CliniExperts Conducted Successful Study for ALFLUTOP® in Indian Patients

Biotherapeutics, a fastest growing sector has witnessed an incredible growth spread in to the areas of genetic disorder, regenerative therapy, and personalized medicine.
A good starting point for any drug or a biotherapeutic is thorough data generation. CliniExperts designed the study which aimed to generate data and provide valuable insights into how Alflutop performs in Indian population.

ALFLUTOP® solution for injections (Biotehnos SA, Romania), thus emerges as a safe, tolerable and beneficial long term treatment option for subjects with Osteoarthritis.

- CliniExperts Research Services Pvt. Ltd.

August 30, 2024

Key aspects of the Product used to design the Study

Alflutop®, is a biotherapeutic product that is a natural chondroprotective product with anti-inflammatory effects, contributing to regeneration at the cartilage level. During its 27 years of market experience, the safety profile of Alflutop® has remained consistent and stable.

An impressive number of patients, approximately 2,33,67,534, which translates to 4,67,35,069 packs of Alflutop®, have benefited. Regulatory authorities in the countries where Alflutop® is authorized have not reported serious or severe ADR for the medicine.

Despite its extensive use in various countries, the efficacy and safety of Alflutop® have not been fully established in the Indian population. Biotherapeutics, a fastest-growing sector has witnessed incredible growth spread into the areas of genetic disorders, regenerative therapy, and personalized medicine.

A good starting point for any drug or biotherapeutic is thorough data generation. CliniExperts designed the study which aimed to generate data and provide valuable insights into how Alflutop® performs in Indian population.

The study designed investigated the efficacy, safety and tolerability of Alflutop®, solution for injection, administered intramuscularly in men and women aged 40 to 75 years subjects with osteoarthritis of knee joints. This was 8 week, prospective randomized, double-blind, multicentric, phase III trial, conducted at 07 sites in India.

Participants were randomized to either Alflutop® or standard of care treatment for a duration of 20 days with the entire study participation extending to 56 days, plus an additional 2 days. The study was structured into 4 distinct visits and study related procedures.

27 years product’s market experience – Consistent and stable safety profile
No ADR complaints raised by regulatory authority- product’s reliability and patient tolerance
Potential Indian Market Entry
Boosted patient’s quality of life and overall well-being.
Excellent Efficacy as a chondroprotector
Impeccable safety on a long run

Outcomes

The primary endpoint was to evaluate the percentage change in WOMAC scores which is a systematic way to measure the impact of osteoarthritis (greater pain, stiffness, and functional impairments) on a patient’s quality of life and overall well-being.

Among the 218 evaluable subjects, there was significant reduction in WOMAC pain score for Alflutop® by 29.4 % at Week 4 & while for the SOC arm it was only by 11.9% and at Week 8 reduction in WOMAC pain Score for Alflutop® was by 45.7% & by 33.2% in the SOC arm.

The difference was statistically significant (p-value <0.0001), indicating an earlier and greater improvement with Alflutop® with standard of care treatment (Table 1, Figure 1).

	Alflutop® + SOC		SOC
	At 4^th week (%)	At 8^th week (%)	At 4^th Week (%)	At 8^th week (%)
WOMAC SCORE	29.4	45.7	11.9	33
OMERACT-OARS	89.9	91.7	74.	84
EQ-5D	44.5	80.3	34.2	75.5
IGA	22.7	44.5	12.6	31.2
PGHQ	22.8	44.7	15.2	35.1

Table 1: Comparison of mean percentage change in the Scores at the end of 4^th week and 8^Th Week in the two groups

Quality of life Profile with Alflutop®+SOC was evaluated with OMERACT-OARSI scale, EQ-5D, Investigator global assessment (IGA), Patient global health questionnaires (PGHQ) and 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The mean percentage changes for all questionnaires were observed at 4th week and 8th week. There was overall significant and consistent improvement in all measures of quality of life with Alflutop®+SOC seen as early as 4 weeks due to the reduced disease severity which helped patients to have better quality of life (Figure 2).

Among the 218 evaluable subjects, a total of 65 adverse events were reported in 47 subjects and all of them were classified as mild whereas 34 were classified as mild not related to the study drug. Crucially, no serious adverse events were reported during the course of the study underlining the overall safety profile of the treatment.

Trial summary

This phase 3 study involving males and females with osteoarthritis of knee joints were administered Alflutop®, a biotherapeutic, intramuscularly.

These findings underscore the potential of Alflutop® in effectively managing the condition and improving the well-being of patients.

The results strongly suggests that the Alflutop® has is a chondroprotector, prevents the destruction of macromolecular structures of normal tissues, stimulates the regeneration processes in interstitial tissue and articular cartilage tissue, which explains its therapeutic efficiency in knee osteoarthritis in terms of reductions in clinical signs of inflammation and mobility.

Importantly, the safety profile of the Alflutop® therapy is comparable to that of the standard of care treatment used currently.

CliniExperts choose the primary & secondary endpoints, the scales, questionnaires and designed the study to generate data of sufficient validity and generalizability of the product – Alflutop® in Indian patients and successfully achieved results with statistically significant differences.