Anti-COPD Therapy, Anti-OA Therapy, Anti-DED Therapy
HaplnScience is currently developing rhHAPLN1 (recombinant human Hyaluronic Acid and Proteoglycan Link Protein) preparations and planning a global clinical development under the partnership with pharmaceutical companies. HAPLN1 plays a key role in structuring hyaluronan-proteoglycan aggregate as a link protein and modulates CD44, TGFβ signaling and hyaluronic acid. Through the above-mentioned modulating actions, it has tissue regeneration effect, anti-senescent effect, and anti-inflammatory effect, anti-oxidation effect as well as moisturizing effect. These multi-functional activities are useful for the treatment of aging-related diseases such as COPD, IPF, DED, OA, skin aging, and alopecia.
1) Anti-COPD, Anti-IPF Therapies (HS-401/402)
HS-401 (rhHAPLN1 for inhalation) is a preclinical asset believed to be a first-in-class disease-modifying drug for COPD by regenerating the functions of degraded alveoli in COPD patients. With the aging population and environmental factors, the number of COPD patients is increasing but, at present, there are only drugs for symptomatic relief with no fundamental therapies available. COPD is a chronic obstructive pulmonary disease with continuous respiratory failure accompanying chronic bronchitis, emphysema or asthma. In people with emphysema, the alveoli are damaged and the inner walls of the alveoli are weakened and ruptured in part due to degraded elastic fibers. This creates larger air spaces, instead of many small ones, which are less effective in gaseous exchange and leads to respiratory failure. We are investigating whether we can regenerate alveolar tissue by administering rhHAPLN1. A preliminary efficacy study in mice has shown 97% recovery of MLI (Mean Linear Intercept) vs. normal, suggesting rhHAPLN1 may have potential as a disease modifying agent. Furthermore, some antifibrotic efficacy has been observed in bleomycin IPF model implicating its role in balancing the homeostasis in ECM. It is currently under DP formulation study as a nebulizer and preclinical studies are currently undergoing and is planned to file an IND for FIH study in early 2023.
HS-402 is a preclinical asset believed to become the very innovative treatment for IPF through the inhalation of rhHAPLN1, acting as disease modifying drugs. While carrying out a non-clinical study of HS-401 which provided us distinct recovery of MLI (Mean Linear Intercept) and anti-inflammatory effect in an efficacy study in mice, we obtained evidence that rhHAPLN1 has good anti-fibrotic effect. Hence, by carrying out separate studies with rhHAPLN1 targeting IPF (now named HS-402), it showed strong antifibrotic efficacy in bleomycin-induced IPF model, proving its role in strengthening the homeostasis in ECM. Combining these results, we believe that rhHAPLN1 can be applied to treating CPFE (Combined Pulmonary Fibrosis and Emphysema), shown at 30% of IPF patients with both features of COPD & IPF. For CPFE, there has been no SoC so far, as patients usually get the treatment upon their symptoms. Since stresses on lungs provoke the pathogenesis by promoting disease progression such as COPD or IPF, the drug (HS-401/402) may inhibit the disease progression at the first place of pathogenesis initiation and treat/manage the symptoms of both diseases. It could become the blockbuster drug covering both diseases, especially, CPFE market. Based on the confirmed data from non-clinical studies, we believe HS-402 can become a solution to the treatment of CPFE and IPF
2) Anti-OA Therapy (HS-101)
HS-101 (rhHAPLN1 for intra-articular injection) is an IND-enabling stage preclinical asset targeted at osteoarthritis, which is known to be one of the most common degenerative diseases associated with aging. It is estimated that there are more than 300 million patients suffering with OA, but at present, there are no DMOAD available. Interestingly, it has been reported that the level of HAPLN1 is significantly reduced in OA cartilage cells vs. normal and w