SARcode reports positive results from Phase I ocular inflammatory trial

SARcode, a biopharmaceutical company, has announced the results of its Phase I randomized, double-masked, placebo-controlled trial of the safety, tolerability, and pharmacokinetics of single- and multiple-escalating doses of SAR 1118 ophthalmic solution in healthy volunteers.

SAR 1118 was well-tolerated and demonstrated a favorable safety profile when administered by topical ocular instillation up to three times daily at dose strengths of up to 5%.

The Phase I trial was designed to evaluate the local and systemic safety and pharmacokinetic parameters of SAR 1118 ophthalmic solution in the plasma and tear of 28 healthy adults at four dose strengths (0.1, 0.3, 1 and 5%). The dosing schedule was divided into three periods in which subjects received SAR 1118 as a single dose, twice daily for 10 days and then three times daily for 10 days with a 72-hour wash-out interval between study periods and a two-week observation period following dosing completion.

Ocular assessments including slit-lamp examination, visual acuity, Schirmer tear test, tear film break-up time, and intraocular pressure were obtained at screening as well as at the beginning and completion of each period. Masked safety data was reviewed by a safety committee prior to allowing dose-escalation. All subjects completed the trial and no doses were missed. The pharmacokinetic parameters demonstrated adequate ocular exposure at all three dose schedules with minimal systemic exposure.

Based upon these results, SARcode has selected dose strengths and dose schedules for its Phase II programs in allergic conjunctivitis and dry eye. Data for these programs is expected in 2009. With emerging data in preclinical animal models, SARcode may choose to pursue other ocular inflammatory conditions including diabetic retinopathy and age-related macular degeneration in the near future.

Charles Semba, chief medical officer of SARcode, said: We are pleased with the results of our initial human clinical study to characterize the safety and tolerability of SAR 1118. This compound represents the first-in-class novel anti-inflammatory agent to be advanced as an ocular therapy. The Phase I data suggests that SAR 1118 is well-tolerated with an acceptable pharmacokinetic profile to treat patients with ocular inflammatory conditions. We look forward to Phase II clinical trial results later in 2009.