Grant Award Details

Evaluation of the Safety and Tolerability of KA34 in a Phase 1, Double-Blind, Dose Escalation Trial in Patients with Knee Osteoarthritis
Grant Number: 
CLIN2-10388
Project Objective: 

  • Evaluation of the Safety and Tolerability of KA34 in a Phase 1, Double-Blind, Dose Escalation Trial in Patients with Knee Osteoarthritis
Investigator: 
Institution: 
Type: 
PI
Disease Focus: 
Arthritis
Bone or Cartilage Disease
Osteoarthritis
Human Stem Cell Use: 
Adult Stem Cell
Award Value: 
$8,447,523
Status: 
Active

Grant Application Details

Application Title: 
  • Evaluation of the Safety and Tolerability of KA34 in a Phase 1, Double-Blind, Dose Escalation Trial in Patients with Knee Osteoarthritis
Public Abstract: 

Therapeutic Candidate or Device

KA34 is an intra-articularly delivered small molecule therapeutic candidate which directs the differentiation of endogenous stem and progenitor cells

Indication

Osteoarthritis

Therapeutic Mechanism

KA34 promotes the differentiation of cartilage endogenous stem cells through increased chondrogenic gene expression to generate healthy chondrocytes. KA34 will potentially limit the progression of and / or reverse the osteoarthritis disease process. KA34 may generate new cartilage matrix within the pre-existing matrix without fibrotic cartilage formation and aims to improve the clinical joint scores.

Unmet Medical Need

There are no approved disease-modifying therapies available which stop the joint damage in 30 million osteoarthritis patients in the United States. This grant will support execution of a Phase 1 clinical trial to evaluate the safety of the small molecule, KA34, which stimulates cartilage repair.

Project Objective

Completion of a Phase I clinical trial for KA34

Major Proposed Activities

  • Completion of clinical site selection, start-up activities and execution of the Phase I single and multiple ascending dose clinical study with KA34
  • Data analysis and reporting on the Phase I single and multiple ascending dose clinical study with KA34 in osteoarthritis patients
  • Evaluation of potential KA34 treatment-associated biomarkers to support future clinical development of KA34 in osteoarthritis
Statement of Benefit to California: 

Almost six million adults in California are affected with arthritis, with osteoarthritis being the most common manifestation of this disease. For the average patient, ~$129,600 of direct medical costs are incurred in their lifetime and 50% need a total joint replacement, an invasive surgical procedure. KA34 was developed for delivery by a local injection to the affected joint. It aims to limit the progression of OA which may reduce medical costs and burden to the primary care givers.