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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR
15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: May 12, 1997
AUTOIMMUNE INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-20948 13-3489062
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(State of incorporation (Commission (IRS Employer
or organization) File Number) Identification No.)
128 Spring Street, Lexington, MA 02173
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number: (617) 860-0710
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N/A
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(Former name or former address, if changed since last report.)
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ITEM 5. OTHER EVENTS.
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AutoImmune Inc. has received preliminary results from two Phase II trials
for Colloral(R) for the treatment of rheumatoid arthritis. Both trials
demonstrated positive trends for Colloral, although statistical significance was
not demonstrated versus placebo. Based on the data from these and previous
trials, the Company believes that Colloral has therapeutic benefit, but may
require further development before entering Phase III trials. The Company will
conduct additional analysis of the Colloral data before defining the next
development steps for this product.
One of the completed Phase II trials was a dose refinement trial, in which
patients received 5, 20, or 60 microgram (mcg) doses of the drug versus placebo.
Only patients with rheumatoid arthritis for nine years or less were admitted to
the study. The most favorable trends from baseline were the 60 mcg dose.
Colloral was safe and well tolerated by patients at all dose levels.
The second Phase II trial was designed to determine the clinical impact of
Colloral on patients abruptly withdrawn from methotrexate, a frequently used
disease modifying anti-rheumatic drug (DMARD). Patients received either 20 mcg
of Colloral or placebo, and were observed for six months. On an intent-to-treat
basis, more patients had a positive response by the Paulus criteria in the
Colloral group than the placebo group. Those patients who did not complete the
primary protocol were allowed to resume DMARD therapy if their physicians deemed
it necessary. Although more patients on Colloral than on placebo resumed DMARD
treatment, patients who continued on Colloral without DMARDs showed a
therapeutic benefit versus the matching placebo group. Colloral was again found
to be safe and well tolerated.
The presence of anti-type collagen antibodies in patients at baseline was
not a predictor of response to Colloral.
A third Phase II trial comparing Colloral to an active control remains
ongoing. Patients in the third Phase II trial are receiving either Colloral or
the anti-inflammatory drug, hydroxycholoroquine. The patients entered in this
trial were failing non-steroidal therapy and had not previously been treated
with DMARDS. Independent statisticians have conducted an interim analysis of
this study and recommended that the trial continue to completion. The Company
expects to receive a preliminary analysis of the results in July 1997.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
AUTOIMMUNE INC.
By: /s/ Robert C. Bishop
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Robert C. Bishop, Ph.D.
President and Chief Executive Officer
Date: May 19, 1997
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