HIV Wasting Syndrome

Dr. Douglas Brings Over 30 Years of Successful Drug Development Experience to EOM and will Chair EOM's Scientific Advisory Board, Leading Development of EOM613 [22-July-2021] MONTVALE, N.J., July 22, 2021 /PRNewswire/ -- EOM Pharmaceuticals, Inc., a privately held, clinical-stage company, today announced the appointment of Frank L. Douglas, Ph.D., M.D., to Scientific Advisor. Dr. Douglas will be responsible for guiding the company's clinical and scientific strategies for EOM lead candidate EOM613, as well as forming and chairing the EOM Scientific Advisory Board (SAB), which will include identifying other leading experts in the field of immunology and drug development. EOM613, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. Dr. Douglas is an accomplished industry veteran with more than three decades of experience in healthcare, pharmaceuticals, and entrepreneurship. Dr. Douglas has held leadership roles in both large and small biopharmaceutical companies, including serving as a member of the Board of Management and EVP responsible for Research, Development and Regulatory Affairs for Aventis SA, now Sanofi SA. He has led teams responsible for the development and marketing approval of many drugs across multiple therapeutic areas, including billion-dollar brands Allegra®, Lantus®, and Taxotere®. "We are pleased to welcome Dr. Douglas to the EOM team," said Irach B. Taraporewala, Ph.D., EOM Chief Executive Officer and Director. "His extensive proven experience and leadership in the pharmaceutical industry will serve as a significant strategic resource for EOM as we continue to focus on the development of EOM613 as a potential treatment for the most severe effects of COVID-19 as well as for cachexia." In addition to his drug development leadership roles, Dr. Douglas has held several academic positions. He was Professor of the Practice in several departments, including the MIT Sloan School of Management, the Harvard-MIT Health Sciences and Technology Program, and the MIT Department of Biomedical Engineering. He also was the founder and first executive director of the MIT Center for Biomedical Innovation, which addresses challenges in the global biomedical industry through collaborative research among industry, academia, and government. Dr. Douglas is the recipient of numerous prestigious awards, including the Weill Cornell Medical College Alumni Special Achievement Award in 2016 and the National Organization for the Professional Advancement of Black Chemists and Chemical Engineers (NOBCChE) Lifetime Achievement Award in 2002. He also is a champion of diversity and inclusion and is a leading voice in the pharmaceutical industry to ensure clinical trials are representative of all relevant patients. "I am excited to be joining EOM Pharmaceuticals at such a critical time in the planning for development of EOM613, which showed promise in early clinical studies in AIDS cachexia and rheumatoid arthritis, and I believe EOM613 has the potential to change the way we think about how immunomodulators impact the body during a cytokine storm," said Dr. Douglas. "I am looking forward to contributing to the clinical development of EOM613." For more information, please visit . About EOM613 EOM's lead asset, EOM613*, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. In human cell culture studies, EOM613 demonstrated a unique "dynamic dual action" by suppressing or stimulating monocytes and macrophages depending on the activation state and environment of those key immune cells.[1],[2],[3] It is hypothesized that this dynamic dual-action may overcome a limitation of many approved immunomodulators that only reduce the inflammatory state, without achieving immune system balance. EOM613 has a de-risked development program supported by promising early-clinical-stage safety and efficacy data across multiple therapeutic applications associated with hyperimmune responses, including cachexia associated with HIV/AIDS or cancer,[4],[5] and rheumatoid arthritis.[6] About EOM Pharmaceuticals EOM Pharmaceuticals is a privately held, clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The Company was founded with a specific vision to pursue innovative and accessible approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. *EOM613 has had other names, including Product R, OHR118, AVR118, and OHR/AVR118. Forward-Looking Statements This press release may contain forward-looking statements as such term is understood in the federal securities laws, including, among others, statements regarding the potential to develop a COVID-19 therapy. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in drug research and development. Any forward-looking statements in this press release speak only as of the date of this press release, and EOM Pharmaceuticals, Inc. undertakes no obligation to update or revise the statements in the future, even if new information becomes available. References 1 Hirschman SZ. Activation of human monocytes/macrophages by OHR/AVR118 promotes both pro- and anti-inflammatory phenotypes. Adv Biosci Biotch. 2014; 5:161-8. 2 Lazzarino DA, de Diego M, Hirschman SZ, Zhang KY, Shaikh S, Musi E, Liaw L, Alexander RJ. IL-8 and MCP-1 secretion is enhanced by the peptide-nucleic acid immunomodulator, Product R, in U937 cells and primary human monocytes. Cytokine. 2001 May 21;14(4):234-9. doi: 10.1006/cyto.2001.0867. PMID: 11448124. 3 Lazzarino DA, Diego M, Musi E, Hirschman SZ, Alexander RJ. CXCR4 and CCR5 expression by H9 T-cells is downregulated by a peptide-nucleic acid immunomodulator. Immunol Lett. 2000;74(3):189-195. doi:10.1016/s0165-2478(00)00258-3 4 Levett PN, Hirschman SZ, Roach TC, Broome H, Alexander RJ, Fraser HS. Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV. HIV Clin Trials. 2002 Jul-Aug;3(4):272-8. doi: 10.1310/N34A-653T-ABF5-8Q1R. PMID: 12187500. 5 Chasen M, Bhargava R, Hirschman SZ, Taraporewala IB. A Phase II study of OHR/AVR118 in anorexia-cachexia. Poster presentation at: the 7th Cachexia conference, Kobe/Osaka, Japan, December 9--11, 2013 6 Data on file, EOM Pharmaceuticals.

ROCKLAND, Mass., Feb. 9, 2021 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, presented retrospective HIV-associated wasting (HIVAW) prevalence and comorbidity data today from a claims database analysis at the Miami Center for AIDS Research (CFAR) Conference on HIV and Aging in the Era of ART and COVID-19. Results showed that the overall prevalence of HIVAW in the study population (N=42,587) was 18.3% (n=7804/42,587), including greater than one in 6 people being treated for HIV having a medical and/or pharmacy claim for HIV-associated wasting (also known as cachexia). HIV-associated wasting is a condition where HIV+ people taking medication can lose weight and lean body mass without trying and feel a loss of physical endurance. "Many physicians consider HIV-associated wasting no longer an existing comorbidity in the era of modern ART, but the evidence suggests otherwise and the continued need for on-going assessments of people living with HIV for weight loss," said Javeed Siddiqui, MD, MPH, Chief Medical Officer of TeleMed2U and the study's author. The data showed 19.1% (n=2933/15,345) of HIVAW patients were not taking ART, and 17.9% (n=4871/27,242) of HIVAW patients were taking ART. Antiretroviral therapy did not appreciably alter the prevalence of HIVAW. HIV+ patients with malignancies were excluded from the study to reduce bias. Additionally, the study revealed that the prevalence of HIV-associated wasting more frequently presented in patients of older age, male gender, history of more comorbidities and opportunistic infections. "Based on the data provided from this study, it appears that HIV-associated wasting remains prevalent in people with HIV, regardless of ART status," said Michael Harbour, MD, MPH and HIV/Endocrinology Medical Director at EMD Serono. "That's why additional studies are planned to further evaluate and understand this comorbidity." "EMD Serono has been a committed partner in the treatment of patients with HIV-associated wasting for nearly 25 years," said Andrew Paterson, President of EMD Serono and Global Head of the Innovative Medicine Franchises at Merck KGaA, Darmstadt, Germany. "Our involvement in this study underscores our continued dedication to helping people impacted by HIV." This medical and pharmacy retrospective claims analysis was conducted across US payer markets using IBM® MarketScan® Commercial, Medicare Supplemental and Medicaid Databases. It is important to note that real-world evidence does have limitations, including lack of randomization, less control over data collection, and less reliability/accuracy as compared to randomized controlled trials. Results were shared as an abstract at the Miami CFAR Conference on HIV and Aging in the Era of ART and COVID-19. About EMD Serono, Inc. EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for MS and other immunologic diseases. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. . Your Contact Melissa Beglin (781) 681-2609