IP2015 / Initiator Pharma - LARVOL DELTA

"In the pain challenge few months ago vs @pfizer #pregabalin or #lyrica IP2015 statistically significant effect on Allodynia (Trigeminal Neuralgia, Migraine etc) and showed dose dependent effects on the measures pain parameters. Not much left in the pain segment. $30m mcap." (@BuffetOfSweden)

CNS Disorders • Migraine • Neuralgia • Pain

Initiator Pharma reports the final analysis of positive efficacy data from the IPTN2021 program Phase I study (Market Screener) - P1 | N=24 | NCT05181852 | Sponsor: Initiator Pharma | "Initiator Pharma A/S...announced today that the final dataset and study- report analysis have been obtained in the IPTN2021 program....The final analysis confirms the statistically significant effects on pain measures that were observed in the analysis of the first data read-out from the study presented in May 2022....In the assessment of subjective pain ratings, the mean values for IP2015 showed 2- and 5-fold higher effects compared to pregabalin and placebo, respectively. In support of these positive results, IP2015 demonstrated data in the Quantitative Sensory Test pain assessments related to pain in line with the primary pain assessments provided above. In the heat detection and thermal sensory (warm) threshold tests, respectively, statistically significant outcomes were detected for IP2015 when tested within test subjects."

P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Initiator Pharma reports positive efficacy data outcome of the IPTN2021 program Phase I study to assess pain-reducing effects (Market Screener) - P1 | N=24 | NCT05181852 | Sponsor: Initiator Pharma | "Initiator Pharma A/S...announced today that analysis of the first data read-out has been obtained in the IPTN2021 program clinical Phase I study in healthy subjects dosed with the drug substance IP2015, and challenged with a pain-inducing ingredient (capsaicin)....The pain was induced by intradermal capsaicin. IP2015 demonstrated a statistical significant effect on allodynia (p=0.049) and showed a dose-dependent effect on the measured pain parameters. Pregabalin (p=0.083) and IP2015 (p=0.051) tended to reduce hyperalgesia, although the effects on hypoalgesia were not statistically significant compared to placebo-treated subjects. In addition, there were no observations of unexpected adverse events. Further analysis of incoming data is in progress. A final report is expected in the third quarter of 2022 and the company plans to update the market at that time."

P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

"$INIT IP2015 superior to Duloxetin (Cymbalta) @LillyPad in both safety and efficiency. Right now undergoing fas1b pain study (indication = trigeminal Neuralgia) and benching against Pregabalin (Lyrica) @pfizer . Could be a game-changer. Results in the next 3-5 weeks" (@BuffetOfSweden)

Clinical • Neuralgia • Pain

Initiator Pharma completes dosing and last subject last visit in the IPTN2021 program Phase I study to assess pain-reducing effects (Market Screener, Market Screener) - "Initiator Pharma A/S...announced today that all planned subjects have had the last visit in Clinical part in the IPTN2021 program clinical Phase I study in healthy subjects challenged with the pain-inducing ingredient (capsaicin). All planned clinical activities for the 24 healthy male subjects have taken place in Initiator Pharma’s Phase I study in the IPTN2021 program that aims to target the treatment of trigeminal neuralgia....The obtained clinical data will now be undergoing data management, quality and statistical analysis. The data analysis will be related to the pain biomarkers collected, explore pharmacodynamic signals related to neuropathic pain and support future study designs related to trigeminal neuralgia pain. The first results are expected end of second quarter of 2022."

P1 data • Trial status • CNS Disorders • Neuralgia • Pain

Initiator Pharma completes dosing and last subject last visit in the IPTN2021 program Phase I study to assess pain-reducing effects (Market Screener, Market Screener) - "Initiator Pharma A/S...announced today that all planned subjects have had the last visit in Clinical part in the IPTN2021 program clinical Phase I study in healthy subjects challenged with the pain-inducing ingredient (capsaicin). All planned clinical activities for the 24 healthy male subjects have taken place in Initiator Pharma’s Phase I study in the IPTN2021 program that aims to target the treatment of trigeminal neuralgia....The obtained clinical data will now be undergoing data management, quality and statistical analysis. The data analysis will be related to the pain biomarkers collected, explore pharmacodynamic signals related to neuropathic pain and support future study designs related to trigeminal neuralgia pain. The first results are expected end of second quarter of 2022."

P1 data • Trial status • CNS Disorders • Neuralgia • Pain

Initiator Pharma completes inclusion of test subjects in the IPTN2021 program Phase I study to assess pain-reducing effects (Market Screener) - "Initiator Pharma A/S...announced today that all planned subjects have been included in the IPTN2021 program clinical Phase I study in healthy subjects challenged with the pain-inducing ingredient (capsaicin). The inclusion of all planned 24 healthy male subjects has taken place in Initiator Pharma’s Phase I study targeting trigeminal neuralgia....The study is carried out in collaboration with MAC Clinical Research, UK, as a single site study. The first results are expected during the second quarter of 2022."

Enrollment closed • P1 data • CNS Disorders • Neuralgia • Pain

Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Initiator Pharma

Clinical • New P1 trial • Pain

Initiator Pharma A/S : Correction of previously published press release regarding CTA-filing for Phase I study (Market Screener) - "Initiator Pharma has filed its Clinical Trial Application (CTA) for its planned Phase I study in healthy male subjects to the Medicines & Healthcare products Regulatory Agency, MHRA, UK. Subject inclusion and dosing is expected January 2022. The study will be carried out in collaboration with MAC Clinical Research, UK, as a single site study."

New P1 trial • Pain