BRIM Biotechnology is developing novel drugs to relieve and repair tissue damage caused by osteoarthritis. BRM521’s unique mechanism of action promotes joint cartilage regeneration and relieves pain.
About Osteoarthritis (OA)
Osteoarthritis (OA), also known as degenerative arthritis, is the most common form of arthritis. OA is caused by excessive use of joints or reduced or abnormal secretion of synovial fluid. This leads to break and worn-out of the cartilage as the cartilage surface becoming thinner and losing elasticity. The continuous friction causes inflammation or abnormal cartilage hyperplasia that eventually produce bone spurs, joint deformation, or complete loss of the cartilage layer. In severe cases, bone fragments may even be produced due to friction between hard bones during joint movement. Therefore, the main symptoms of OA are joint pain, swelling, heat, stiffness, etc., which in turn affect joint activity and even loss of mobility.
3 out of every 4 people over the age of 50 are affected by OA, especially those over the age of 70 with more than 90% are affected. There are slightly more female than male patients. If a joint has been severely injured, it will also increase the chance of OA developing later on. Lack of exercise or excessive exercise will definitely have an impact on joint aging. People who are overweight tend to put greater pressure on their joints, and their chances of developing this disease are 2 to 3 times higher than normal people. In addition, workers who have to squat or bend down frequently will also develop OA earlier. Women often suffer from osteoporosis after menopause, and their bone endurance is even worse, so the disease appears earlier than men.
There is no cure for OA on the market. The current first-line drugs used to treat OA are mainly analgesics. Although these drugs can relieve discomfort, they cannot treat inflammation. Oral or injectable corticosteroids can control inflammation but are not suitable for long-term use. Non-steroidal anti-inflammatory drugs (NSAIDs) can be used long-term, but cause upset stomach and ulcers and may increase the risk of heart attack in some people. Although treatments such as hyaluronic acid or platelet-rich plasma (PRP) are very common and highly accepted, physicians are still skeptical about their true efficacy, especially since most patients feel that the effects are short-lived with limited help. Stem cell therapy has also become more mature in recent years, but there are still problems with the price being too high and the results being inconsistent. Eventually, severely damaged joints will need to consider surgical procedures, such as arthroscopic procedures or even total joint arthroplasty. Although there are many treatment options for OA, there are currently no effective disease-modifying OA drugs (DMOADs) that can inhibit or prevent continued joint degeneration. Therefore, treatments for OA still exist a huge unmet medical need.
Potential first-in-class injectable treatment for Osteoarthritis
BRM521 is a PEDF-derived Short Peptide (PDSP), which is a new drug candidate for osteoarthritis. Its active pharmaceutical ingredient (API) is the same as BRM421, with a different formulation. The final drug product will be an intra-articular injectable, as a first-in-class new drug.
PDSP at joints can induce the proliferation and differentiation of mesenchymal stem cells (MSCs), promoting cartilage regeneration, repairing damaged articular cartilage, and relieving symptoms of pain.
Pre-clinical data
Pre-clinical data indicate that BRM521 has the potential to offer patients a therapeutic advantage over existing treatments. Phase 1 clinical trials for BRM521 are on track to start in 2025.
BRM521：first disease-modifying drug for OA
INDICATION
Osteoarthritis (OA)
MECHANISM
First-in-class, novel regenerative peptide that can activate mesenchymal stem cell proliferation and chondrogenic differentiation
ADVANTAGES
- Activate stem cells for tissue repair
- Early onset and strong safety profile
- Potential disease-modifying to show both structural repair and pain relief
MARKET
- No disease modifying OA drug available
- Global market of USD ~ 8.60 billion in 2023, and projected to be USD ~19.15 billion in 2032
COMPETITION
Pain relief medicines No DMOAD approved drug
DEVELOPMENT STAGE
IND-enabling studies are ongoing
In terms of market share, the current OA market is still dominated by nonsteroidal anti-inflammatory drugs (NSAIDs), followed by steroids and narcotic analgesics. The growth of the main market is driven by the number of patients due to the aging population. Although there are new drugs under development, there is still a long way to go. Most of them are still focusing on pain relief, and there are not many disease-modifying osteoarthritis drugs (DMOADs) as the treatment options. Although cell therapy is expected to be effective in treating OA, it is still with a low market share due to its high price and inconsistent results,. There are still no cell therapy approved for OA in the United States.
BRM521 is a firt-in-class drug with optimized PDSP potential for the treatment of osteoarthritis. The results of animal disease models in rats have confirmed that BRM521 can induce chondrocyte proliferation and chondrogenic differentiation of mesenchymal stem cells (MSCs) to achieve repair of damaged cartilage tissue to relieve pain and reduce inflammation symptoms.
Currently, the U.S. FDA’s primary endpoint requirements for approving OA drugs are to show pain improvement or joint function recovery. In addition, FDA is also actively seeking other appropriate primary endpoints, such as repairment of the structure of bones and joints, etc. Currently, most of the OA drugs being developed are aimed at relieving pain and alleviating symptoms. However, BRM521 aiming to activate the MSCs and chondrocytes has a great potential to specifically treat OA by solving core problems. It has the opportunity to meet the FDA‘s expectations and requirements for new OA drug approval. It also have considerable advantages to be the first disease-modifying OA drugs (DMOADs).
