Dry AMD / Glaucoma First-to-Market Drugs

Industry

Healthcare

Company Type

Biotechnology / Life Sciences

Location

USA, Israel

Size

$5,000,000

Investment Type

Debt/Equity

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Helping Great Companies Grow

Overview

  • Galimedix Therapeutics, Inc. (“Galimedix”) is a Phase 2 biopharma company with a novel first-in-class drug with ground-breaking potential to slow or stop the progression of Glaucoma and dry AMD – neurodegenerative diseases and leading causes of blindness
  • Seeking up to $5 million to prepare for its launch of clinical studies aimed to test efficacy of Galimedix’ proprietary eye drops drug GAL-101 – addresses key components of neurodegeneration:  toxic oligomers of amyloid beta
    • reproducibly demonstrated >90% neuro-protection efficacy results in key animal studies
    • successfully completed Phase 1 clinical safety studies in 40 volunteers and 30 Glaucoma patients, with eye drop delivery of patented GAL-101 (formerly MRZ-99030) – no toxicity
    • eye drops have clear potential advantages in the market versus injections in patients’ eyes – safer, and with major compliance advantages
    • Phase 2 studies aim to slow progression by 25-30% in Glaucoma and dry AMD patients – if successful, would be a paradigm shift, with a novel and potentially superior treatment for these diseases
    • the bridge funding is expected to drive completion of all GMP materials and clinical preparations, and obtain FDA IND clearance in mid-2019 to launch Phase 2 efficacy clinical trials in H2/2019, with optimized, streamlined study designs from top world experts, while raising Series A to fund the trials through completion
Helping Great Companies Grow

Opportunity

  • Glaucoma and Dry AMD are the leading causes of blindness in the industrialized world, now recognized as neurodegenerative diseases, with major unmet need for effective treatments that slow or stop the disease progression
    • Glaucoma – No treatments available directly aimed at halting or slowing the degeneration and death of Retinal Ganglion Cells (RGCs) which results in vision loss – all current treatments only reduce associated elevation in eye pressure; there is an unmet need for therapies that can directly promote RGC health. Global market potential is projected to reach $6 billion in 2026
    • Dry AMD – No approved treatments to prevent degeneration and death of photoreceptors or the retinal epithelial cells that support them – only new drug programs in clinical studies are via frequent serial injections to the eye, which are years away from product approval, (if ever). Global market estimated over $30 billion
Helping Great Companies Grow

Solution/Strategy

Galimedix has developed a unique first-in-class, potentially disruptive technology to treat the underlying causes of Glaucoma and Dry AMD blindness, using eye drops delivering a patented small molecule drug, GAL-101 (formerly MRZ-99030), and also has a next generation oral version GAL-201

  • GAL-101 addresses a key step in the pathogenesis of Glaucoma and Dry AMD by preventing the formation of toxic oligomers of beta amyloid, and thus prevents damaging effects to neurons, which cause reduced visual function and eventual blindness
    • Uses eye drops to deliver a unique small molecule drug which addresses the latest recognized Mechanism of Action causing both Glaucoma and Dry AMD
    • Major potential safety and compliance advantages versus injections in patients’ eyes
    • Demonstrated outstanding neuro-protection results in animal studies
    • Successfully completed Phase 1 studies
    • Optimized phase 2 clinical trials to prove efficacy slated to start in H2/2019
Helping Great Companies Grow

Management

Andrew Pearlman PhD

Founder, Chairman, & CEO

Biophysicist with 30+ years founding and leading early-stage biotechnology and medical device companies in Israel, with collaboration, funding and co-development partners globally. Licensed, invented and developed medical devices and biomedical technologies, from business and product conception through technology development, IP, prototyping, clinical trials, regulatory approval and product sales.  Founder and CEO of Medgenics, which developed a unique autologous protein therapy platform for sustained protein production using the patient’s skin dermis tissue. Led Medgenics through its IPO in the U.K. and U.S., and listing on the NYSE, reaching market capitalization over $300m. Founded and served as CEO and Chief Scientist for TransScan Research & Development Co., Ltd. PhD in Biophysics from the University of California at Berkley (doctoral thesis under Nobel Laureates – Professors Melvin Calvin and Donald Glaser).

Hermann Russ  MD and PhD

CSO

20 years of Pharma industry experience. Board-certified clinical neurologist, a board-certified experimental pharmacologist and pharmacist. Prior to joining Galimedix, Vice President of Neuroscience Project Leadership in Specialty R&D at Teva Pharmaceuticals International GmbH (TPIG) Switzerland. Responsibilities included the strategic leadership of “project champions” across a global cross-functional drug development programs in CNS and pain. Swiss Board of TPIG as Managing Officer. Head of Global R&D CNS at Merz Pharma, led an R&D in Neurology and Psychiatry. Head of the Medical Center of Excellence CNS at Merck KGaA. Inventor of the use of former Alzheimer-targeting molecule MRZ-99030 in the treatment of degenerative diseases in the retina including Dry AMD and Glaucoma. Co-inventor of the so-called” trigger effect” of MRZ-99030 and MRZ 14042, a unique reverse prion like self-propagation mechanism of action important for the clinical treatment regimen. Championed Galimedix assets GAL-101 (MRZ-99030) and GAL-201 (MRZ 14042) when they were being developed by Merz. PhD in Neuro- and Biochemistry from the University of Wurzburg. Academic career at the Universities of Wurzburg, Regensburg and Giessen – various positions in Clinical Neurology and Professor of Pharmacology. Scientific focus on neurodegenerative diseases, including Alzheimer’s, Parkinson`s, and degenerative retina diseases. 25 patents and around 50 peer-reviewed scientific publications.

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