Asarina Pharma AB (Publ)
Climate Impact & Sustainability Data (2018-01-01—2018-12-31)
Reporting Period: 2018-01-01—2018-12-31
Environmental Metrics
Social Achievements
- Initiated a Phase IIB PMDS study with remarkably low dropout rate (15%) compared to other studies (up to 33%).
- Received full support from the medical advisory board for the Phase IIA study protocol on menstrual migraine.
- Strengthened leadership team with appointments in medical, scientific, and strategic areas, including a Chief Medical Officer.
Governance Achievements
- Successful IPO on Nasdaq First North, raising over 150 million SEK.
Climate Goals & Targets
Medium-term Goals:
- Present topline results from Phase IIB PMDS study (beginning of 2020).
- Potentially initiate Phase III PMDS study (first half of 2021).
- Scale up production for Phase III PMDS study (2021).
- Present topline results from Phase IIA menstrual migraine study (end of 2020).
Short-term Goals:
- Complete Phase IIB PMDS study (Q1 2020).
- Obtain FDA IND approval for menstrual migraine (end of June 2019).
- Begin patient recruitment for menstrual migraine study (August 2019).
- Select an autoinjector for Phase III studies and commercialization (2019).
Environmental Challenges
- Competition in therapeutic areas with few active companies.
- Risks associated with clinical trials, including potential delays and cost overruns.
- Dependence on securing capital from investors.
- Exposure to currency fluctuations.
- Regulatory risks associated with obtaining necessary approvals from EMA and FDA.
Mitigation Strategies
- Continuous risk assessments and mitigation strategies.
- Careful monitoring of potential competitors.
- Diversification of drug candidates to spread risk.
- Thorough assessment of clinical study timelines and budgets.
- Continuous discussions with investors for future funding rounds.
- Hedging strategies to mitigate currency risk.
- Involvement of leading external experts in regulatory matters and clinical study design.