Press Releases

PRESS RELEASE

15th December, 2017

Initiator Pharma, a biotech company developing a novel treatment of Erectile Dysfunction (ED), has successfully completed an in vivo 28 days toxicology study in mini-pigs for its drug candidate IPED2015, thus moving the development program forward towards the Clinical Trial Application (CTA) and with the aim of initiating a Phase 1 clinical trial next year.

Initiator Pharma A/S, a Danish Biotech Company developing a novel treatment of Erectile Dysfunction (ED), has received very positive preliminary results from its first Good Laboratory Practice (GLP) toxicology and toxicokinetic rat study at Syngene, Bangalore, India.

Initiator Pharma A/S, a Danish Biotech Company developing a novel treatment of Erectile Dysfunction (ED), has initiated its first Good Laboratory Practice (GLP) toxicology and toxicokinetic rat study at Syngene, Bangalore, India.

The warrant program 2017/2020, comprising a maximum of 434,197 warrants as resolved at the Annual General Meeting of 16 May 2017, has been fully subscribed. Subscription of warrants have been submitted by employees, board members and key consultants, in total 7 persons, according to Appendix 2 to the AGM protocol from 16 May, 2017. The warrants are transferred to participants at a price of SEK 0.49 per warrant, equivalent to the market value according to an external independent valuation, applying the Black & Scholes model. The warrants are subject to vesting conditions described in Appendix 4c of the AGM protocol from 16 May, 2017. Upon vesting, each warrant entitles subscription of one new share at a price per share of approximately SEK 4.34 on or before 30 January, 2020.

The first maximum tolerated dose toxicology and toxicokinetic mini-pig studies have been conducted at RTC, Rome, Italy, under the supervision of Initiator Pharma’s CDO Mikael Thomsen. The data are in line with what was observed in comparable rat studies already executed and supports the further development of IPED2015 with the aim to start clinical trials in 2018.

The first exploratory toxicology and pharmacokinetic rat studies have been conducted at Syngene, India under the supervision of Initiator Pharma’s CDO Mikael Thomsen. The data are promising and supports the next planned non-clinical safety studies for IPED2015.

Initiator Pharma has over the recent months developed a robust and efficient drug substance synthesis route together with CRO partner, Syngene, under the supervision of Initiator Pharma’s CTO Dan Peters and CDO Mikael Thomsen.