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Jerusalem, Israel, August 14 2018 – Immunity Pharma, a clinical-stage neurology-focused biopharmaceutical company, announced today the initiation of a Phase 1/2a clinical trial of IPL344 in patients with amyotrophic lateral sclerosis (ALS) The trial is held at the ALS unit of the Hadassah Medical Center in Jerusalem, and its principal investigator is Dr. Marc Gotkine, a leading and reputable expert in the field of ALS.

The Phase 1/2a trial is an open-label, dose-escalation clinical trial, to assess the safety and tolerability of daily treatment of IPL344 for 1 month in patients with ALS. This study will be immediately followed by a Phase 2a clinical trial with long-term administration of once-daily IPL344 to the same patients in order to assess long-term safety, tolerability and efficacy. Key objectives of the trial include slowing disease progression according to respiration, muscle strength and ALS functional scores. The first report of the trial’s outcomes is expected in mid-2019.

IPL344 has been previously successfully administered as a long-term compassionate treatment for a single ALS patient, whose disease rapidly deteriorated before start of treatment. For more than 2 years, while on IPL344 treatment, this patient’s disease progression has significantly slowed down and condition was largely stabilized.

“The study is designed and backed by top experts in the field” said Dr. Ilana Cohen, Immunity Pharma's VP, Research and Development, “An important feature of this Phase 1/2a trial is that it employs an array of clinical and biologic assessment methods to collect as much information as possible towards the more advanced phase clinical trials of IPL344 in ALS. Based on cell culture, animal model studies and a previous compassionate treatment with IPL344, we believe that IPL344 may have a long term positive effect on ALS patients,”

"IPL344 employs a novel approach to activating a key therapeutic pathway in ALS. We believe that success in the current trial will lead to a larger phase 2b which could be the basis for a conditional regulatory approval of the drug for the benefit of ALS patients, who today have very limited treatment options.  As IPL344 targets a molecular process that is common to several other neurodegenerative diseases as well, we believe that success in this trial will pave the way to treatment of other neurodegenerative diseases that share a biological background similar to ALS." said Eran Ovadia, Immunity Pharma's founder and CEO.

“Our goal is to help ALS patients control their disease for prolonged period of time and contribute to the treatment of other neurodegenerative diseases as well. There is a significant unmet medical need for effective drugs to treat neurodegenerative diseases in general, and ALS in particular,” said Ron Pfeifer, Immunity Pharma’s chairman of the board. “We believe in the innovative scientific basis of our technology and in its high business potential”

Efrat Carmi, the CEO of IsrALS, the Israeli-based ALS patient advocacy association, said “This ALS endeavor started with the assistance of our scientific grants, we are proud to be part of this effort that has the potential to stabilize the condition of ALS patients.”

About IPL344

IPL344 is Immunity Pharma’s lead drug candidate. IPL344 was discovered in the Weizmann institute of Science, Israel, at Prof. Irun Cohen's Laboratory. IPL344 is being developed as an intravenous injection for the treatment of ALS and is currently in a Phase 1/2a clinical trial in ALS patients. IPL344 activates the PI3K-Akt signaling pathway in a variety of cells, including neurons, inducing pro-survival and anti-inflammatory processes.

About Immunity Pharma

Immunity Pharma Ltd. (IPL) is a privately-held clinical-stage neurology-focused biopharmaceutical company that develops therapies for neurodegenerative diseases, with an initial focus on Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. IPL’s drugs are biologically active peptides that stimulate therapeutic cell-signaling processes which are down-regulated in neurodegenerative diseases. These drugs mitigate progression of neurodegenerative diseases by inducing survival-supporting processes, including reduction of inflammation and reduction of programed cell death (apoptosis).

For more information please visit www.immunitypharma.com