hospitalizations in the United States in individuals with sarcopenia was estimated
at $40.4 billion. On average, it is estimated that 5% to 13% of elderly people between the ages of 60 and 70 are affected by sarcopenia.
These numbers increase dramatically to 11% to 50% of those aged 80 or above, representing up to six million people afflicted with sarcopenia
in this age range alone.
are the populations we hope to address and help. And again, there are no FDA approved treatments for chronic inflammation associated
with sarcopenia or frailty for those aged 65 years or older today.
will let Dr. Chapman conclude the presentation.
Chapman - President, Director, and Chief Medical Officer, MyMD Pharmaceuticals, Inc.
again, Dr. Kaplin. In conclusion, the results of the Phase 2 study support the unique advantages of MYMD-1 as the first oral selective
TNF- inhibitor if approved, and a potential for future treatment options for sarcopenia and other autoimmune conditions with large
markets such as rheumatoid arthritis.
has been shown to selectively block TNF- when it becomes overactivated in autoimmune diseases and cytokine storms, but not block