Adolor begins human clinical trials with peripheral opiate antihyperalgesic for treatment of pain.

MALVERN, Penn.--(HealthWire)--Nov. 13, 1996--Adolor Corporation today announced the initiation of Phase I clinical trials for its peripheral opiate analgesic, ADL 2-1294. ADL 2-1294 is a proprietary opiate compound formulated to provide relief of hyperalgesia -- severe pain associated with inflammation -- following burns, abrasions, contusions or other cutaneous injuries. The Company also announced that preclinical data demonstrating the efficacy of ADL 2-1294 in animal models for inflammatory pain will be presented on November 19 at the Annual Meeting of the Society for Neuroscience in Washington, D.C.

Narcotics such as morphine are commonly used to activate opiate receptors in the brain to mediate analgesia, but frequently cause serious side effects such as respiratory depression, nausea, sedation and addiction. The sensory nerve endings in skin and joints also carry opiate receptors which are amenable targets for treatment with a topical opiate antihyperalgesic. It is known that local administration of low doses of opiates into inflamed, hyperalgesic tissue can result in significantly reduced pain sensitivity without side effects, a phenomenon known as peripheral opiate antihyperalgesia.

"We believe that ADL 2-1294 represents a new approach to treating extreme pain without the side effects of centrally acting opiates," stated John Farrar, Ph.D., President and CEO of Adolor Corporation. "The efficacy of ADL 2-1294 has been validated in preclinical studies and we are very excited to advance this product into the clinic."

The Phase I trials will assess ADL 2-1294's safety, tolerance, pharmacokinetics and topical sensitivity in 35 burn patient volunteers. Pending positive results from these trials, Adolor plans to begin two dose-ranging Phase II trials in patients with minor burns, abrasions and sunburn in the first half of 1997.

The preclinical data to be presented at the Annual Meeting of the Society for Neuroscience indicate that ADL 2-1294 is antihyperalgesic upon local administration in four different animal models of inflammatory pain with activity comparable to or better than morphine. Additionally, while ADL 2-1294 has a high affinity for the opiate receptor, the compound does not cross the blood-brain barrier in significant quantities, but acts selectively on peripheral opiate receptors at the site of the injury.

Burn pain is significantly undertreated. Annually in the U.S., 130,000 burns require hospitalization and another 2.5 million less severe burns require medical care. Beyond the topical skin formulation of ADL 2-1294 for burn pain, Adolor has also begun preclinical development of an ophthalmic formulation of ADL 2-1294 to treat ocular pain. Indications for this formulation include corneal abrasion, keratoconjunctivitis, and radial keratectomy.

Adolor Corporation is a biopharmaceutical company committed to the development of the next generation of novel analgesics and related therapeutics for the treatment of pain based upon recent advances in proprietary medicinal chemistry and recombinant opiate receptor technology. The Company is unique in combining near-term clinical opportunities with a longer term approach to developing novel opiate analgesics. In March 1996, Adolor raised $9.6 million in a private financing led by TL Ventures, which also included Alta Partners; and OneLiberty Ventures, as well as the original investors ARCH Development; Falcon Technologies; and Weiss, Peck & Greer.

CONTACT: John J. Farrar, Ph.D. James W. Heins

President and CEO Burns McClellan, Inc.

Adolor Corporation [phone]

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