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Large Joints Feature

Source: Centers for Disease Control (CDC) and Wikimedia Commons

Ampion Trial Results Impressive for Severe Knee OA

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, December 28th, 2017

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Englewood, Colorado-based Ampio Pharmaceuticals, Inc. has announced that the Phase 3 clinical trial of Ampion has met its primary endpoint, with 71% of Ampion treated patients meeting the OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) responder criteria.

According to the company this “…exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis [OA] of the knee.”

“Responders experienced, on average a 53% decrease in pain as measured by WOMAC A [Western Ontario and McMaster Universities Arthritis Index] and a 50% improvement in function as measured by WOMAC C and a 45% improvement in quality of life as measured by patient global assessment (PGA).”

“In the secondary endpoints, Ampion-treated patients achieved statistical significance in a composite endpoint of pain and function from baseline in both categories at 12 weeks, which was supported by an increase in quality of life as measured by patient global assessment (PGA).”

“When treated with Ampion, patients experienced significant improvement in a composite endpoint of pain and function compared to all KL 4 saline-treated patients in Ampion phase 3 clinical trials.”

Ampion is a non-steroidal, anti-inflammatory, “low molecular weight fraction of human serum albumin (HSA)…. The primary constituent ingredient of Ampion is aspartyl-alanyl diketopiperazine, or DA-DKP, an endogenous immunomodulatory molecule derived from the N-terminus of HSA.”

“Based on published pre-clinical and clinical research, DA-DKP plays a significant role in the regulation of inflammation. DA-DKP is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T-cells.”

“Ampion also contains other known small molecules that confer anti-inflammatory effects to complement the activity of DA-DKP and derive demonstrated in-vitro and in-vivo effects.”

“Ampio is currently developing Ampion as an intra-articular injection to treat osteoarthritis of the knee….”

David Bar-Or, M.D. is chief scientific officer and director at Ampio. He told OTW, “What excites me is the potential we have here, based on the science and the mechanism of action, for a disease-modifying drug. I have strong evidence that we can rebuild cartilage in the knee.”

“The primary endpoint itself is probably the most interesting piece of the study. As Ampio believes it to be more inclusive and representative of the general population. Additionally, Ampio only used KL4 patients, the most severe grade for this trial. The OMERACT-OARSI response composite looks to assess three core symptoms of [osteoarthritis of the knee] OAK (pain, function, and patient's global assessment) as a single variable. For each domain, a response requires both a relative and an absolute change.”

“The most important results were that these results were achieved in a very difficult to treat patient population that has limited options. Ampion is in development to address the signs and symptoms for the unmet medical need of severe osteoarthritis of the knee and provide orthopedic surgeons and rheumatologists a new and safe option to offer to these patients. Ampion has a robust safety profile and a meaningful response in this chronic, progressive condition. The science indicates that there is a potential for this treatment not only to relieve the signs and symptoms of OAK, but also have a healing effect and affect positively cartilage regeneration.”

“When approved this will be a safe and effective solution to this condition which may delay or avoid total knee arthroplasty. The science behind Ampion is novel and well understood and has been published in peer-reviewed journals and Ampio is expected to publish additional data from this trial in the future as well.”

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Comments

3 Responses to “Ampion Trial Results Impressive for Severe Knee OA”

  1. Dov safir says:

    I have been part of the ampion trial the 3 single injection trial. The Mayo Clinic in Scottsdale Arizona told me after my last knee scope in 2012 that I would need a knee replacement in the near future . I had arthroscopic surgery and the surgeon said that there’s nothing else to shave or improve in the knee it would need to be a knee replacement. After getting Ampion my pain totally went away I hike 3 to 4 times a week now and I play tennis physical activities that we’re not possible before receiving Ampion. The quality of my life has improved tremendously my blood pressure improved my cholesterol has improved overall this is a miracle drug .

  2. Jeff Modesitt says:

    Thanks for the realistic assessment of Ampion. Up to this point, the only non-company assessments have been generated by financial types (newsletter writers and dark pool traders/algotraders) who seem to want to put the company out of business.

  3. Bill says:

    While it’s good to have another statement from Bar Or in addition to the latest announcement, providing data for claims of regeneration in the clinic seem remote. They have already published in vitro data showing “potential” to “affect positively” cartilage regeneration.

    But, when they actually tested (by MRI) for cartilage growth after 3 injections of Ampion (spaced 2 wks apart) they found no significant changes. That was the STRUT trial (52 wks).

    Sprifermin and SM04690 have actually proved cartilage healing by MRI with similar time frames. No trial has shown measurable healing within 12 wks, which was the timepoint in the last Ampion trial. So, the source of any new data that Bar Or has for proven (statistically significant) *clinical* (not laboratory) improvement seems questionable.

    Still, showing that Ampion has an effect beyond saline using the combined pain+function metric for KL4 patients instead of the usual WOMAC A pain scale should be enough to support BLA filing.

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