Latigo Biotherapeutics Announces Positive Phase 1 Data for Lead Non-Opioid Pain Medicine Candidate and Appoints Neil Singla, M.D., Chief Medical Officer

Positive Phase 1 results for LTG-001, Latigo's potential best-in-class non-opioid Na_v1.8 inhibitor, demonstrated it to be well tolerated with rapid absorption

Dr. Singla brings world-class expertise in analgesics, pain management, and clinical development to accelerate Company's pipeline of non-opioid pain medicines

Opioid addiction is a national public health concern – 3.75 million Americans go on to long-term chronic opioid use after low-risk surgery as up to 19% of patients exposed to opioids develop dependency

THOUSAND OAKS, Calif., Aug. 19, 2024 /PRNewswire/ -- Latigo Biotherapeutics Inc. ("Latigo") today announced positive Phase 1 results for LTG-001, its lead potential best-in-class non-opioid pain medicine candidate. In a Phase 1 first-in-human clinical trial, data showed that LTG-001 was well tolerated with rapid absorption. LTG-001 is an oral, selective Na_v1.8 inhibitor in development to treat acute and chronic pain at its source. The Company also announced the appointment of world-renowned analgesic scientist Neil Singla, M.D., as chief medical officer.

"Opioid addiction is a national public health concern and Latigo Bio is dedicated to being part of the solution. Latigo intends to develop non-opioid drugs that have meaningful efficacy, rapid onset of action, and superior safety to standard of care with no central nervous system effects, thereby reducing the risk of addiction," said Nima Farzan, Latigo's chief executive officer. "These positive Phase 1 results of LTG-001 in healthy volunteers are encouraging and give us tremendous confidence we are moving in the right direction. We look forward to continuing to progress the clinical program for LTG-001 along with our robust pipeline so that we can provide alternatives for patients that reduce dependency and offer effective pain relief."

LTG-001 Phase 1 Clinical Trial Results
Results from the Phase 1 clinical trial in 72 healthy subjects showed that LTG-001 was well tolerated and demonstrated rapid absorption with a T_max of about 1.5 hours and predictable pharmacokinetics. Exposure was proportional across the dose range. Rapid onset of pain relief is critical for both acute and chronic pain management and achieving a T_max in under two hours in this study indicates this may be possible. Additionally, no food effect was shown in the studied doses. 

Latigo's Phase 1 first-in-human clinical trial was designed to evaluate the safety and tolerability of single- and multiple-ascending oral doses, relative bioavailability, and food effect of LTG-001 versus placebo in healthy subjects.

World-leading Analgesic Scientist Neil Singla, M.D., Appointed as Chief Medical Officer
Latigo also announced the appointment of world-renowned analgesic scientist Neil Singla, M.D., as chief medical officer. Dr. Singla is the founder and past chief executive officer of Lotus Clinical Research, a world-renowned analgesic site and Clinical Research Organization combination. An expert in analgesic protocol design and implementation with a deep focus on minimizing variability in clinical trials with subjective endpoints, Dr. Singla has been instrumental in pioneering methodologies that enhance the rigor and outcomes of pain management studies.

"Dr. Singla's extensive experience in analgesic protocol design and implementation will be invaluable as we work to address opioid addiction – one of the most critical public health issues of our time," said Mr. Farzan. "We look forward to Neil's leadership in advancing our pipeline of non-opioid pain medicines."

"Latigo's innovative approach to pain management can play a significant role in providing effective non-opioid therapies to patients," said Dr. Singla. "Latigo's mission aligns with my passion for advancing treatments for pain management, without the risk of dependency. I am honored to have the opportunity to work with the Latigo team to deliver these life-changing non-opioid alternatives to people who desperately need them."

Dr. Singla's innovative approach includes the development of novel patient education techniques that reduce placebo responses and increase effect sizes, significantly improving the quality of clinical trials in pain management. His work developing the abdominoplasty model for acute postoperative pain studies has set a new standard in the field, becoming a cornerstone for numerous new drug approvals.

As a respected figure in the scientific community, Dr. Singla chairs the Clinical Trials Special Interest Group for the International Association for the Study of Pain (IASP) and has organized and chaired prominent scientific symposia on analgesic trials for both the IASP and the American Pain Society. He earned his medical degree from Northeast Ohio Medical University.

About Opioid Use Disorder
The opioid crisis remains one of the most critical public health issues of our time, with opioid addiction, also known as opioid use disorder, posing a significant threat to millions. According to the American Medical Association, 3% to 19% of individuals in the U.S. exposed to opioids develop chronic dependency. The National Institute on Drug Abuse reports that more than 80% of individuals who use illicit opioids, particularly heroin, began with prescription opioids. Each year, in the U.S. approximately 10,000 people die from overdoses involving prescribed opioids, and this number increases to 75,000 when including deaths from illicit opioids. In the U.S. alone, 143 million opioid prescriptions were written in 2020, and more than 10 million people misused opioids in 2019. Additionally, 3.75 million patients transition to long-term chronic opioid use after low-risk surgeries annually. The risks associated with prescription opioids are multifaceted, encompassing accidental overdoses, the presence of unused opioids in homes, and the progression from dependency to the use of dangerous illicit drugs like heroin and fentanyl. These alarming statistics underscore the urgent need for effective, rapid-acting non-opioid pain therapeutics that provide safer pain management alternatives and mitigate the opioid epidemic.

About Latigo Biotherapeutics
Latigo Biotherapeutics is a private clinical-stage biotechnology company developing innovative non-opioid pain medicines with potential best-in-class profiles that directly target the source of pain. Latigo's goal is to provide effective, rapid-acting pain relief without the risk of addiction. Latigo is supported by leading investors including Westlake Village BioPartners, 5AM Ventures, Foresite Capital, and Corner Ventures. For more information, please visit www.latigobio.com or follow us on LinkedIn.

SOURCE Latigo Biotherapeutics