PIONEERING A NEW APPROACH TO THE OPIOID CRISIS

INTRODUCTION

  • Unmet Need:Every year, millions of US surgical patients experience opioid-induced respiratory depression (OIRD) severe enough to require prolonged mechanical ventilation and longer hospital stays
  • Problem:Current drug for OIRD, Naloxone, restores breathing but is problematic, and therefore used infrequently, because it  reverses pain relief
  • Solution:New drug, ATLX-0199 (sometimes referred to as Sudaxine), reverses OIRD while preserving pain relief
  • Market:Over 1$ billion annually
  • Technology:Proprietary small molecule platform; strong animal data; NIH-backed
  • Team:Experienced, industry-known, motivated, committed
  • Stage:Late pre-clinical

THE PROBLEM

While useful in controlling pain opioids have significant limitations:

  • Life-threatening respiratory and cardiovascular reactions
  • Withdrawal/tolerance/addiction
  • GI (motility) disruption
  • Potential for mass casualties

Opioid-induced side effects have created unmet medical needs of crisis proportion, affecting millions of people annually.

THE PROBLEM: OIRD

46% of patients receiving opioids during and following surgery experience opioid-induced respiratory depression (OIRD)*:

  • OIRD is a life-threatening side effect of opioids characterized by respiratory depression or cardiac collapse
  • It affects millions of hospital patients every year
  • OIRD extends hospital stays by 3 days on average
  • Longer hospitalization increases costs by over $6,000
  • Our solution addresses a $1 billion market

OIRD in hospitalized patients is Atelerix’s first target indication for opioid-related unmet medical needs.

* Source: Medtronic Prodigy Study, 2020

THE PROBLEM: WEAPONIZATION

The opioid crisis has a new and even uglier dimension – weaponization – and the focused funding interest of the NIH and the United States military.

“These public health threat agents are highly toxic chemicals that could cause mass casualties after either deliberate terrorism-related release or inadvertently.”

– National Institutes of Health

Russian special forces soldiers are seen carrying out hostages killed by a highly potent weaponized opioid in a Moscow theatre after a three-day stand off with Chechen terrorists.

(Credit: Anton Denisov/AFP/Getty Images)

THE PROBLEM: ADDICTION / TOLERENCE / OVERDOSE / WITHDRAWAL

Overdose deaths from synthetic opioids (primarily fentanyl) have become a massive crisis, approaching 40,000 in 2019, and growing since COVID-19 :

Atelerix’s novel approach to opioid-induced unmet medical needs could potentially diminish the number of opioid-related deaths

CURRENT STANDARD HAS SIGNIFICANT DISADVANTAGES

Naloxone restores breathing but also:

  • Immediately reverses opioid analgesia, leaving surgical patients in pain
  • Short-acting, requiring frequent re-administration
  • Less effective against highly-potent, synthetic opioids
  • Can cause cardio-pulmonary arrest

Much of the on-going research for the treatment of OIRD directly targets opioid receptors, with limited results; Atelerix’s ATLX-0199 technology takes a different approach.

A BETTER SOLUTION

ATLX-0199, an active thiol-based compound from our platform of novel drugs, reverses opioid-induced side effects such as OIRD while preserving pain relief:

  • ATLX-0199 targets molecular pathways, modulating signals downstream from activated opioid receptors
  • Concept validated by extensive NIH-supported research/data
  • Atelerix is developing ATLX-0199 and other compounds in its pipeline to treat the range of opioid-induced side effects; first focus is OIRD in the hospital surgical setting

ATLX-0199 TARGET MARKET

Opportunity for OIRD in surgical setting is over $1 billion annually

  • 51 million Americans undergo inpatient surgery annually
  • 80% of surgical patients will receive opioids for their surgery
  • 46% of those patients will experience some level of OIRD
  • 4.7% of those patients will experience OIRD of a severity sufficient to qualify as an opioid-related adverse drug event (ORADE) – This represents our initial target market

“Adjusted for covariates, presence of an ORADE is associated with 32% higher cost of hospitalization, 45% longer post-operative length of stay, 36% lower odds of discharge home, and 2.2 times the odds of death.”*

*The Burden of OIRD-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients, Richard D. Urman, MD; J Patient Safety, March 2021

FUNDING TO DATE

Over $16 million in prior non-dilutive funding to Atelerix Scientific Co-founders

Company has exclusive option on resulting intellectual property