Noitami Therapeutics

Noitami's Science-Based Approach

Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management

Introduction

The management of acute postoperative pain remains a significant challenge for physicians
Poorly controlled postoperative pain is associated with weaker overall outcome

Conclusion (based on 501 surveyed physicians):

Opioids remain an integral component of multimodal acute analgesic therapy for acute postoperative pain
There remains a key unmet need for effective analgesic medications that are associated with a lower risk of adverse effects, e.g., nausea, vomiting, respiratory depression, addiction…

What Makes AAT-076 Unique?

Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management

We believe AAT-076 is the first and only compound with an opportunity to determine the clinical significance of CNS Cyclooxygenase-2 (COX-2) inhibition at therapeutic doses.

Phase 1 and Phase 2 clinical study results in the U.S.
Safe, well-tolerated up to 360 mg, 10 days up to 180 mg/day
Superior efficacy vs. Ibuprofen, i.e., onset, potency, and duration
Potential for reducing opioids, renal and GI safety advantages
Intellectual Property (Patent) Status
Multiple patents granted worldwide. Last patent expires in 2040
Exclusivity beyond 2040 possible based on a new formulation patent to be filed in 2024

AAT-076: Potential Best-in-class Non-Opioid Analgesic Drug for Acute Pain

Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management

AAT-076: Potential Best-in-class Non-Opioid Analgesic Drug for Acute Pain

A Powerful, Safe, Non-Opioid

Pain Medication

AAT-076 demonstrated strong, differentiated pain control in wisdom tooth extraction in a Phase 2 clinical trial.

Superior Pain Relief: Fast & All Day Pain Control in a Phase 2 clinical trial

Superior to Ibuprofen in a Phase 2 clinical trial
One pill provides > 24 hours of pain control in a Phase 2 clinical trial
> 60% patients rated AAT-076 as ”very satisfied” with pain relief v. 28% with Ibuprofen
80% of patients were satisfied with AAT-076 medication

Opioid Sparing

Potential for significant reduction in need for opioid use

Potential Safety Advantages

Renal and GI, and no platelet effect

COX-2 in the CNS Contributes to Inflammatory Pain

AAT-076: Potential Best-in-class Non-Opioid Analgesic Drug for Acute Pain

Optimal analgesic therapy with COX-2 inhibitors should include targeting central COX-2 by promoting brain penetration
The use of centrally acting COX-2 inhibitors might represent diverse means of normalizing pain sensitivity

Pain Medication Approval and FDA Draft Guidance

COX-2 in the CNS Contributes to Inflammatory Pain

Pain Medication Approval and FDA Draft Guidance

Celecoxib (Dec. 1998) is one of the last major non-opioid drugs approved by the FDA for acute postoperative pain
Opioids and combination drugs have been approved, however, none meeting the “medical need”
- Over prescription of opioids
On Feb. 2022, FDA issued new draft guidance on development of non-opioid analgesics
- FDA is committed to combating the opioid crisis by fostering the development of novel analgesic drugs

Welcome to Noitami Therapeutics

Noitami’s lead compound, AAT-076, a third-generation, CNS-active Cox-2 inhibitor with unique structure and global IP protection, was discovered by the same Pfizer team that developed Celebrex, as a superior follow-on candidate. AAT-076 has demonstrated strong, differentiated pain control over existing selective Coxibs as well as non-steroidal anti-inflammatory drugs (NSAIDs) in wisdom tooth extraction in a Phase II clinical trial. Following Merck’s decision to withdraw Vioxx from the market in September 2004, the pharmaceutical sector halted nearly all pain research and development. In the ensuing decades, the lack of fast-acting, efficacious medication for acute pain has contributed to the explosion of opioid addition in the United States and other countries. Evidence shows common procedures, including dental surgery and broken bone repair are a significant on-ramp to opioid use and abuse among younger patients. Poorly managed acute pain control has been consistently shown to be a predictive factor for development of chronic pain. There is thus a huge, unmet market need for safe, fast, and lasting post-operative pain control. In North America alone, the pain management market is estimated to reach over $43 billion by 2027, with a compound annual growth rate of 3.5 percent. Noitami’s plan is to develop AAT-076 to a new drug application pivotal study-ready point in two years.

Meet Our Leadership Team

Atsushi Nagahisa, PhD CEO & Co-Founder

Jaime Masferrer, PhD Chief Scientific Officer & Co-Founder

Dr. Atsushi Nagahisa is a founding member of Noitami, AskAt Inc., and a founder of RaQualia Pharma Inc., with over 35 years of experience in drug discovery, development and management. He raised $111 million to launch RaQualia, the first, organic spin-out in Pfizer’s history, and then an additional $83 million in a 2011 public offering on the JASDAQ. He served as President and CEO from its formation in 2008 through August 2012. Dr. Nagahisa has held senior management positions at Pfizer Global R&D and Pfizer Japan, and lead laboratories that discovered Cerenia® and Galliprant®. Nagahisa served on the Board of Ikena Oncology, with a successful NASDAQ IPO in March 2021. He holds a Ph.D. in Biochemistry from the Massachusetts Institute of Technology and a B.A. in Biochemistry from Reed College.

Show Less

Jaime Masferrer, PhD Chief Scientific Officer & Co-Founder

Dr. Jaime Masferrer is a founding member of Noitami and a drug hunter with over 30 years of experience in pharmaceutical R&D, including as Senior Research Fellow & Group Head for Translational Medicine for Pfizer Inc. He is one of the lead scientists that discovered Celebrex® for the treatment of arthritis and pain. Masferrer received the Monsanto Edgar Queeny Award in 2000 for excellence in science and technology. In 2002, he was awarded Pharmaceutical Research and Manufacturers of America (PhRMA) Discoverer’s Award for his work on the development of Celebrex®. Masferrer received his Ph.D. in Pharmacology from New York Medical College.

Show Less