Clinical Trials

EOM613 has already demonstrated clinical improvements in various disease states, and immune-related biomarkers and general tolerability across five Phase 2 clinical trials in patients with cachexia associated with AIDS and cancer and in patients with rheumatoid arthritis. These trials are summarized in the Table below.

EOM613

Upcoming Clinical Trials of EOM613

COVID-19 tissue and organ damage that leads to patient fatalities may be associated with hyperinflammatory effects and the release of large amounts of cytokines and chemokines in the body. Phase 2 clinical trials for EOM613 are planned for Q1 2021 to address the most severe effects of COVID-19.

The potential regulatory pathway for approval includes Compassionate Use, Emergency Use Authorization (EUA) and Fast Track Designation by the U.S. Food and Drug Administration (FDA).

Completed Clinical Trials of EOM613*

Disease/ Disorder, SourceStudy Type and Design# of PatientsEfficacy FindingsSafety/Tolerability Findings
HIV/AIDS-Associated Cachexia1 (Levett et al., 2002)

Study Type and Design

  • Phase 1/2, randomized, double-blind, placebo-controlled trial
  • Treatment until day 60, follow-up until day 120
  • Conducted in Barbados

# of Patients

  • 43 (21 EOM613, 22 placebo)

Efficacy Findings

  • CD4 lymphocyte counts increased vs baseline more in EOM613 group vs placebo group (p=0.013)
  • 4 EOM613 patients (but no placebo patients) had significant viral load declines
  • Body weight increased vs baseline in EOM613 group (p=0.003) whereas placebo group had a mean weight loss (p=0.003 for group difference)
  • Episodes of opportunistic infections lower in the drug-treated group (6 in 3 patients) vs. placebo (11 in 8 patients) (p=0.076)

Safety/Tolerability Findings

  • EOM613 injections generally well tolerated
  • Some patients reported transient mild pain at injection site
  • No toxic effects of EOM613 reported by patients or observed by physicians
AIDS / Cancer Cachexia2 (D’Olimpio et al., 2004)

Study Type and Design

  • Phase 1/2, open-label dosing trial
  • Conducted in Israel under Ministry of Health IND

# of Patients

  • 12 cachectic patients (10 with AIDS, 2 with pancreatic cancer) given EOM613 0.4 mL/d for 28 days
  • 5 additional AIDS patients were given EOM613 2.0 mL/d
  • Patients were followed for 28 days after 28-day treatment was completed

Efficacy Findings

  • AIDS:
    • At 0.4 ml dose, 70% of patients had slight weight gain or stabilization, all had increases in appetite by week 4, 60% reported increased energy and activities of daily living (ADL), mean strength increase was 8%, 70% had increased body fat
    • At 2ml dose, patients improved appetite by week 2, with mean body fat increase of 25%, and strength increase of 32%, all had improved energy and ADL by week 3
  • Pancreatic Cancer:
    • At 0.4ml dose, both patients had improved weight, percent fat and strength during 28-day treatment period

Safety/Tolerability Findings

  • No adverse events were noted in either group of patients
Cancer Cachexia3 (D’Olimpio et al., 2009)

Study Type and Design

  • Phase 2, open-label trial
  • Initial treatment for 28 days followed by evaluation (Phase A)
  • Patients showing benefit in Phase A allowed to continue therapy (Phase B)
  • Conducted in United States

# of Patients

  • 16 enrolled patients with advanced cancer and cachexia

Efficacy Findings

  • As of this report, 7 patients completed Phase A and chose to continue with EOM613 treatment (phase B)
  • 7/7 and 6/7 patients improved in anorexia and Patient Generated Subjective Global Assessment, respectively
  • 5/7 patients experienced weight stabilization or gain

Safety/Tolerability Findings

  • EOM613 was well tolerated and no serious side effects were reported
Cancer Cachexia4,5,6 (Chasen et al., 2010 and 2013)

Study Type and Design

  • Phase 2, open-label trial
  • Initial treatment for 28 days followed by evaluation (Phase A)
  • Patients showing benefit in Phase A allowed to continue therapy (Phase B)
  • Conducted in Canada

# of Patients

  • 29 enrolled patients with advanced cancer and cachexia

Efficacy Findings

  • 18 patients completed Phase A and 11 of them continued in Phase B up to 153 days
  • Stabilization of weight, lean body mass and body fat
  • Appetite increased (p=0.001) and total PG-SGA scores improved significantly (p=0.025)
  • Enhanced quality of life and Karnofsky Performance Status

Safety/Tolerability Findings

  • EOM613 was well tolerated with minimal side effects
Rheumatoid Arthritis (RA)7 (ADVR press release, 2003)

Study Type and Design

  • Phase 2, open-label trial
  • Patients given EOM613 1 mL twice daily for 15 days, then once daily for 75 days
  • Conducted in Argentina

# of Patients

  • 27 patients who met American College of Rheumatology criteria for mid to moderately severe RA

Efficacy Findings

  • After 3 months of EOM613 therapy, all patients:
    • Responded with amelioration of symptoms
    • Had a significant decrease in joint pain
    • Had increased mobility of the joints
    • Showed objective signs of decreased inflammation of affected joints
    • Considered efficacy as excellent

Safety/Tolerability Findings

  • No major side effects observed or reported
  • All patients considered tolerability as excellent

*In these and other past reports, EOM613 has had other names, including Product R, OHR118, AVR118, and OHR/AVR118.

EOM147 is a first-in-class small molecule anti-angiogenic drug with a novel intracellular mechanism of action for the treatment of proliferative diabetic retinopathy, branch and central retinal vein occlusions, and wet age-related macular degeneration (AMD). The novel formulation represents a potential breakthrough because it does not require intraocular injection into the eye and, if approved, would be the first topically administered eye drop to treat retinal diseases.

EOM147

Upcoming Clinical Trial of EOM147

EOM Pharmaceuticals is planning Phase 2 ophthalmic trials to be conducted for macular edema in patients with diabetic retinopathy and in wet age-related macular degeneration (wet-AMD) with the novel formulation of EOM147 to be conducted at sites in Mexico and India. The eye drop will be used as monotherapy, without adjunctive intraocular injections being administered.

An additional trial is planned for the use of EOM147 eye drop in branch and central retinal vein occlusions (BRVO and CRVO) in the United States, based on the promising results obtained in a previous investigator-initiated trial in 20 patients.

Completed Clinical Trials of EOM147*

Disease/ Disorder, SourceStudy Type and Design# of PatientsEfficacy FindingsSafety/Tolerability Findings
Macular edema due to retinal vein Occlusion1 (Wroblewski and Hu, 2016)
  • Phase 1, proof-of-concept study
  • Single-center, open-label randomized trial
  • Patients treated with topical squalamine (OHR102) and intravetral ranibizumab for 10 weeks, followed by randomization to continue or discontinue squalamine
20 treatment-naïve patientsAt week 38, best-corrected visual acuity improved mean best-corrected visual acuity significantly more in patients who continued squalamine vs stoppedSqualamine and ranbizumab were well tolerated

*In this and other past reports, EOM147 has had other names, including OHR-102

Published Articles

Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV. Levett PN, Hirschman SZ, Roach TC, Broome H, Alexander RJ, Fraser HS. HIV Clin Trials. 2002 Jul-Aug;3(4):272-8. doi: 10.1310/N34A-653T-ABF5-8Q1R. PMID: 12187500.

Anti-cachectic effects of a novel peptide nucleic acid: Preliminary results of a phase I/II clinical trial. D’Olimpio JT, Hirschman SZ, Shtemer Z, Didiego M. DOI: 10.1200/jco.2004.22.90140.8087 (presentation abstract). Journal of Clinical Oncology. July 15, 2004; 22, no. 14_suppl 8087-8087.

Phase II study of AVR118 in the management of cancer related anorexia/cachexia. D’Olimpio JT, Chasen MR, Sharma R, Diego M, Gullo V, MacDonald N.  DOI: 10.1200/jco.2009.27.15_suppl.e20631 (presentation abstract). Journal of Clinical Oncology 2009; 27, no. 15_suppl., e20631-e20631.

A Phase II study of OHR/AVR118 in anorexia-cachexia. Chasen M, Bhargava R, Hirschman SZ, Taraporewala IB. Poster presentation at: the 7th Cachexia conference, Kobe/Osaka, Japan, December 9-11, 2013.

Phase II study of OHR/AVR118 in anorexia-cachexia. Chasen M, Bhargava R, Hirschman SZ, Taraporewala I. Abstract of poster presentation at the 7th Cachexia conference, Kobe/Osaka, Japan, December 9-11, 2013. J Cachexia Sarcopenia Muscle 2013;4(4):335-6.

Phase II study of the novel peptide-nucleic acid OHR118 in the management of cancer-related anorexia/cachexia. Chasen M, Hirschman SZ, Bhargava R. J Am Med Dir Assoc. 2011 Jan;12(1):62-7. doi: 10.1016/j.jamda.2010.02.012. Epub 2010 May 15. PMID: 21194662.

Phase II study of the novel peptide-nucleic acid AVR118 in the management of cancer-related anorexia/cachexia. Chasen M, Hirschman SZ, Bhargava R. Abstract of poster presentation at the 5th Cachexia conference, Barcelona, Spain, December 5-8, 2009. J Cachexia Sarcopenia Muscle 2010;1(1):98-9.

Activation of human monocytes/macrophages by OHR/AVR118 promotes both pro– and anti-inflammatory phenotypes. Hirschman SZ. Adv Biosci Biotch. 2014; 5:161-8.

Dawn of antioxidants and immune modulators to stop HIV-progression and boost the immune system in HIV/AIDS patients: An updated comprehensive and critical review. Singh G, Pai RS. Pharmacol Rep. 2015 Jun;67(3):600-5. doi: 10.1016/j.pharep.2014.12.007. Epub 2014 Dec 24. PMID: 25933975.

Topical Squalamine 0.2% and Intravitreal Ranibizumab 0.5 mg as Combination Therapy for Macular Edema Due to Branch and Central Retinal Vein Occlusion: An Open-Label, Randomized Study. Wroblewski JJ, Hu AY. Ophthalmic Surg Lasers Imaging Retina. 2016 Oct 1;47(10):914-923. doi: 10.3928/23258160-20161004-04. PMID: 27759857.

IL-8 and MCP-1 secretion is enhanced by the peptide-nucleic acid immunomodulator, Product R, in U937 cells and primary human monocytes. D A Lazzarino, M de Diego, S Z Hirschman, K Y Zhang, S Shaikh, E Musi, L Liaw, R J Alexander. Cytokine. 2001 May 21;14(4):234-9. PMID: 11448124  DOI: 10.1006/cyto.2001.0867.

Advanced Viral Research Corp (ADVR). ADVR reports AVR118 inhibits inflammatory arthritis in animal model and in rheumatoid arthritis patients in human clinical trial. ADVR press release, PR Newswire, December 3, 2003.