TNF Pharmaceuticals Presents Statistically Significant Phase 2a Trial Results for Novel Sarcopenia/Frailty Treatment at Prestigious International Conference

Rhea-AI Summary

TNF Pharmaceuticals (NASDAQ: TNFA) announced significant positive topline results from a Phase 2a study of MYMD-1® (isomyosamine) for sarcopenia treatment. The double-blind, placebo-controlled study in patients aged 65+ showed significant decreases in inflammatory biomarkers, including TNF-α (P=0.008), IL-6 (P=0.03), and sTNFR1 (P=0.02), with no serious adverse events reported.

Based on these results, the company plans to initiate a Phase 2b study in early 2025. The global TNF inhibitor market is valued at $39.7 billion in 2024, expected to reach $47.3 billion by 2029. The sarcopenia treatment market, currently at $3.07 billion, is projected to grow to $4.02 billion by 2029, with over 50 million people affected globally.

Positive

• Statistically significant Phase 2a results showing reduction in key inflammatory biomarkers
• No serious adverse events reported in the clinical trial
• Targeting a $40 billion TNF inhibitor market
• Addressing an unmet medical need with no current FDA-approved treatments for sarcopenia
• Large market potential with 50 million affected patients globally

Negative

• Phase 2b trials not starting until 2025, indicating longer timeline to market
• Will require significant additional clinical trials before potential FDA approval

Insights

Medical Research Analyst

The Phase 2a trial results for MYMD-1 demonstrate compelling statistical significance in treating sarcopenia, with notable P-values across key inflammatory biomarkers (TNF-α: P=0.008, IL-6: P=0.03, sTNFR1: P=0.02). The oral delivery method represents a potential breakthrough in TNF-α inhibition, traditionally to injectable formulations. The absence of serious adverse events in the elderly population (65+ years) is particularly encouraging for this demographic. The study's robust design as a double-blind, placebo-controlled trial strengthens the validity of these findings. The consistent biomarker improvements across multiple timepoints during the 28-day treatment period suggest sustained therapeutic effect, which is important for chronic condition management.

Market Research Analyst

The market opportunity for MYMD-1 is substantial, targeting both the $40 billion TNF inhibitor market and the $3.07 billion sarcopenia segment. With sarcopenia affecting 50 million people and projected to reach 200 million in four decades, the growth potential is significant. The 3.6% CAGR in the TNF inhibitor market and 4.48% CAGR in sarcopenia treatment indicate robust sector growth. Being first-to-market with an FDA-approved sarcopenia treatment could capture significant market share, especially given the $40+ billion healthcare burden. The dual-market potential and first-mover advantage position MYMD-1 as a potentially transformative asset for TNFA.

Based on successful Phase 2a data, Company set to initiate Phase 2b sarcopenia study in early 2025; currently securing centers of excellence to begin enrollment

First oral TNF-α inhibitor, if approved, would offer potential patient benefit in an approximate $40 billion TNF inhibitor market

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, today announced that significant positive topline results from a Phase 2a study of its lead drug candidate MYMD-1® (isomyosamine) was presented at a prestigious international congress of global experts in sarcopenia and related disorders held December 6–8, 2024 in Washington, D.C.

“In our view, MYMD-1 could become a consequential therapeutic solution for patients not served by current TNF-alpha inhibitors,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “With no FDA-approved treatments available to sarcopenia/frailty patients that target this disease itself, there is a large unmet medical need for effective therapies. Plus, the estimated $3 billion sarcopenia treatment market is just a subset of the broader TNF inhibitor market which was estimated to be $40 billion in 2024.

“Based on the positive results from our MYMD-1 Phase 2a study, we are set to launch a Phase 2b study in sarcopenia/frailty early in the first quarter of 2025,” Dr. Glass added.

The presentation, ‘Isomyosamine for the Treatment of Sarcopenia in Elderly Population,’ describes the results of a double-blind, placebo-controlled study in patients aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. Subjects in the trial who were given once daily oral doses of MYMD-1 showed significant decreases in several biomarkers attributed to chronic inflammation, including tumor necrosis factor-alpha (TNF-α) (P=0.008), Interleukin-6 (IL-6) (P=0.03) and soluble TNF-α receptor 1 (sTNFR1) (P=0.02) at several timepoints throughout the 28 days of treatment. No serious adverse events were reported.

The global market value for TNF inhibitors was estimated to be $39.7 billion for 2024. Growing at an expected 3.6% CAGR for the next five years, the TNF inhibitor market is expected to reach $47.3 billion by 2029.¹

Sarcopenia is the progressive loss of muscle mass and strength primarily due to aging. Based on conservative calculations, at least 50 million people were affected by sarcopenia in 2018, and the disease is projected to affect over 200 million over the next four decades due to the growing elderly population.² The sarcopenia treatment market is estimated to be $3.07 billion in 2024 and is expected to grow at a CAGR of 4.48% to $4.02 billion by 2029.³

Approximately 10% to 16% of the elderly worldwide suffer from sarcopenia.⁴ In addition to the elderly, sarcopenia is estimated to affect more than 1 in every 10 young adults of most ethnicities.⁵ With no FDA-approved treatments for sarcopenia itself, as opposed to its symptoms, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system.⁶

The 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders joins researchers, clinicians, academic experts, investigators and industry leaders from around the world. SCWD is a non-profit scientific organization comprised of an international and multidisciplinary group of healthcare professionals primarily active in these fields.

About MYMD-1^®

MYMD-1® (isomyosamine) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNFα plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), 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 treat diseases and disorders marked by acute or chronic inflammation. 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. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ Mordor Intelligence, TNF Inhibitors Market Size (2024 - 2029)

² Biology, Sarcopenia Is Associated with an Increased Risk of Postoperative Complications… (2023)

³ Mordor Intelligence, Sarcopenia Treatment Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

⁴ Metabolism journal, Epidemiology of sarcopenia: Prevalence, risk factors, and consequences (2023)

⁵ Metabolism journal, Sarcopenia in youth (2023)

⁶ Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019)

View source version on businesswire.com: https://www.businesswire.com/news/home/20241209916402/en/

Investor Contact:

Robert Schatz

(646) 421-9523

rschatz@tnfpharma.com

www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

FAQ

What were the key results of TNFA's Phase 2a trial for MYMD-1?

The trial showed significant decreases in inflammatory biomarkers including TNF-α (P=0.008), IL-6 (P=0.03), and sTNFR1 (P=0.02), with no serious adverse events reported.

When will TNFA begin its Phase 2b trial for MYMD-1 in sarcopenia treatment?

TNF Pharmaceuticals plans to initiate the Phase 2b trial in early 2025.

What is the market size for TNF inhibitors that TNFA is targeting?

The global TNF inhibitor market is valued at $39.7 billion in 2024 and is expected to reach $47.3 billion by 2029.

How many people are affected by sarcopenia globally?

At least 50 million people were affected by sarcopenia in 2018, with projections showing over 200 million affected in the next four decades.