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  • Phase III AP-003-C trial of Ampion shows efficacy ...

Phase III AP-003-C trial of Ampion shows efficacy out to 12 weeks in osteoarthritis of the knee.- Ampio Pharma

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Published:18th Jun 2021
Ampio Pharmaceuticals reported newly integrated data from four of its earlier clinical trials with consistent inclusion, exclusion, and demographic populations utilizing Ampion (aspartyl-alanyl diketopiperazine) for treating osteoarthritis of the knee (OAK).

Data from these 585 patients categorized as severe (i.e., Kellgren-Lawrence grade 4, or KL 4) demonstrates Ampion's consistent and statistically significant clinical effect in the reduction of pain compared to saline at two, ten, and twelve-week intervals subsequent to intra-articular injection.

The results integrate data from severe OAK patients who were enrolled in Ampio's AP-003-C Phase III clinical trial with the previously published results. The pooled data show an even greater statistical significance, with a reduction in pain of 34.3% at two weeks (compared to 28.6% for saline, p value 0.041), 38.1% at ten weeks (30.4% for saline, p value 0.006) and 36% at twelve weeks (25.7% for saline, p value <0.001). ampion has proven safe in thousands of enrolled and randomized patients, supporting repeat administration. no drug-related serious adverse events (saes) or treatment-related deaths have occurred, and the majority of adverse events (aes) were unrelated to treatment. the incidence and severity of adverse events are similar for ampion and saline, and the incidence of related aes is far lower than that reported for existing therapies.></0.001).>

Top-line results from Ampio's AP-003-A, AP-003-B, and AP-004 trials were previously published in Orthopedics (Orthopedics. 2018; 41(1):e77-e83), which reflected a clinically and statistically significant reduction in pain at weeks ten and twelve following a single injection, compared to saline, using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. In addition, Ampion showed a 35.6% and 33.2% reduction in pain at weeks ten and twelve compared to baseline, while saline showed a reduction of 29% and 24.7%, with a p value of 0.04 and 0.012 comparing the two, respectively.

Condition: Pain:Osteoarthritis/ Knee
Type: drug

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