Osteoarthritis of the Knee

Osteoarthritis (OA) is one of the most common debilitating diseases experienced within an ageing population and constitutes an urgent medical need. Obesity, a major risk factor, is further increasing prevalence and occurrence of OA. Approximately 30% of the global population over 60 years of age, suffers from OA and have no disease modifying treatment options. OA largely affects weight bearing joints such as the knee joint & hip joint amongst others. Existing treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Hyaluronic Acid injections (HA), Diacerin (IL-1 inhibitor), or steroid injections. All of these treatments focus on providing temporary pain relief and reducing inflammation during early stages of disease without affecting the course of the disease. All patients ultimately, if able to undergo surgery, will require total knee replacement.

Our in-licensing partner has developed and obtained marketing authorization Stem-One Cell Drug Product for treatment of Grade 2&3 Knee OA patients in India. Results from randomized, blinded, placebo-controlled trials with single injection of Stempeucel-OA [CTRI/2018/09/015785 (National Institutes of Health and Clinical Trials Registry-India)] demonstrated statistically significant reduction in pain, and improvement in function; (Ref: Am J Sports Med. 2023 Jul;51(9):2254-2266); with robust quality & thickness of cartilage tissue demonstrating halt in further disease progression, even at 2 years post-treatment.

Our lead indication is Osteoarthritis of the knee. We intend to develop additional products using the pooling technology and enhancements to it for several additional indications including for example Chronic Limb Ischemia, Diabetic Foot Ulcers, and Degenerative Disc Disease.

American College of Rheumatology/Arthritis Foundation Guideline - 2019


Recommended
Strongly Recommended

Weight Loss
Exercise: Tai-chi, swimming etc. TF Knee Brace
Oral and topical NSAIDs
Intra articular steroids
Conditionally Recommended

Other painkillers: Acetaminophen, Tramadol
Topical Capsaicin
Oral and topical NSAIDs
Intra articular steroids
Not recommended
Strongly Against

Bisphosphonates, Glucosamine
Biologics: TNF Inhibitors, IL-1 Antagonist
PRP
Intra articular steroids
Conditionally Against

Intra-articular Hyaluronic Acid
Non-Tramadol Opioids
Oral and topical NSAIDs
Intra articular steroids

At least initially, Physicians are likely to use Stempeucel after IA steroid failure; Extensive real-world data could broaden use
Physician view of Stempeucel's place in the line of treatment
1

IA-HA failure

Potentially high price and co-insurance payments was the primary reason
Initially Physicians are likely to try Stempeucel in few patients and form their own opinion
"You are going to charge a bomb for this. This will likely limit its use to IA-HA failure patients"
2

IA steroid failure

Existing guidelines focus on IA steroids
Quickness of action of steroids makes them preferred product right now
Potential payer pressure to step through
"I would use product x after IA steroids. I would not immediately start using it in naïve patients"
3

IA steroid failure

Potentially disease modifying action
Would need extensive real-world data
Longer term data 2-3 years will benefit immensely
"You know what, this is a potentially disease modifying treatment. With long term efficacy data, I might try it in IA naïve patients"

Physicians generally follow treatment guidelines; though significant inter-practice variations exist regarding IA drug choice
Physician prescription behavior

Based on US Physician and Payer feedback, 40% of IA steroids/ HA injection failure patients will likely use Stempeucel
Based on US Physician and Payer feedback, 40% of IA steroids/ HA injection failure patients will likely use Stempeucel
Base case
Use case in IA treatment naïve patients
Summary of Stempeucel Product Clinical Data

Stempeucel® is approved by CDSCO (Indian FDA equivalent) for treatment of (1) Grade 2 & 3 Osteoarthritis of the knee in non-obese patients with BMI 30Kg m² (2) No-option CLI due to Bruegers Disease & Artherosclerotic Peripheral Arterial Disease