Ouro Medicines Takes Bold Step with OM336

Ouro Medicines Takes Bold Step with OM336

By, Admin 6 August 2025

Biotech startup Ouro Medicines has launched a multi-national clinical trial for OM336, a bispecific T cell engager antibody aimed at treating two severe autoimmune diseases:

  • Autoimmune Hemolytic Anemia (AIHA)
  • Immune Thrombocytopenia (ITP)

In a significant milestone, the FDA granted Orphan Drug Designation (ODD) to OM336 for treating AIHA.

What Makes OM336 Different?

The Problem with Current Treatments

Patients with AIHA or ITP often face:

  • Long-term immunosuppression
  • Side effects that reduce quality of life
  • No promise of lasting remission

OM336 offers a potential "immune reset", a chance to induce durable remission without ongoing suppression of the immune system.

How OM336 Works

OM336 is a BCMAxCD3 bispecific antibody that targets and destroys B-cell populations behind autoimmune attacks.

Key features:

  • Detuned CD3 arm: Reduces risk of severe immune activation
  • Long half-life: Allows for subcutaneous dosing
  • Potent but controlled: Maintains efficacy with better tolerability

More than 80 patients have already been dosed with OM336 across multiple trials, including:

  • Autoimmune Bullous Diseases
  • Multiple Myeloma
  • Relapsed/Refractory AIHA
  • ITP

Positive results from case studies published in NEJM showed:

  • Normalization of lab values within a month
  • Patients remained in remission without further treatment for six months or longer

About the Clinical Trial

Trial Design and Objectives

  • Study Phase: Phase 1b
  • Geography: USA and Australia
  • Participants: Adults with active AIHA and/or ITP
  • Dosing: Subcutaneous, ascending dose cohorts
  • Primary Endpoint: Safety and tolerability at Week 12
  • Exploratory Goals: Efficacy and biomarker tracking

What Does FDA Orphan Drug Designation Mean?

For OM336, this status brings:

  • Tax credits
  • Waived FDA fees
  • 7 years of market exclusivity, if approved
  • Runs alongside 12-year reference product exclusivity

Understanding the Diseases

Autoimmune Cytopenias 101

These are autoimmune diseases where the body attacks its own blood cells.

AIHA:

  • Destroys red blood cells
  • Causes fatigue, shortness of breath, dizziness, and risk of blood clots

ITP:

  • Targets platelets
  • Results in low platelet counts, bruising, and dangerous bleeding episodes

Both conditions can be  and lack safe, long-term treatments.

About Ouro Medicines

Ouro is a San Francisco-based biotech startup founded in 2025. It’s focused on immune reset therapies using T cell engagers.

Backed by:

  • Monograph Capital
  • GSK
  • TPG, NEA, and Norwest

Mission:

To build a new generation of autoimmune therapies that deliver long-lasting remissions without constant immune suppression.

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