A pooled study using two multicenter, double blind, international, completely randomized, placebo analysis funded by KYTHERA Biopharmaceuticals, Inc.

What is ATX-101

ATX-101 is also called the sodium deoxycholate injection. It is an investigational drug that has the properties necessary to gradually disintegrate or decompose adipocytes which are cells that store fat in the body.

This study is particularly welcome and timely as most people have some level of (SMF) submental fat that they find unattractive. The problem is that there are currently no pharmacological treatment options that are approved by the FDA. The only treatment options that are available are the traditional options such as surgery or liposuction.

Participants in the study

  • To be eligible for the study subjects had to meet the following criteria:
  • Be between the ages of 25-65 years old
  • Must have moderate to severe submental fat (SMF)
  • Had no prior intervention or treatment for submental fat

158 participants enrolled in the study and three of them did not receive the injection and are therefore not included in this analysis. The average weight was 80 kg and the average age of the participants was forty six with over 70% of them female and 98% Caucasian.

The participants in the study randomly received injections of ATX-101 or placebo in weeks four, eight and twelve of the study directly into their SMF. The number of injections to be administered as well as how they were spaced for maximum benefit or effect, was determined by the level or volume of SMF present in the subject. Subjects received between 24 to 48 injections per session using different injection sites each session as much as possible.

Aim of the study

The study sought to investigate the effect of ATX-101 in three main areas

  • The impact on the severity of SMF
  • Skin Laxity
  • As well as how the participants evaluated their own appearance in regards to their face and neck four weeks after their last treatment.
  • It also sought to monitor the subject’s response to the therapy, and any adverse effects, every four weeks over a period of twenty four weeks.

Measurement Tools

The (CR-SMFRS) Clinician Reported Submental Fat Rating Scale was used. The scale measures the presence of SMF using a scale of 0 – 4.

  1. absent no localized Submental fat evident
  2. mild minimal localized submental fat
  3. moderate permanent localized submental fat
  4. severe marked localized submental fat
  5. Extreme extreme submental convexity.

The statistics show that all the groups that received ATX-101 showed a significant reduction in their CR-SMFRS scores up 4 to 12 weeks after the last treatment versus the subjects that received the placebo.

The satisfaction with their appearance scores were significantly higher in those subjects who received the ATX-101 treatment versus those that received the placebo as high as 4.4 versus 3.2.

In regards to skin laxity the study showed that the participants showed no significant difference in their laxity scores even though they had experienced the loss of SMF.

Skin Laxity Scale

  1. No Laxity
  2. Minimal Laxity
  3. Moderate Laxity
  4. Very Lax

Adverse Events were measured ranging from mild, moderate to severe. The most common adverse events reported were:

Numbness

Pain

Swelling

Induration

Bruising

All participants experienced these effects. The major difference between those that received the placebo and those that received the ATX-101 was numbness and induration.The adverse effects reported were mostly mild or moderate and temporary in nature. They disappeared or were resolved before the start of the next due treatment session.There were no systemic adverse events reported.

Follow up study

Participants in the study were invited to be part of a 5 year, long term follow up study to further evaluate the impact of ATX-101. Forty five individuals chose to participate. It examined:

  • Long term Safety
  • Durability of efficacy
  • Participants continued satisfaction with their appearance

Results

  • Twenty seven months after their last treatment more than 90% of the subjects have shown further and continued enhancement.
  • Continued and improved satisfaction with appearance.
  • In the area of satisfaction with their appearance 80% of the responders either sustained their satisfaction scores or further enhanced their satisfaction scores.
  • TX-101 is safe for long term use
  • There were no new adverse events reported in the five year long term study.

Conclusions

The ATX-101 (sodium deoxycholate injection has the ability to offer a new, innovating, less invasive option to reduce (SMF) than other traditional more invasive treatment options such as surgery or liposuction.

  1. It improves the level of satisfaction with your appearance.
  2. No systemic adverse events
  3. The treatment is well tolerated
  4. Results in the first two years show a reduction in total SMF
  5. Improvement in the level of satisfaction with appearance of face and chin
  6. Results can last for up to twenty seven months after the last treatment.
  7. No new adverse effects reported to date, showing the excellent tolerability of the treatment