Helperby’s Synergistic Combinations Beat AMR

Why Helperby succeeds when so many NCEs keep struggling

We develop approved anti-infective drugs into cost-effective combinations with synergistic anti-microbial activity to treat WHO Critical and High Priority Infections and reduce future antimicrobial resistance (AMR).

  • Regulatory approval in Year 3 vs. Year 11 for New Chemical Entities (NCEs); giving longer on-patent and off-patent sales as sales life is not shortened by AMR (as all single NCE antibiotics are).

  • Profitability in Year 4 vs Year 23 for NCEs, from > 10x lower costs, faster time to sales.

  • Implemented by an experienced team with proven business, commercial and development expertise in “virtual” business, avoiding unsustainable costs/time/risk of in-house infrastructure with established manufacturing and sales partners.

  • WORLDWIDE INTERLINKED PROBLEMS

    · Critical resistance of life-threatening pathogens growing worldwide, but poorly understood

    · O’Neill review (1) predicted AMR to cause 10M deaths/year by 2050; above cancer at 8.2M

    · Too few new antibiotics, too narrow use AND continued AMR despite large R&D costs/time cannot keep pace with AMR developing by natural mutations in all bacteria

    · Financial failure from unrecoverable costs vs. sales of NCE antibiotics from such limited use & life has significantly reduced investment

  • HELPERBY'S UNIQUE SOLUTIONS

    · Reduce emergence of AMR by using combinations of two or more synergistic anti-infective drugs

    · Treat life-threatening hospitalised patients in WHO Critical and High Priority infections

    · Able to treat infections caused by Carbapenem Resistant Gram-negative bacteria, including strains with no effective treatment today, without causing future AMR

    · Achieve profitability at acceptable price from reduced costs/risks of approved anti-infectives

  • PRODUCT HIGHLIGHTS

    · First three combinations of approved anti-infectives target multiple infection types associated with top 5/6 infections/infecting species

    · Includes urinary tract (cUTI) and skin and soft tissue structure (ASSSI) , pneumonia(HA/VABP) and bloodstream infections (BSI)

    · Global development

    · Unique products prevent AMR by known mechanisms, so broader, longer use-life achieved

    · Already approved products remove nee3d for toxicology and early clinical trials with a single Ph III study required

    · Ph III study supported by pre-clinical and in vitro microbiology data for US NDA by 505b and same EU filing routes; already proven by other combinations

PROBABILITY OF SUCCESS: 6.7x higher than NCEs as combining  approved drugs remove stages where failure of NCEs occur; including toxicology (69%) and Ph II clinical (40%) failure of NCEs(2), giving all stages at 67% success (as typical Ph III) for Helperby Combinations.

1) https://amr-review.org

2) Sertkaya A et al Analytical Framework for Examining the Value of Antibacterial Products; contracted to ERG by FDA Department of Health and Human Services 15 Apr 2014

To discuss our latest funding round, please contact our investor relations team