Alkem, in collaboration with Stempeutics, launches 'StemOne' to treat Knee Osteoarthritis

Mumbai, September 19, 2022

Pharmaceutical company Alkem Laboratories has announced that regulatory approval had been received from the Drug Controller General of India (DCGI) for the launch in India of StemOne, indicated for the treatment of Knee Osteoarthritis (OA).

It is the first allogeneic cell therapy product to be approved for commercial use in India for Knee OA, a press release from the company said here today.

The release said the product had been developed by Stempeutics, a group company of Manipal Education and Medical Group, over a period of twelve years.

"The company’s proprietary technology platform provides for an efficient manufacturing process thereby enabling the product to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients," it said.

Knee OA is one of the most common debilitating diseases experienced within an ageing population and constitutes an urgent medical need. Also, obesity, a major risk factor, is increasing in prevalence leading to increased occurrence of osteoarthritis. The estimated OA population in India alone is approximately 35 million. Presently, treatment options available include NSAIDs, glucosamine and chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections, steroid injections, PRP injection and, ultimately, total knee replacement.

No disease modifying drug options are yet available for this condition, the release said.

The treatment comprises of a single intra-articular injection of StemOne in an outpatient procedure with no anaesthesia requirement, it said.

"Existing treatment options focus on providing temporary pain relief and reducing inflammation during the early stages of the disease without affecting the course of the disease. StemOne has the potential to provide best-in-class pain reduction, improve quality of life, has the potential to maintain cartilage quality and to stall further disease progression in Grade 2 & Grade 3 Osteoarthritis patients. StemOne has anti-inflammatory & immunosuppressive properties which reduce inflammation in the knee joint. StemOne may initiate the repair process by differentiating into chondrocytes or by inducing proliferation and differentiation of endogenous chondro-progenitors into mature chondrocytes or both," the release said.

Sunil Pathak, Senior Vice President & Cluster Head at Alkem, said, “Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs and alleviate suffering. Knee OA is a serious and painful condition that impacts patients worldwide and we are happy that we are able to introduce this stem cell therapy in the country at an affordable cost. Current Knee OA treatments are more symptomatic in nature whereas StemOne drug has potential to address the root cause of the disease. StemOne offers a novel treatment approach to the physicians in India to treat Knee OA and will substantially improve the quality of life of millions of patients suffering from this painful disease."

Commenting on the DCGI approval, Manohar B N, MD & CEO of Stempeutics, said, “Obtaining DCGI approval for StemOne is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our global leadership in allogeneic, pooled MSC technology. We believe that the StemOne product is a game-changer, offering an advanced therapeutic treatment for millions of patients suffering from this painful disease.”

The release said clinical trials held in India had demonstrated significant improvement in pain relief and physical functions, as well indicators towards decreased progression of OA and improvements in joint structure

Pawan Gupta, Sr. Vice President, Medical & Regulatory Affairs, Stempeutics, said, “StemOne product is developed from Bone Marrow Derived, Cultured Pooled, Allogeneic Mesenchymal Stromal Cells. Our Phase III trial is a double blind, randomised, placebo-controlled trial. We have administered StemOne using ultrasound guidance and used new MRI techniques called T2 mapping to assess the quality of articular cartilage. We are extremely happy to see statistically significant data on our primary end point i.e., the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm. Also, statistical significance was observed in WOMAC OA Pain Index/ Stiffness Index / Physical function Index”.

According to the release, the allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery or delay the progression of OA to minimize the need for multiple surgical interventions.

"This is a new hope to thousands of patients who would otherwise have to undergo knee replacement surgery sooner or later. India sees on an average 200,000 knee transplant surgeries each year, with an estimated cost burden of Rs 4000 crore," it said.

Alkem will market and distribute the novel drug in India for patient access, the release added.

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