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/bladder pain syndrome (IC/BPS). LYT-503/IMB-150 was developed using our Alivio™ 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 (PK) 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 allows for the development of inflammation-targeting therapeutic candidates using a wide array of active pharmaceutical ingredients, or APIs, including small molecules, biologics and nucleic acids. Using this technology, LYT-503/IMB-150 is designed to provide local therapy at the inflamed lesions along the bladder surface of IC/BPS patients while 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 such that healthy cells and tissues are not impacted by the drug. We were inspired by the key observation 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 affecting both the disease and healthy tissues. The current approaches therefore substantially limit the potential targets that can be pursued due to 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 U.S. Current treatments fail to control pain in many patients.
  • Milestones Achieved & Development Status
    • In December 2022, the first patient, first visit was completed in the Phase 1 clinical trial evaluating LYT-503/IMB -150 as a potential non-opioid treatment for female patients with Interstitial Cystitis/Bladder Pain Syndrome.
    • 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 its 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 and royalties on potential product sales.
  • 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 one patent family, which has been exclusively licensed from the Brigham and Women’s Hospital and includes seven issued patents and two pending applications within and outside the U.S. Intellectual property specific to the LYT-503/IMB-150 candidate. In addition, the LYT-503/IMB-150 IP includes one patent family which is owned by Alivio that consists of two issued patents and five applications within and outside the U.S.

Our Alivio technology platform underlying LYT-503/IMB-150 is designed to target biologics and other drugs to sites of inflammation in a localized manner while limiting their systemic exposure, which offers the potential to significantly improve both the safety and efficacy profile of the therapy. We believe the targeted activation offered by Alivio offers a path to unlocking the full therapeutic potential of anti-inflammatory drugs in a way that matches the chronic, variable expression of autoimmune diseases. Using this technology, LYT-503/IMB-150 is designed to provide local therapy at the inflamed lesions along the bladder surface of IC/BPS patients while minimizing the potential for related systemic toxicities.