Positive Phase 1 results for LTG-001, Latigo's
potential best-in-class non-opioid Nav1.8 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 Nav1.8 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
Tmax 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 Tmax 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.
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SOURCE Latigo Biotherapeutics