PMDA supports InDex’s development plan for cobitolimod in Japan
“With great interest from the clinics for our phase III study CONCLUDE and cobitolimod, our successful interactions with the Japanese regulatory authority PMDA, as well as with a strengthened patent portfolio, InDex is strongly equipped for cobitolimod’s path towards market approval”, says Johan Giléus, acting CEO of InDex Pharmaceuticals.
Period April – June 2022
- Net sales amounted to SEK 0.0 (0.0) million
- Operating loss amounted to SEK –21.7 (–42.6) million
- Result after tax amounted to SEK –21.7 (–42.6) million, corresponding to SEK –0.04 per share (–0.08) before and after dilution
- Cash flow from operating activities amounted to SEK –53.0 (–45.1) million
Period January – June 2022
- Net sales amounted to SEK 0.0 (0.0) million
- Operating loss amounted to SEK –40.6 (–51.9) million
- Result after tax amounted to SEK –40.6 (–52.0) million, corresponding to SEK –0.08 per share (–0.11) before and after dilution
- Cash flow from operating activities amounted to SEK –71.4 (–53.6) million
- Cash and cash equivalents at the end of the period amounted to SEK 395.6 (478.8) million
- Number of employees at the end of the period was 7 (7)
- Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2021.
Significant events during the quarter
- Peter Zerhouni stepped down as CEO of InDex. The company’s CFO Johan Giléus has been appointed acting CEO while a new CEO is being recruited
- InDex strengthened the organisation with Eva Arlander as Chief Development Officer and presented a new management team
Significant events after the reporting period
- InDex got a new patent for cobitolimod granted in Europe
- InDex participated with a booth at the Digestive Disease Week (DDW) in San Diego
- The annual general meeting in InDex Pharmaceuticals Holding AB was held on June 1, 2022
We remain fully focused on the implementation of the phase III study CONCLUDE, which evaluates the drug candidate cobitolimod as a new and unique treatment for patients with moderate to severe left-sided ulcerative colitis. The study is progressing according to plan, i.e. we expect the results to be available during H2 2023. We see great interest in the study and cobitolimod when we, together with our experienced CRO, Parexel Biotech, visit the participating clinics. In the beginning of July, we invited all CRAs of the study, i.e. Parexel’s employees who have ongoing contact with the participating clinics, to a two-day meeting in Stockholm. The purpose of the meeting was to jointly discuss the CONCLUDE study and the benefits of cobitolimod.
At the end of June, the planned consultation meeting with the Japanese regulatory authority, PMDA, was held. It was very encouraging that the PMDA supports our proposed clinical development plan for cobitolimod and that they agree to include Japanese patients in our second induction study in the phase III program, without conducting any specific clinical studies in Japanese subjects. In addition, complementary pharmacokinetic data for cobitolimod in Japanese patients can be collected during the remaining phase III program. This is a unique decision by the PMDA, indicating great potential for cobitolimod and a need for new treatment options that can help more patients with moderate to severe ulcerative colitis. In addition, the positive feedback from PMDA is advantageous for discussions with potential candidates for strategic collaborations in Japan.
At the end of May, InDex participated with a booth at the premier medical congress in the world in gastroenterology, the Digestive Disease Week (DDW) in San Diego, USA. Our participation was very successful and resulted in many valuable contacts, and several new clinics expressed interest to join our phase III study with cobitolimod. We will take the experience with us when we now plan for our participation in the United European Gastroenterology Week (UEGW) in October.
In parallel with the global clinical phase III study CONCLUDE, InDex is conducting a smaller clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. The patient recruitment in the PK study has gone faster than expected and the study is well underway. The aim of the study is to confirm that the systemic uptake of cobitolimod is limited, which has been shown in previous preclinical and clinical studies. The study will include at least 6 patients with moderate to severe ulcerative colitis treated with doses of 500 mg of cobitolimod administered rectally. A limited systemic uptake is a significant advantage compared to competing drugs for ulcerative colitis that act on the whole body and can cause severe side effects outside the inflamed colon.
In July, we announced that a new patent for cobitolimod has been granted in Europe. The patent provides additional protection for the use of cobitolimod in the treatment of inflammatory bowel disease. The patent provides an exclusivity period until August 2040, and further strengthens, broadens and extends our robust intellectual property position for cobitolimod in Europe. Corresponding patent applications have been filed in the strategically most important patent territories globally.
With great interest from the clinics for our phase III study and cobitolimod, our successful interactions with the Japanese regulatory authority, as well as with a strengthened patent portfolio, I look forward to an exciting and eventful fall where we will take important steps forward for InDex.
Johan Giléus, acting CEO
For more information:
Johan Giléus, acting CEO
Phone: +46 8 122 038 50
E-mail: [email protected]
The full report is attached as a PDF and is available on the company’s website https://www.indexpharma.com/en/financial-reports/
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on August 26, 2022.
InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s lead asset is the drug candidate cobitolimod, which is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.
InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.