Terran Biosciences Announces Development of TerXT, a Combination of Xanomeline and Trospium Prodrugs for the Treatment of Schizophrenia, and Intends to Pursue Accelerated 505(b)(2) Approval Pathway
May 20 2024 - 8:30AM
Business Wire
Terran Biosciences Inc. ("Terran"), a biotech platform company
developing therapeutics and technologies for patients with
neuropsychiatric illnesses, has announced the development of TerXT,
a combination of novel prodrugs of xanomeline and trospium designed
to be long-acting treatments for schizophrenia. Terran has received
notice of patent claims found to be allowable from the United
States Patent and Trademark Office (USPTO) for the composition of
matter for the world’s first prodrugs of xanomeline.
To develop TerXT, Terran sought to overcome inherent
pharmacokinetic and physical property limitations of the compounds
xanomeline and trospium, such as poor colonic absorption and high
aqueous solubility, by utilizing a novel prodrug strategy. These
prodrugs were designed to enable fixed-dose combinations for
once-daily oral administration (“TerXT”) and long-acting
intramuscular injection with multi-month duration (“TerXT LAI”).
These new forms could potentially allow Terran to pursue
accelerated development and regulatory strategies such as the FDA
505(b)(2) approval pathway.
Recent clinical trials of an oral, twice-daily, fixed-dose
combination of xanomeline, a compound invented in the 1990s, and
trospium, invented in the 1960s, have demonstrated safety and
efficacy in treating schizophrenia. This combination has been
submitted to the FDA for approval on the 505(b)(1) path and is
currently undergoing FDA review, with a decision expected by
September this year. If the FDA approves the xanomeline/trospium
combination, Terran plans to pursue the rapid 505(b)(2) approval
pathway for TerXT and TerXT LAI. This regulatory pathway could
potentially enable Terran to use pharmacokinetic bridging studies
and leverage existing safety and efficacy data from completed
trials to bring Terran’s next-generation therapeutics to market
approximately five years after the first xanomeline/trospium
approval, helping to broaden access for patients, improve the use
profile, and increase affordability.
In order to successfully overcome the pharmacokinetic
limitations of xanomeline and trospium, Terran assembled a team of
the world’s experts in medicinal chemistry, resulting in over
10,000 new prodrugs designs. Terran’s PK modeling team developed a
predictive model of both xanomeline and trospium across a vast
spectrum of different formulation designs and release profiles to
determine the optimal pharmacokinetic parameters and ratios. Terran
utilized a team of 200 chemists to synthesize over 500 prodrugs,
which then underwent preclinical testing, including 285 in vitro
and 365 in vivo studies.
“We’ve seen the prodrug approach significantly improve
long-acting formulations of some of the most effective
antipsychotics to date, including Aristada®, Haldol® Decanoate, and
Invega Hafyera®, to the great benefit of patients,” said Sam Clark,
MD, PhD, Terran’s founder and CEO, and inventor on the patent.
“However, these improved forms were not developed until many years
after the original compounds were first approved; in some cases,
decades later. At Terran, we believe patients shouldn’t have to
wait for the latest technology and we believe that our prodrugs of
xanomeline and trospium will enable improvements in ease of use and
quality of life on a much more rapid timescale than has
historically been achieved.”
ABOUT TERRAN BIOSCIENCES
Terran Biosciences is a biotech platform company developing a
portfolio of therapeutics and technologies for patients with
neurological and psychiatric diseases. Terran has built a
CNS-focused, tech-enabled drug development platform and is rapidly
advancing a number of assets that include late-stage therapeutics
for schizophrenia, an FDA-cleared neuroimaging software platform,
and a drug design engine that has generated first-in-class and
best-in-class psychedelic-based therapeutics and novel prodrugs
optimized for patient use. Follow us on LinkedIn and X.
For more information on TerXT visit www.TerXT.com
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