Apitope, a drug discovery and development firm, has completed its second Phase I clinical trial of ATX-MS-1467 treatment with positive results.
When patients with relapsing multiple sclerosis (MS) were treated with intradermal injection of ATX-MS-1467, the MRI results showed a decrease in the number of contrast-enhancing brain lesions (CEL).
Based on the encouraging preliminary results of a Phase I clinical trial in six patients with secondary progressive MS (SPMS), a second Phase I clinical trial has been completed to assess the safety of ATX-MS-1467, as well as biological parameters, in a total of 43 patients with relapsing MS.
While the primary endpoint of the recently completed trial was safety and tolerability, as assessed by adverse effects and MRI scans, the secondary endpoint was to identify early signs of efficacy.
Apitope CEO Keith Martin said: "The results of this trial in patients with relapsing MS continue to build on the positive data from our first study and provide further clinical support for the Apitope approach to the treatment of serious autoimmune conditions."
According to Apitope, ATX-MS-1467 treatment is aimed at working with the immune system to treat the underlying cause of disease and restoring immunological balance, rather than just treating the symptoms or suppressing the complete immune system.
Apitope CSO and founder David Wraith said antigen specific immunotherapy is designed to correct the immunological imbalance that causes autoimmune disease without inducing the non-specific immune suppression that so frequently causes unacceptable side effects.
"Up to now, this approach has been shown to be highly effective in experimental models but has been slow to progress into the clinic," Wraith said.
"It is, therefore, a major step forward that the approach is proving to be so well tolerated with early signs of potential efficacy, as evidenced by the results of Apitope’s two clinical trials in MS."
The results enable Merck Serono, which Apitope is developing ATX-MS-1467 with, to advance its Phase II plans.
ATX-MS-1467 is being developed under an agreement between Apitope and Merck Serono, pursuant to which, Phase I clinical trial is carried out by Apitope, while all development activities from the beginning of Phase II clinical trials will be overseen by Merck Serono.