Logical Therapeutics, Inc. (PITTSBURGH, Pa), an early-stage biotechnology company developing novel therapeutic agents to treat medical conditions caused by poorly controlled or excessive inflammatory responses, announced that it has completed a Seed round of financing in partnership with PA Early Stage Partners. The initial funding provided the resources to initiate operations, and to enter into a licensing and collaboration agreement with Medinox, Inc. (CARLSBAD, Calif.) to secure intellectual property rights for a novel nonsteroidal anti-inflammatory drug (NSAID), to be known as LT-NS001. Under the terms of the agreement, Logical Therapeutics has an exclusive license to develop and market LT-NS001 in North America, Europe, and Australia. In return, Medinox will receive an up-front payment, and is eligible to receive future payments upon achievement of certain development and regulatory milestones, as well as from royalties on sales. Logical Therapeutics intends to develop LT-NS001 for the treatment of mild to moderate inflammatory conditions such as osteoarthritis and low-back pain syndrome.

LT-NS001 is a patented, orally active anti-inflammatory agent that has been shown in animal studies to be as effective as the widely used NSAID, naproxen, for treating pain and inflammation. Furthermore, in animal models of NSAID-induced damage to the mucosal lining of the gastrointestinal (GI) tract, LT-NS001 was significantly less injurious than naproxen. LT-NS001 was evaluated in a phase I clinical trial. No serious adverse events were reported and no subjects withdrew from the study.

LT-NS001 is likely to be the identical composition of matter referred to by Medinox as MX-1094, an NSAID prodrug that is being developed to improve the GI safety profile of naproxen. In December 2002, Medinox completed a phase I clinical trial of MX-1094, conducted in The Netherlands. The trial was a randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study; its objective was to evaluate the safety profile, tolerability, and pharmacokinetics of MX-1094 in 48 healthy volunteers. The results show that MX-1094 is well-tolerated and exhibits the desired pharmacokinetic profile when compared with naproxen.

In Medinox's NSAID program, a known NSAID is joined using Medinox's patented linker technology to a proprietary protective group that results in a new chemical entity that is less damaging to the stomach and intestinal lining. In the stomach and the intestine, the protective group remains intact. When it is absorbed into the circulation, the conjugate is cleaved, freeing the NSAID. In preclinical studies, Medinox's novel NSAIDs have delivered the equivalent therapeutic benefits as their parent NSAIDs, but produce substantially fewer GI side effects.

— A. Techman

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