OUR NEW PROFILE IS: (NASDAQ: MYMD)
RA AFFECTS UP TO 14 MILLION PEOPLE AROUND THE WORLD
MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS
MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY
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MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.
MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS
DECEMBER 06, 2023 9:15AM EST
Company targets first quarter 2024 for trial initiation
Potential to be first orally-administered TNF-α inhibitor treatment for RA
BALTIMORE–(BUSINESS WIRE)– MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024.
“With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase 2 trial within the next several months. Results from preclinical studies have demonstrated MYMD-1’s potential to treat RA, and we believe this drug could one day be a disruptor in the massive market for similar treatments,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD.
Differentiated by its ease of oral dosing and selectivity, MYMD-1 is a TNF-α inhibitor with a small molecule design that enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to widely used RA therapy Enbrel® (etanercept).1 Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection).
Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis. Patients will receive oral MYMD-1 dosing of 1050 mg.
Market Opportunity
Rheumatoid arthritis is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually.2
About MYMD-1
Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.
MYMD-1 has shown effectiveness in preclinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.
MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY
JULY 31, 2023 9:00AM EDT
– MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and tolerability endpoints across multiple doses over 28 days of treatment
– MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α(P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03)
– First Oral TNF-α inhibitor, if approved, would offer potential patient benefit in large markets
– Company to present the data to FDA and intends to advance the clinical program for MYMD-1; will hold conference call on August 2, 2023, at 4:30 PM Eastern Time
BALTIMORE–(BUSINESS WIRE)– MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or the “Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, today announced statistically significant positive topline results from its randomized Phase 2 study of oral TNF-α inhibitor, MYMD-1® in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. MYMD-1 has the potential to be the first drug approved by the United States Food and Drug Administration (FDA) for sarcopenia, an age-related decline in physical function which leads to greater risk of hospitalization, disability, and death.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230731983609/en/
The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events (AEs) or serious adverse events (SAEs) over the course of the study.
“We are very excited about these results indicating MYMD-1 demonstrated statistically significant reductions in all three inflammatory markers and met all additional pharmacokinetic and safety endpoints needed to advance our sarcopenia clinical program, with guidance from the FDA,” said Chris Chapman, M.D., President, Director, and Chief Medical Officer at MyMD. “These results support the unique advantages of MYMD-1 as the first oral, selective TNF-α inhibitor candidate and potential future treatment option for sarcopenia and other autoimmune conditions such as rheumatoid arthritis.”
The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) 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 elevated levels of proinflammatory cytokines. Patients in the study were dosed weekly with MYMD-1 or placebo over a 28-day period. The study consisted of four dosing cohorts versus placebo (600mg, 750mg, 900mg and 1050mg).
“We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF-α inhibitor,” continued Dr. Chapman. “Sarcopenia can significantly affect people as they age, and there are currently no approved treatments for the condition. A selective, oral treatment that reduces TNF-α and inflammation and does not require infusion or injection would be a welcome advance for this population.”
Full results from the study will be presented or published at a later date to be determined. The company plans to initiate discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia.
NEWS
DEC 06, 2023 9:15AM EST
MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS
OCT 04, 2023 7:30AM EDT
MYMD PHARMACEUTICALS TO PRESENT UPDATED STATISTICALLY SIGNIFICANT PHASE 2 DATA FOR MYMD-1, POTENTIAL TNF-Α MARKET DISRUPTER, AT BIOFUTURE 2023
AUG 14, 2023 8:30AM EDT
FDA ACCEPTS MYMD PHARMACEUTICALS’ INVESTIGATIONAL NEW DRUG APPLICATION (IND) FOR PHASE 2 STUDY OF ORAL TNF-Α INHIBITOR MYMD-1® IN RHEUMATOID ARTHRITIS (RA)
AUG 02, 2023 8:30AM EDT
MYMD PHARMACEUTICALS TO HOLD CONFERENCE CALL TODAY TO DISCUSS PHASE 2 TRIAL RESULTS
JUL 31, 2023 9:00AM EDT
MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY
APR 12, 2023 8:30AM EDT
MYMD PHARMACEUTICALS® PROVIDES DOSING UPDATE ON PHASE 2 MULTI-CENTER CLINICAL TRIAL OF MYMD-1® AS A THERAPY FOR DELAYING AGING AND EXTENDING HEALTHY LIFESPAN
MAR 20, 2023 8:55AM EDT
MYMD PHARMACEUTICALS® AND CHARLES RIVER PRESENT POSITIVE DATA FOR NEXT GENERATION, ORAL TNF-Α INHIBITOR MYMD-1® IN RHEUMATOID ARTHRITIS
MAR 08, 2023 8:30AM EST
MYMD JOINS LOT NETWORK IN EFFORT TO PROTECT COMPANY AND SHAREHOLDERS FROM PATENT TROLLS
MAR 02, 2023 8:30AM EST
MYMD ANNOUNCES U.S. DRUG ENFORCEMENT ADMINISTRATION (DEA) DETERMINES SUPERA-CBD™ IS NOT A CONTROLLED SUBSTANCE OR LISTED CHEMICAL
FEB 28, 2023 8:30AM EST
MYMD PHARMACEUTICALS® ANNOUNCES UPCOMING PRESENTATION OF PRECLINICAL RHEUMATOID ARTHRITIS DATA FOR ORAL TNF-Α INHIBITOR MYMD-1® AT THE SOCIETY OF TOXICOLOGY 2023 ANNUAL MEETING
MANAGEMENT TEAM
CHRIS CHAPMAN, M.D.
President, Chief Medical Officer and Director
Chris Chapman, M.D., was appointed as President and Chief Medical Officer of MYMD Florida effective as of November 1, 2020. Prior to joining MYMD Florida and since 1999, Dr. Chapman has also served as the Chief Executive Officer of Chapman Pharmaceutical Consulting, Inc., a consulting organization that provides support to pharmaceutical and biotech companies in North America, Europe, Japan, India and Africa on issues such as product safety, pharmacovigilance, medical devices, clinical trials and regulatory issues. In addition, from 2003-2004, Dr. Chapman served as the Associate Director of Drug Safety, Pharmacovigilance, and Clinical Operations for Organon Pharmaceuticals, where he was responsible for the supervision of four fellow M.D.s and 10 drug safety specialists. Prior to his time at Organon, Dr. Chapman served as Director, Medical Affairs, Drug Safety and Medical Writing Departments at Quintiles (currently known as IQVIA), from 1995-2003, where he grew the division from no employees to forty employees, including eight board certified physicians, four RNs, two pharmacists, eight medical writers and supporting staff. Dr. Chapman has also served on the board of directors of Rock Creek Pharmaceuticals, Inc. (f/k/a Star Scientific, Inc.) from 2007-2016, including as a member of the Audit Committee from 2007-2014, chairperson of the Compensation Committee from 2007-2014, and chairperson of the Executive Search Committee from 2007 to 2014. Dr. Chapman is an experienced executive and global medical expert and has extensive experience in providing monitoring and oversight for ongoing clinical trials including both adult and pediatric subjects. Dr. Chapman is also the founder of the Chapman Pharmaceutical Health Foundation, an IRS Section 501(c)(3) nonprofit organization established to solicit public funds and to support healthcare needs such as AIDS, diabetes, hypertension, lupus, sickle cell anemia, malaria and tuberculosis, which was organized in 2006. Dr. Chapman is a graduate of the Harvard Kennedy School of Cambridge, Massachusetts for financial management in 2020. Dr. Chapman received his M.D. degree from Georgetown University in Washington, D.C. in 1987, and completed his internship in Internal Medicine, a residency in Anesthesiology and a fellowship in Cardiovascular and Obstetric Anesthesiology at Georgetown.
ADAM KAPLIN, M.D., PH.D.
Chief Scientific Officer
Adam Kaplin, M.D., Ph.D., was appointed Chief Scientific Officer of MYMD Florida effective as of December 18, 2020. Prior to joining MYMD Florida, Dr. Kaplin has served in a number of positions at John Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, Director of the Johns Hopkins Ketamine Clinic and the Departments of Psychiatry & Neurology at Johns Hopkins University School of Medicine, positions he has held at various times from 2002 to present. In addition, since 2019, Dr. Kaplin has served as Adjunct Faculty at the George Mason University Department of Global and Community Health. Dr. Kaplin has also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways Inc., a company devoted to addiction treatment development focused on a combined eHealth and medicine approach to curing addiction, and from 2016 to present, Hollinger Kaplin Benjamin & Bond, an eHealth software development company. Dr. Kaplin’s research focuses on the investigation of the biological basis of immune mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin has also been active for over a decade in the development and application of health information technology to mental health, combining this work with providing neuropsychiatric consultation and ongoing care of patients with multiple sclerosis spectrum disorders. Dr. Kaplin’s original research has been published over 40 times in several different publications, and he has authored or co-authored numerous review articles and textbooks. Dr. Kaplin received his B.S. in Biology from Yale University, graduating cum laude in 1988, and received his M.D. and Ph.D. from the Johns Hopkins University School of Medicine in 1996.
PAUL RIVARD, ESQ.
Executive Vice President of Operations and General Counsel
Paul Rivard, Esq., was appointed Executive Vice President of Operations and General Counsel of MYMD Florida effective as of September 21, 2020. Prior to joining MYMD Florida, Mr. Rivard was a principal shareholder of Banner Witcoff, a national law firm specializing in intellectual property law, from 2003-2020, and in that capacity also served as Chair of the firm’s Prosecution Policies and Procedures Committee, developing and refining internal procedures, workflow, and docketing practices to improve efficiencies and mitigate risk. Before becoming a principal shareholder, Mr. Rivard was an associate at Banner Witcoff from 1998-2002. In addition, prior to his time at Banner Witcoff, Mr. Rivard served as a patent examiner for the United States Patent and Trademark Office from 1992-1998. Mr. Rivard brings more than 20 years of experience as intellectual property counsel for clients ranging from startups to Fortune 100 companies in the life sciences, chemical and consumer product industries, including primary outside intellectual property counsel for MYMD Florida from 2014-2020. Mr. Rivard has worked closely with strategic decision makers and in-house counsel of his numerous clients, seeking to align intellectual property procurement, enforcement and licensing strategies with business objectives. Mr. Rivard received his Juris Doctor from Catholic University of America’s Columbus School of Law, graduating cum laude in 1998, and his B.S. in Chemical Engineering from Clarkson University in 1992.
IAN RHODES
Chief Financial Officer
Ian Rhodes was appointed as Interim Chief Financial Officer on February 1, 2021. Mr. Rhodes joined Brio Financial Group (“Brio”) in January 2021. From March 2020 to December 2020, Mr. Rhodes served as the Interim CFO of Roadway Moving and Storage. From November 2018 to July 2019, he served as Interim CFO of Greyston Bakery and Foundation. From December 2016 to September 2018, Mr. Rhodes served as President, CEO and Director of GlyEco, Inc., and served as CFO of GlyEco, Inc. from February 2016 to December 2016. From May 2014 to January 2016, he served as CFO of Calmare Therapeutics. Mr. Rhodes began his career at PricewaterhouseCoopers, where he worked for 15 years. Mr. Rhodes holds a Bachelor of Science degree in Business Administration with a concentration in Accounting from Seton Hall University and is a licensed CPA in New York.
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