LYT-503/IMB-150

Our programs 1
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-503/IMB-150
(Imbrium collaboration) Non-opioid
IC/BPS

Preclinical

Interstitial cystitis/Bladder pain syndrome

~4-12M U.S.


Therapeutic candidate being developed for the potential treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) that is designed to selectively treat IC/BPS while minimizing the potential for related systemic toxicities by selectively targeting API pharmacology to inflamed tissue.

Phase completedPhase in progressRegistration-enabling development plans in progress

1 The FDA and corresponding regulatory authorities will ultimately review our clinical results and determine whether our wholly-owned therapeutic candidates are safe and effective. No regulatory agency has made any such determination that LYT-503/IMB-150 is safe or effective for use by the general public for any indication. On July 23, 2021, Imbrium Therapeutics exercised its option to license LYT-503/IMB-150 pursuant to which it is responsible for all future development activities and funding for LYT-503/IMB-150.

Non-opioid inflammation targeted disease immunomodulation for the potential treatment of interstitial cystitis, or bladder pain syndrome

LYT-503/IMB-150 is being advanced through a collaboration with Imbrium Therapeutics for the potential treatment of interstitial cystitis or bladder pain syndrome (IC/BPS). LYT-503/IMB-150 was developed using our AlivioTM technology platform (see here), which involves selectively restoring immune homeostasis at inflamed sites in the body while reducing their impact on the rest of the body’s immune system. This long sought-after approach has the potential to broadly enable new medicines to treat a range of chronic and acute inflammatory disorders, including drugs whose use has been limited due to issues of systemic toxicity or problematic pharmacokinetic profiles.

  • Key Points of Innovation & Differentiation
    • To achieve our vision of selective immunomodulation, we are advancing our proprietary Alivio technology platform centered on a class of self-assembling therapies that selectively bind to inflamed tissue. The platform is able to entrap a wide array of active pharmaceutical ingredients (APIs) including small molecules, biologics and nucleic acids. By selectively targeting API pharmacology to inflamed tissue, LYT-503/IMB-150 is designed to selectively treat IC/BPS, minimizing the potential for related systemic toxicities.
  • Program Discovery Process by the PureTech Team
    • A key challenge in new drug development for autoimmune and inflammatory disease is that attractive drug targets are frequently expressed in both diseased and normal tissue. Consequently, we were interested in identifying ways to address autoimmune disease in a targeted manner. We were inspired by a key observation, which is that pathologic inflammation frequently manifests at specific sites in tissues and organs and is driven by dysfunctional immune signaling. However, traditional approaches act broadly to suppress the immune system throughout the body. This mismatch substantially limits the potential targets that can be pursued and frequently results in narrow therapeutic windows. Working with leading scientists, we identified and in-licensed a technology platform in May 2016 that was created by Jeffrey Karp, Ph.D., Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and Robert Langer, Sc.D., David H Koch Institute Professor at MIT. As demonstrated in multiple publications, our Alivio technology platform can be used to develop therapeutic candidates that selectively target inflamed tissues and release drugs in proportion to the severity of inflammation.
  • Patient Need & Market Potential
    • IC/BPS is a chronic bladder condition that consists of discomfort or pain in the bladder or surrounding pelvic region and is often associated with frequent urination. It is estimated to affect four million to 12 million people in the United States. Current treatments fail to control pain in many patients.
  • Milestones Achieved & Development Status
    • In December 2018, we entered into an option and license agreement with Imbrium Therapeutics to advance LYT-503/IMB-150 through clinical development and potential commercialization as a treatment for IC/BPS.
    • In August 2021, we announced that Imbrium Therapeutics had exercised their license option to develop LYT-503/IMB-150. PureTech received an option exercise payment of $6.5 million and is eligible to receive up to $53 million in additional development milestone payments for this program as well as royalties on product sales.
  • Expected Milestones
    • An IND filing for LYT-503/IMB-150 for IC/BPS is planned to be filed in early 2022.
  • Intellectual Property
    • The intellectual property portfolio supporting LYT-503/IMB-150 consists of coverage around both the Alivio technology platform and the drug candidate. Platform intellectual property is supported by two patent families that have been exclusively licensed from the Brigham and Women’s Hospital, which includes three issued patents to date and several pending applications within and outside the U.S. Intellectual property specific to the drug candidate consists one issued U.S. patent along with several U.S. and international patent applications.

Our Alivio technology platform underlying LYT-503/IMB-150 has been described in five peer-reviewed articles published in journals such as Science Translational Medicine and Nature Communications, and has been validated in multiple labs using a range of preclinical models for a range of different indications.