The Science Behind MOTYS™

A Phase 3-ready biologic therapeutic derived from placental tissue, delivering unparalleled efficacy in osteoarthritis treatment through a triple-action mechanism of action.

MOTYS

Phase 3 Asset

Derived from placental tissues, MOTYS™ is a biologic therapeutic classified as a Regenerative Medicine Advanced Therapy (RMAT). Effects from a single intra-articular injection of MOTYS™ last 9-12 months—no other treatment is this potent.

MOTYS™ holds great potential as a biologic therapy, because it displays a multifactorial mechanism of action (MOA). This MOA promotes a beneficial combination of anti-inflammatory, anti-catabolic and pro-anabolic effects, demonstrated through in vitro and in vivo data in a range of applications.

Pro-anabolic

Pro-anabolic

New tissue formation through cell recruitment, differentiation, and/or proliferation

Anti-catabolic

Anti-catabolic

Mitigation of cartilage degeneration

Anti-inflammatory

Anti-inflammatory

Reduction of pain and swelling

The Source

Harnessing the Power of the Placental Secrotome

Placental tissue sourcing

Ethically Sourced

Immunologically inert placental tissue sourced from rigorously screened donations after planned, healthy C-section births

Proprietary processing

Proprietary Processing

Proprietary process conserves and concentrates the stem cell secrotome. Consistently rich in extracellular matrix, growth factors, and signaling molecules

Final formulation

Consistent Formulation

Cell free, terminally sterilized, refrigerator stable formulation. Rigorous and proprietary controls ensure consistent, reproducible potency of final formulation

Remarkable Potential


MOTYS™ was developed with a goal of providing a more consistent amniotic option. Through careful recovery, specialized processing and testing, MOTYS™ has demonstrated lot-to-lot consistency of naturally occurring biofactors.

Sterile
Containing no live cells
Refrigerator Stable
Stored at room temperature
Easy to Reconstitute
Simple preparation process
9-12 Month Duration
Long-lasting single injection
Preclinical Data

Proven Superior to HAs and Steroids

In preclinical head-to-head comparisons, MOTYS™ was proven superior to hyaluronic acids and steroids in pain relief, cartilage protection, and duration of effect.

Effect on Pain and Cartilage Protection: Potential for Disease Modification

In a rat OA model, MOTYS™ provided superior and more durable pain relief compared to HA or steroid. MOTYS™ also provided superior effects on scores of cartilage protection.

Preclinical cartilage data

Remarkably Consistent, Disease Relevant Biofactors

>300 regulatory proteins detected in MOTYS™ contribute to its biologic mechanism of action

IL-1Ra

Anti-inflammatory

Reduction of pain and swelling

TIMP-3

Anti-catabolic

Mitigation of cartilage degeneration

bFGF

Pro-anabolic

New tissue formation through cell recruitment, differentiation, and/or proliferation

Clinical Data

Unparalleled, Durable Improvements in Pain and Function

A single MOTYS™ injection provides remarkable, lasting benefits. Our large clinical database (n>350) provides clear direction for successful Phase 3 clinical study execution.

IND Phase 1 Safety Study

n=20; 12-month follow up
  • No safety findings, no immunological reactions
  • Potent and durable effect on symptom relief reported up to 12 months

Open-label RWE Study

n=140; 12-month follow up
  • After 12 months, 70% of patients still experience benefits from a single injection of MOTYS™

Phase 2b RCT

n=215; 6-month follow up, placebo controlled
  • 70% improvement on pain and mobility scores at 6 months
  • Informed the design of a risk mitigated Phase 3 study

Phase 3 Trial 1

n=260; 6-month follow up, placebo controlled
350+

Patients Treated

Extensive clinical experience across multiple studies

70%

Response Rate

Patients experiencing benefits at 12 months from a single injection

Excellent Safety Profile

No safety findings or immunological reactions observed

Phase 3 Asset

De-risked program currently in Phase 3 clinical trial

Pipeline

Beyond Knee Osteoarthritis

While our primary focus is advancing MOTYS™ through Phase 3 trials for knee osteoarthritis, the therapeutic potential extends to other joint indications and musculoskeletal conditions.

Future Indications Under Exploration

The multifactorial mechanism of action of MOTYS™ suggests potential applications in:

Hip Osteoarthritis

Leveraging the same anti-inflammatory, anti-catabolic, and pro-anabolic properties

Shoulder Osteoarthritis

Expanding to other major weight-bearing joints

Tendinopathy

Addressing chronic tendon degeneration and inflammation

Other Degenerative Conditions

Exploring opportunities for tissue regeneration

Phase 3 Focus

Our current focus remains on successfully completing Phase 3 development for knee osteoarthritis, establishing MOTYS™ as a gold-standard therapy before expanding to additional indications.

For Physicians

Doron Therapeutics Expanded Access Policy for PTP-001 (MOTYS)

Doron Therapeutics' goal, whenever possible, is to encourage patients to participate in our clinical trials. Clinical trials determine how well an investigational therapy, like PTP-001, works as compared to the existing standard of care or a placebo, and whether the potential therapy is safe and effective. Clinical trials also explore whether the benefits of the investigational therapy outweigh the risks and provide the safest opportunity for people to access an investigational therapy before it is approved by a regulatory agency.


Under Section 561A(f)(2) of the US Federal Food, Drug, and Cosmetic Act (FDCA) Doron is also required to make its Expanded Access Policy for PTP-001 publicly available. At this point in time, PTP-001 is not available for Expanded Access Use. Doron Therapeutics will re-evaluate its Expanded Access Policy on a periodic basis and make any updates publicly available.


If Doron Therapeutics decides to make PTP-001 available for Expanded Access Use, we will evaluate and respond to each request that we receive from a patient's treating physician on a case-by-case basis. Questions about Doron's Expanded Access Policy should be made by email to regulatory@dorontherapeutics.com.

Learn More About MOTYS™

Our team can help to answer any of your questions about the science and clinical development.

Contact Us About Doron Therapeutics