Press Release Details


Arena Pharmaceuticals to Present Phase 1 and Preclinical Data on APD371 in Development for Treatment of Pain Associated with Crohn's Disease at American Pain Society Annual Scientific Summit

March 1, 2018 at 8:30 AM EST
- Data from Phase 1 study of APD371 in healthy volunteers demonstrate safety and tolerability
- Healthy volunteers did not exhibit psychotropic effects commonly seen with cannabinoids
- Preclinical studies show thousand-fold selectivity for CB2 over CB1 receptors

SAN DIEGO, March 1, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), will present Phase 1 and preclinical data for the investigative drug candidate APD371 at the American Pain Society (APS) Annual Scientific Meeting on March 6.

These data support the unique profile of APD371, a peripherally restricted, highly–selective, full agonist of the cannabinoid 2 (CB2) receptor. APD371 was evaluated in Phase 1 studies to assess the safety, tolerability and pharmacokinetics of a single ascending dose (SAD) or multiple ascending doses (MAD) in healthy volunteers. In these studies, APD371 was safe and well-tolerated. All adverse events were classified as mild, the most common of which were headache and nausea; one subject discontinued treatment due to adverse events and there were no serious adverse events. APD371 did not exhibit psychotropic effects that are commonly seen with cannabinoids. APD371 showed stable pharmacokinetics with no accumulation in blood plasma following repeated doses. In parallel preclinical studies, APD371 demonstrated full efficacy at human and rodent CB2 receptors in recombinant receptor cAMP, β-arrestin, and internalization pathways, and has an over thousand-fold selectivity over the cannabinoid 1 (CB1) receptor.

APD371 is currently being evaluated in a Phase 2 proof-of-concept trial for visceral pain associated with Crohn's disease.

"We are excited to present these initial APD371 preclinical and Phase 1 study data at the American Pain Society Summit," said Arena Pharmaceuticals Chief Medical Officer, Dr. Preston Klassen. "These studies establish that APD371 has the potential to be a transformative, non-opioid pain medication and we look forward to a readout from our Phase 2 study evaluating the efficacy of APD371 in treating pain associated with Crohn's disease."

The Scientific Summit will take place in Anaheim, Calif. on March 4-6, 2018.

Presentation Details
Title: APD371: A Potent, Highly Selective, Full Agonist of the Human CB2 Receptor with Sustained Analgesic Effects in Rodents
Poster Number: 100
Date/Time:  Tuesday, March 6, 11:30 a.m.12:30 p.m. PST
Location: Disneyland Hotel, Experience Exchange room

Title: Safety, Tolerability, and Pharmacokinetics of APD371, a Highly Selective CB2 Agonist, in Healthy Adults
Poster Number: 286
Date/Time:  Tuesday, March 6, 11:30 a.m.12:30 p.m. PST
Location: Disneyland Hotel, Experience Exchange room

About APD371
APD371 is an orally available, peripherally restricted, highly-selective, full agonist of the cannabinoid 2 (CB2) receptor. APD371 is an internally discovered investigational drug candidate that Arena is exploring for development in several indications, including visceral pain. This compound, through its selectivity for CB2, is designed to provide pain relief without psychotropic effects and without the potential for dependence or abuse. APD371 is currently in a Phase 2 evaluation for treatment of pain associated with Crohn's disease.

APD371 is an investigational compound not approved for any use in any country.

About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which is in Phase 2 for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "potential," "look forward to," "exploring," "designed to," "focused on," "potentially," "may," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's upcoming presentation at the APS Summit; APD371, including relating to its potential to be a transformative non-opioid pain medication and its ongoing Phase 2 clinical trial for pain associated with Crohn's disease; and Arena's position for the future, opportunities for catalysts, programs (including their first- or best-in-class potential), focus and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical programs may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to unexpected or unfavorable new data; and risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K which was filed on March 15, 2017 and our Quarterly Report on Form 10-Q which was filed on November 8, 2017. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Corporate Contact:                                      
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer 

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations 

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